Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-20 @ 12:46 PM
Study NCT ID:
NCT02760602
Status:
TERMINATED
Last Update Posted:
2019-10-10
First Post:
2016-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Belgium', 'Netherlands', 'South Korea', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C550616', 'term': 'solanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated due to insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to pts with prodromal AD as defined by the study protocol. Zero pts were analyzed as no data collected for outcomes.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Study Termination (Up To 11 Months)', 'eventGroups': [{'id': 'EG000', 'title': 'Solanezumab', 'description': 'Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Endodontic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Mini Mental Status Examination (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Montreal Cognitive Assessment (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Functional Activities Questionnaire (FAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': "FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did \\[the activity\\] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Neuropsychiatric Inventory (NPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': "The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': "CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': "RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': "EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': "Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'Concentration of amino acid peptide known as Aβ 1-42 in plasma.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'MRI will be used to assess the effect of treatment on rate of whole brain volume.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'timeFrame': 'Baseline, 24 Months', 'description': 'Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Solanezumab', 'description': 'Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'Participants were randomized by site and by use of florbetapir positron emission tomography (PET) scanning or cerebrospinal fluid (CSF) for study eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Solanezumab', 'description': 'Solanezumab given IV once every 4 weeks for up to 2 years.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo given IV once every 4 weeks for up to 2 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.46', 'spread': '6.01', 'groupId': 'BG000'}, {'value': '75.62', 'spread': '4.93', 'groupId': 'BG001'}, {'value': '74.54', 'spread': '5.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'ADAS-Cog14 at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '24.08', 'spread': '8.00', 'groupId': 'BG000'}, {'value': '27.77', 'spread': '3.63', 'groupId': 'BG001'}, {'value': '25.92', 'spread': '6.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All enrolled participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-28', 'size': 778799, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-02T05:31', 'hasProtocol': True}, {'date': '2017-03-08', 'size': 403599, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-02T05:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to participants with prodromal AD as defined by study protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2016-05-02', 'resultsFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-25', 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score', 'timeFrame': 'Baseline, 24 Months', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)', 'timeFrame': 'Baseline, 24 Months', 'description': 'The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.'}, {'measure': 'Change From Baseline on the Mini Mental Status Examination (MMSE)', 'timeFrame': 'Baseline, 24 Months', 'description': 'MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.'}, {'measure': 'Change From Baseline on the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline, 24 Months', 'description': 'The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.'}, {'measure': 'Change From Baseline on the Functional Activities Questionnaire (FAQ)', 'timeFrame': 'Baseline, 24 Months', 'description': "FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did \\[the activity\\] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment."}, {'measure': 'Change From Baseline on the Neuropsychiatric Inventory (NPI)', 'timeFrame': 'Baseline, 24 Months', 'description': "The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity."}, {'measure': 'Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)', 'timeFrame': 'Baseline, 24 Months', 'description': "CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity."}, {'measure': 'Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': 'Baseline, 24 Months', 'description': 'RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.'}, {'measure': 'Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)', 'timeFrame': 'Baseline, 24 Months', 'description': 'The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.'}, {'measure': 'Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)', 'timeFrame': 'Baseline, 24 Months', 'description': "RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews."}, {'measure': 'Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)', 'timeFrame': 'Baseline, 24 Months', 'description': "EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity."}, {'measure': "Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)", 'timeFrame': 'Baseline, 24 Months', 'description': 'QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.'}, {'measure': 'Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab', 'timeFrame': 'Baseline, 24 Months', 'description': 'Concentration of amino acid peptide known as Aβ 1-42 in plasma.'}, {'measure': 'Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)', 'timeFrame': 'Baseline, 24 Months', 'description': 'MRI will be used to assess the effect of treatment on rate of whole brain volume.'}, {'measure': 'Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)', 'timeFrame': 'Baseline, 24 Months', 'description': 'Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.'}, {'measure': 'Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins', 'timeFrame': 'Baseline, 24 Months', 'description': 'Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.'}, {'measure': 'Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET', 'timeFrame': 'Baseline, 24 Months', 'description': 'Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anti-amyloid', 'monoclonal antibody'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrialguide.com/en-US/studies/mild-cognitive%20impairment/LZBE#?postal=', 'label': "Click here for more information about this study: A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease"}]}, 'descriptionModule': {'briefSummary': "The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.\n* Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.