Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-02 @ 7:17 AM
Study NCT ID:
NCT03713957
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2018-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@alkahest.com', 'phone': '(650) 801-0474', 'title': 'Head of Communications', 'organization': 'Alkahest, Inc.'}, 'certainAgreement': {'otherDetails': 'The Clinical Trial Agreement contains language that restricts the PI from discussing or publishing Sponsor confidential and/or proprietary information. The embargo period may be extended by mutual agreement of the Sponsor and PI.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 Months', 'eventGroups': [{'id': 'EG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 45, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 20, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure diastolic decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'title': 'Participants with at least one TEAE', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Participants with at least one SAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 24 Months', 'description': 'Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all subjects at least one dose of the study agent. All safety analyses were performed using the Safety Set, based on treatment received.'}, {'type': 'SECONDARY', 'title': 'The Montreal Cognitive Assessment (MoCA) Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '3.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 16', 'description': 'Change from baseline in the The Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point test, which assess the attention and concentration, executive functions, memory, visuospatial abilities, language abilities, conceptual thinking, calculations, and orientation. Higher scores indicate better cognitive function; the total possible score is 30 and a score of 26 or more is considered normal. A positive value of change means an improvement, and a negative value of change means deterioration. Score range \\[0 (min) - 30 (Max)\\].', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'title': 'Continuity of Attention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Reaction Time Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '8.40', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Episodic Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.02', 'spread': '15.82', 'groupId': 'OG000'}, {'value': '8.65', 'spread': '15.82', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores:\n\n* Continuity of Attention: Min: - 20 # ; 35 #\n* Reaction Time Variability: Min: 0 #; Max: 900 #\n* Quality of Working Memory: Min : 0 # ; Max: 2 #\n* Quality of Episodic Memory: Min: -400 #; Max: 400 #\n\nNote: # denotes "no specific unit"\n\nLower scores reflect poorer ability for Continuity of Attention, Quality of Working Memory, and Quality of Episodic Memory; thus, a negative change from baseline reflects impairment compared to baseline. Whereas, for Reaction Time Variability, higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the Evaluable set comprised of subjects who receive all 10 planned doses, who complete Visit 18 and Visit 19 in window, and who do not have any of the deviations listed below or any other deviation that could potentially affect the assessment of efficacy identified prior to database lock.'}, {'type': 'SECONDARY', 'title': 'The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '-3.12', 'upperLimit': '13.13'}, {'value': '-1.59', 'groupId': 'OG001', 'lowerLimit': '-11.77', 'upperLimit': '8.58'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'Change from baseline in the Delis-Kaplan Executive Function System (D-KEFS). The D-KEFS Verbal Fluency test is used for assessment of executive function and has three conditions: Letter Fluency, Category Fluency, and Category Switching. Higher scores indicate more correct responses. A positive value of change means an improvement and a negative value of change means deterioration. The minimum score is 0 and there is no concrete maximum score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.89', 'groupId': 'OG000', 'lowerLimit': '-13.74', 'upperLimit': '-4.04'}, {'value': '-9.53', 'groupId': 'OG001', 'lowerLimit': '-16.43', 'upperLimit': '-2.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 16', 'description': "Change from baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS contains 4 subscales: Part 1, Mentation, Behavior, and Mood; Part 2, Activities of Daily Living; Part 3, Motor; Part 4, Complications nonmotor experiences of daily living (13 items), motor experiences of daily living (13 items), motor examination (18 items), and motor complications (six items). The rating for each item is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores. For this study, Parts 1-3 will be completed. Part 1 score ranges from 0 to 52. Part 2 score ranges from 0 to 52. Part 3 score ranges from 0 to 132. Total score possible is 0 to 236.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Schwab and England Activities of Daily Living (SE-ADL) Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'title': '100% Independency', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '90% Independency', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '80% Independency', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '70% Independency', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '60% Independency', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '50% Independency', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '40% Independency', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '30% Independency', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '20% Independency', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '10% Independency', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '0% Independency', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'title': '100% Independency', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '90% Independency', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '80% Independency', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '70% Independency', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '60% Independency', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '50% Independency', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '40% Independency', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '30% Independency', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20% Independency', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '10% Independency', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '0% Independency', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change from Baseline to Week 24', 'description': "Change from baseline in the Schwab and England Activities of Daily Living (SE-ADL). The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100%, normal status; 0%, bedridden with vegetative dysfunction), so that the lower the score, the worse the functional status. The range is 0% to 100%.