Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-29 @ 10:11 AM
Study NCT ID:
NCT05291234
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2022-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Italy', 'Japan', 'Portugal', 'Spain']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to approximately 160 weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.'}, {'measure': 'Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'Cmax of ABBV-916 will be determined.'}, {'measure': 'Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'Tmax of ABBV-916 will be determined.'}, {'measure': 'Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.'}, {'measure': 'Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'T1/2 of ABBV-916 will be determined.'}, {'measure': 'Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'Ctrough of ABBV-916 will be determined.'}, {'measure': 'Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'AUC of ABBV-916 will be determined.'}, {'measure': 'Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'The central value for ratio of ABBV-916 concentration in cerebrospinal fluid (CSF) to that in serum will be estimated for evaluation of the fraction of ABBV-916 crossing the blood brain barrier.'}, {'measure': 'Stage A: Percentage of Participants With Antidrug Antibodies (ADA) as a Measure of Immunogenicity Following Multiple Ascending Dose of ABBV-916', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.'}, {'measure': 'Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value)', 'timeFrame': 'Baseline (Week 0) through Week 24', 'description': 'Change from baseline in brain amyloid plaque deposition (amyloid centiloid value) is measured by amyloid positron emission tomography (PET) scan.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease (AD)", "Early Alzheimer's Disease", 'ABBV-916'], 'conditions': ["Alzheimer's Disease (AD)"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M22-721', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Alzheimer\'s disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body of participants will be assessed.\n\nABBV-916 is an investigational drug being developed for the treatment of early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are "double-blind," which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 participants aged 50-90 years will be enrolled in about 90 sites across the world.\n\nParticipants will receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for an additional 16 weeks. Participants will have the option of participating in a 2-year, open-label, Extension Period receiving IV ABBV-916.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, magnetic resonance imaging (MRI), blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria.\n\n * Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.\n * Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria.\n* Amyloid PET scan results consistent with amyloid pathology.\n* Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant.\n\nExclusion Criteria:\n\n* Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease.\n* Any anticoagulants or have a bleeding disorder that is not adequately controlled."}, 'identificationModule': {'nctId': 'NCT05291234', 'briefTitle': "A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'M22-721'}, 'secondaryIdInfos': [{'id': '2022-500691-59-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage A: ABBV-916', 'description': 'Participants will receive ABBV-916 for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.', 'interventionNames': ['Drug: ABBV-916']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage A: Placebo for ABBV-916', 'description': 'Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Stage B: ABBV-916 Dose A', 'description': 'Participants will receive ABBV-916 Dose A for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.', 'interventionNames': ['Drug: ABBV-916']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage B: Placebo for ABBV-916', 'description': 'Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Stage B: ABBV-916 Dose B', 'description': 'Participants will receive ABBV-916 Dose B for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.', 'interventionNames': ['Drug: ABBV-916']}], 'interventions': [{'name': 'ABBV-916', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['Stage A: ABBV-916', 'Stage B: ABBV-916 Dose A', 'Stage B: ABBV-916 Dose B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['Stage A: Placebo for ABBV-916', 'Stage B: Placebo for ABBV-916']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710-6152', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Neuroscience Research /ID# 244957', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Irvine Clinical Research /ID# 239469', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92103-2204', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research - San Diego /ID# 244508', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network, Inc. /ID# 244083', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Syrentis Clinical Research /ID# 239682', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Aventura Neurological Associates /ID# 243892', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '32162', 'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'facility': 'Charter Research - Lady Lake /ID# 244657', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'zip': '33462-1141', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'JEM Research Institute /ID# 239122', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'ClinCloud - Maitland /ID# 244507', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32940-8288', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'ClinCloud LLC - Viera/Melbourne /ID# 240635', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '32952-3616', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Merritt Island Medical Research /ID# 239495', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'zip': '33125-4013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Optimus U /ID# 245868', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Finlay Medical Research /ID# 245996', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Allied Biomedical Res Inst Inc /ID# 244823', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34470', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research /ID# 240153', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34761-4547', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'K2 Medical Research - Ocoee /ID# 246849', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '32751', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32803-1839', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Charter Research - Winter Park /ID# 244778', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Headlands Research - Orlando /ID# 239119', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates Ormond Beach /ID# 245527', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33157', 'city': 'Palmetto Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'IMIC Inc. Medical Research /ID# 245900', 'geoPoint': {'lat': 25.62177, 'lon': -80.32477}}, {'zip': '34997-5765', 'city': 'Stuart', 'state': 'Florida', 'country': 'United States', 'facility': "Alzheimer's Research and Treatment Center - Stuart /ID# 245477", 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': "Alzheimer's Research and Treatment Center - Wellington /ID# 245201", 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '33407-3209', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Premiere Research Institute - Palm Beach /ID# 240108', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '32789-4681', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site Partners (CSP) - Orlando /ID# 245127', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Conquest Research /ID# 243916', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Memory Center /ID# 245054', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '48334-2977', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'QUEST Research Institute /ID# 239459', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '08755-5043', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Memory Research Institute of NJ /ID# 239533', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '19462', 'city': 'Plymouth Meeting', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Keystone Clinical Studies LLC /ID# 239973', 'geoPoint': {'lat': 40.10233, 'lon': -75.27435}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc /ID# 244917', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031-5207', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Re:Cognition Health - Fairfax VA /ID# 239501', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}