\n* Scores \\<27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.\n* Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).\n* Scores \\>0 on the Functional Activities Questionnaire (FAQ).\n* Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.\n\nExclusion Criteria:\n\n* Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.\n* Has known allergy to humanized monoclonal antibodies.\n* Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.\n* Has screening MRI with results showing \\>4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.\n* Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.\n* Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)"}, 'identificationModule': {'nctId': 'NCT02760602', 'acronym': 'ExpeditionPRO', 'briefTitle': "A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': "A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease", 'orgStudyIdInfo': {'id': '16349'}, 'secondaryIdInfos': [{'id': 'H8A-MC-LZBE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-000108-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solanezumab', 'description': 'Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.', 'interventionNames': ['Drug: Solanezumab']}, {'type': 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'National Clinical Research - Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Professional Plaza', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '53562', 'city': 'Middleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Dean Foundation for Health Research and Education', 'geoPoint': {'lat': 43.09722, 'lon': -89.50429}}, {'zip': 'J8T 8J1', 'city': 'Gatineau', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'J4V 2J2', 'city': 'Greenfield Park', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'B3S1M7', 'city': 'Halifax', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B4N 4K9', 'city': 'Kentville', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.0771, 'lon': -64.49605}}, {'zip': 'N6C 0A7', 'city': 'London', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'KIN 5C8', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K9H2P4', 'city': 'Peterborough', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'J1H1Z1', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'M3B 2S7', 'city': 'Toronto', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20014', 'city': 'Turku', 'country': 'Finland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '65130', 'city': 'Vaasa', 'country': 'Finland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 63.096, 'lon': 21.61577}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '09131', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20052', 'city': 'Monza', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '06134', 'city': 'Perugia', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00153', 'city': 'Roma', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00179', 'city': 'Roma', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00189', 'city': 'Roma', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '113-8431', 'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '113-8655', 'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '193-0998', 'city': 'Hachiōji', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '673-0848', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '247-8533', 'city': 'Kamakura', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '187-8551', 'city': 'Kodaira-shi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '963-8052', 'city': 'Kōriyama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.4, 'lon': 140.38333}}, {'zip': '607-8113', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '181-0013', 'city': 'Mitaka-shi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '160-8582', 'city': 'Shinjuku-Ku', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '424-0911', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '760-8557', 'city': 'Takamatsu', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '113-0034', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '514-8507', 'city': 'Tsu', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '15-732', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-796', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '20-093', 'city': 'Lublin', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '30-856', 'city': 'Poznan', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '81-824', 'city': 'Sopot', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '01-697', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '00961-6911', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Santa Cruz Behavioral PSC', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00771', 'city': 'Las Piedras', 'country': 'Puerto Rico', 'facility': 'Cortex, PSC', 'geoPoint': {'lat': 18.18301, 'lon': -65.86627}}, {'zip': '00936', 'city': 'Rio Piedras', 'country': 'Puerto Rico', 'facility': 'University Of Puerto Rico', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Instituto de Neurologia Dra. Ivonne Fraga', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Latin Clinical Trial Center', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'SomniCare Sleep Institute', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '08014', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '12004', 'city': 'Castellon', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '20009', 'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '28905', 'city': 'Getafe', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '48993', 'city': 'Getxo', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.35689, 'lon': -3.01146}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '10600', 'city': 'Plasencia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.03116, 'lon': -6.08845}}, {'zip': '17190', 'city': 'Salt', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.97489, 'lon': 2.79281}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '43141', 'city': 'Mölndal', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'zip': '113 61', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '90105', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '333', 'city': 'Gwei Shan Township', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '80756', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '70403', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '235', 'city': 'Zhonghe', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.99298, 'lon': 121.49385}}, {'zip': 'BA1 3NG', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'W6 8RF', 'city': 'Chelsea', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.48755, 'lon': -0.16936}}, {'zip': 'GU2 7YD', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'W1G 9RU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'G20 0XA', 'city': 'Scotland', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.8578, 'lon': -1.64198}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}