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference between the Number Analyzed at Baseline and week 24 timepoint is due the withdrawal of participants or missed assessments.'}, {'type': 'SECONDARY', 'title': 'The Clinical Impression of Severity Index - PD (CISI-PD).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'groupId': 'OG000', 'lowerLimit': '-1.91', 'upperLimit': '0.83'}, {'value': '-0.55', 'groupId': 'OG001', 'lowerLimit': '-2.34', 'upperLimit': '1.24'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'Change from baseline in The Clinical Impression of Severity Index PD (CISI-PD). The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled); the possible scores range from 0 to 24. A total score is calculated by summing the item scores. Higher scores indicate worse severity. A negative value of change means an improvement and a positive value of change means deterioration.', 'unitOfMeasure': 'change from baseline score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.88', 'groupId': 'OG000', 'lowerLimit': '-11.46', 'upperLimit': '1.69'}, {'value': '-6.29', 'groupId': 'OG001', 'lowerLimit': '-14.81', 'upperLimit': '2.23'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 20', 'description': "Change from baseline in the Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). The PDQ-39 is a self-administered questionnaire of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. It is scored on a scale of 0 -100 with lower scores indicating better health and high scores indicating more severe symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Geriatric Depression Scale-15 (GDS-15).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '-1.30', 'upperLimit': '1.89'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '-1.74', 'upperLimit': '2.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'Change from baseline in the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item yes/no questionnaire of depression in older adults. Each depressive answer is 1 point. The final score is the tally of the number of depressive answers with the following scores indicating depression: 0-4 No depression; 5-10 Suggestive of a mild depression; 11 + Suggestive of severe depression. The possible scores range from 0 - 15.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Digital Clock Drawing Test (dCDT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.25', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '16.80'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '-7.61', 'upperLimit': '10.77'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 20', 'description': "Change from baseline in the digital clock drawing test (dCDT). The pen-like dCDT device will be used to gather the x-y coordinates that describe the movement of the stylus as it changes its position during the assessment. It also assesses when the stylus or writing device is not exerting pressure on the writing surface. The dCDT score is a number from 0 and 100 that represents a person's overall cognitive function as assessed by DCT clock. The total possible score is 100. A negative value of change means a deterioration and a positive value of change means an improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'classes': [{'title': 'Power of Attention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.14', 'spread': '90.89', 'groupId': 'OG000'}, {'value': '133.32', 'spread': '90.89', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-49.49', 'spread': '75.69', 'groupId': 'OG000'}, {'value': '35.45', 'spread': '75.69', 'groupId': 'OG001'}]}]}, {'title': 'Speed of Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.97', 'spread': '331.56', 'groupId': 'OG000'}, {'value': '232.33', 'spread': '331.56', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores:\n\n* Power of Attention: Min: 350 ms ; Max: 60000 ms\n* Cognitive Reaction Time: Min: - 30000 ms; Max : 30000 ms\n* Speed of Memory: Min 800 ms; Max: 120000 ms\n\nHigher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline.', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the Evaluable set comprised of subjects who receive all 10 planned doses, who complete Visit 18 and Visit 19 in window, and who do not have any of the deviations listed below or any other deviation that could potentially affect the assessment of efficacy identified prior to database lock.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.\n\nGRF6021: GRF6021 for IV infusion'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.\n\nPlacebo: Placebo for IV infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '7.63', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '8.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '68', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-23', 'size': 8397667, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-02T19:09', 'hasProtocol': True}, {'date': '2020-08-17', 'size': 7994473, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-02T19:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2018-10-18', 'resultsFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-05', 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Approximately 24 Months', 'description': 'Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class'}], 'secondaryOutcomes': [{'measure': 'The Montreal Cognitive Assessment (MoCA) Score.', 'timeFrame': 'Change from Baseline to Week 16', 'description': 'Change from baseline in the The Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point test, which assess the attention and concentration, executive functions, memory, visuospatial abilities, language abilities, conceptual thinking, calculations, and orientation. Higher scores indicate better cognitive function; the total possible score is 30 and a score of 26 or more is considered normal. A positive value of change means an improvement, and a negative value of change means deterioration. Score range \\[0 (min) - 30 (Max)\\].'}, {'measure': 'Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores:\n\n* Continuity of Attention: Min: - 20 # ; 35 #\n* Reaction Time Variability: Min: 0 #; Max: 900 #\n* Quality of Working Memory: Min : 0 # ; Max: 2 #\n* Quality of Episodic Memory: Min: -400 #; Max: 400 #\n\nNote: # denotes "no specific unit"\n\nLower scores reflect poorer ability for Continuity of Attention, Quality of Working Memory, and Quality of Episodic Memory; thus, a negative change from baseline reflects impairment compared to baseline. Whereas, for Reaction Time Variability, higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline.'}, {'measure': 'The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'Change from baseline in the Delis-Kaplan Executive Function System (D-KEFS). The D-KEFS Verbal Fluency test is used for assessment of executive function and has three conditions: Letter Fluency, Category Fluency, and Category Switching. Higher scores indicate more correct responses. A positive value of change means an improvement and a negative value of change means deterioration. The minimum score is 0 and there is no concrete maximum score.'}, {'measure': "The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.", 'timeFrame': 'Change from Baseline to Week 16', 'description': "Change from baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS contains 4 subscales: Part 1, Mentation, Behavior, and Mood; Part 2, Activities of Daily Living; Part 3, Motor; Part 4, Complications nonmotor experiences of daily living (13 items), motor experiences of daily living (13 items), motor examination (18 items), and motor complications (six items). The rating for each item is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores. For this study, Parts 1-3 will be completed. Part 1 score ranges from 0 to 52. Part 2 score ranges from 0 to 52. Part 3 score ranges from 0 to 132. Total score possible is 0 to 236."}, {'measure': 'The Schwab and England Activities of Daily Living (SE-ADL) Scale.', 'timeFrame': 'Change from Baseline to Week 24', 'description': "Change from baseline in the Schwab and England Activities of Daily Living (SE-ADL). The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100%, normal status; 0%, bedridden with vegetative dysfunction), so that the lower the score, the worse the functional status. The range is 0% to 100%."}, {'measure': 'The Clinical Impression of Severity Index - PD (CISI-PD).', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'Change from baseline in The Clinical Impression of Severity Index PD (CISI-PD). The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled); the possible scores range from 0 to 24. A total score is calculated by summing the item scores. Higher scores indicate worse severity. A negative value of change means an improvement and a positive value of change means deterioration.'}, {'measure': "The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).", 'timeFrame': 'Change from Baseline to Week 20', 'description': "Change from baseline in the Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). The PDQ-39 is a self-administered questionnaire of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. It is scored on a scale of 0 -100 with lower scores indicating better health and high scores indicating more severe symptoms."}, {'measure': 'The Geriatric Depression Scale-15 (GDS-15).', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'Change from baseline in the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item yes/no questionnaire of depression in older adults. Each depressive answer is 1 point. The final score is the tally of the number of depressive answers with the following scores indicating depression: 0-4 No depression; 5-10 Suggestive of a mild depression; 11 + Suggestive of severe depression. The possible scores range from 0 - 15.'}, {'measure': 'The Digital Clock Drawing Test (dCDT).', 'timeFrame': 'Change from Baseline to Week 20', 'description': "Change from baseline in the digital clock drawing test (dCDT). The pen-like dCDT device will be used to gather the x-y coordinates that describe the movement of the stylus as it changes its position during the assessment. It also assesses when the stylus or writing device is not exerting pressure on the writing surface. The dCDT score is a number from 0 and 100 that represents a person's overall cognitive function as assessed by DCT clock. The total possible score is 100. A negative value of change means a deterioration and a positive value of change means an improvement."}, {'measure': 'Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.', 'timeFrame': 'Change from Baseline to Week 20', 'description': 'The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores:\n\n* Power of Attention: Min: 350 ms ; Max: 60000 ms\n* Cognitive Reaction Time: Min: - 30000 ms; Max : 30000 ms\n* Speed of Memory: Min 800 ms; Max: 120000 ms\n\nHigher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Neurodegenerative Diseases', 'Neurocognitive Disorders', 'Mental Disorders', "Parkinson's Disease", 'Dementia'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.", 'detailedDescription': "This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.\n* Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria.\n* Score on the Montreal Cognitive Assessment (MoCA) of 13-25.\n* Modified Hoehn and Yahr Stages 1-4.\n* Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.\n\nExclusion Criteria:\n\n* History of blood coagulation disorders or hypercoagulability.\n* Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.\n* Prior hypersensitivity reaction to any human blood product or any IV infusion.\n* Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.\n* History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.\n* Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing\n* Hemoglobin \\< 10 g/dL in women and \\< 11 g/dL in men."}, 'identificationModule': {'nctId': 'NCT03713957', 'briefTitle': "A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment", 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkahest, Inc.'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment", 'orgStudyIdInfo': {'id': 'Alkahest study 6021-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GRF6021', 'description': 'Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.', 'interventionNames': ['Drug: GRF6021']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GRF6021', 'type': 'DRUG', 'description': 'GRF6021 for IV infusion', 'armGroupLabels': ['GRF6021']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo for IV infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Trials, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Movement Disorders Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33166', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Moonshine Research Center', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '32132', 'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'facility': 'Riverside Clinical Research', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Clinical', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America, LLC', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps_Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Quest Research Institute', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '48170', 'city': 'Plymouth', 'state': 'Michigan', 'country': 'United States', 'facility': 'SRI Biosciences', 'geoPoint': {'lat': 42.37143, 'lon': -83.47021}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'PsychCare Consultants Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Studies, INC.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hopital Neurologique', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Purpan - Hopital Pierre Paul Riquet', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Alkahest Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkahest, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkahest, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}