- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03713957
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3004
- Alfred Hospital
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Bron, France, 69677
- Hôpital Neurologique
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Creteil, France, 94000
- Hopital Henri Mondor
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Grenoble, France, 38043
- Chu Grenoble Alpes
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Lille, France, 59000
- Hôpital Roger Salengro
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Marseille, France, 13385
- Hopital De La Timone
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Nimes, France, 30029
- CHU Carémeau
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Poitiers, France, 86021
- CHU de Poitiers
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Rouen, France, 76000
- CHU Charles Nicolle
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Toulouse, France, 31059
- CHU Purpan - Hopital Pierre Paul Riquet
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Clinical Trials, Inc.
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Colorado
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Englewood, Colorado, United States, 80113
- Rocky Mountain Movement Disorders Center
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Florida
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Doral, Florida, United States, 33166
- Moonshine Research Center
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Edgewater, Florida, United States, 32132
- Riverside Clinical Research
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Hallandale Beach, Florida, United States, 33009
- MD Clinical
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Hollywood, Florida, United States, 33024
- Research Centers of America, LLC
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Miami, Florida, United States, 33135
- Suncoast Research Group, LLC
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South Miami, Florida, United States, 33143
- Qps_Mra, Llc
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Georgia
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Atlanta, Georgia, United States, 30331
- Atlanta Center for Medical Research
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Atlanta, Georgia, United States, 30342
- NeuroTrials Research Inc.
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Michigan
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Farmington Hills, Michigan, United States, 48334
- Quest Research Institute
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Plymouth, Michigan, United States, 48170
- SRI Biosciences
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Missouri
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Saint Louis, Missouri, United States, 63128
- PsychCare Consultants Research
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North Carolina
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Raleigh, North Carolina, United States, 27612
- Wake Research
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Houston, Texas, United States, 77058
- Centex Studies, Inc.
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Washington
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Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.
- 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.
- Score on the Montreal Cognitive Assessment (MoCA) of 13-25.
- Modified Hoehn and Yahr Stages 1-4.
- Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.
Exclusion Criteria:
- History of blood coagulation disorders or hypercoagulability.
- Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
- Prior hypersensitivity reaction to any human blood product or any IV infusion.
- Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
- History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.
- Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing
- Hemoglobin < 10 g/dL in women and < 11 g/dL in men.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GRF6021
Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
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GRF6021 for IV infusion
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Placebo Comparator: Placebo
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
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Placebo for IV infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Approximately 24 Months
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Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
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Approximately 24 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Montreal Cognitive Assessment (MoCA) Score.
Time Frame: Change from Baseline to Week 16
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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)].
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Change from Baseline to Week 16
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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.
Time Frame: Change from Baseline to Week 20
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The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores:
Note: # denotes "no specific unit" Lower 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. |
Change from Baseline to Week 20
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The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.
Time Frame: Change from Baseline to Week 20
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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.
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Change from Baseline to Week 20
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The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.
Time Frame: Change from Baseline to Week 16
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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.
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Change from Baseline to Week 16
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The Schwab and England Activities of Daily Living (SE-ADL) Scale.
Time Frame: Change from Baseline to Week 24
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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%.
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Change from Baseline to Week 24
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The Clinical Impression of Severity Index - PD (CISI-PD).
Time Frame: Change from Baseline to Week 24
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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.
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Change from Baseline to Week 24
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The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).
Time Frame: Change from Baseline to Week 20
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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.
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Change from Baseline to Week 20
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The Geriatric Depression Scale-15 (GDS-15).
Time Frame: Change from Baseline to Week 20
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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.
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Change from Baseline to Week 20
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The Digital Clock Drawing Test (dCDT).
Time Frame: Change from Baseline to Week 20
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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.
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Change from Baseline to Week 20
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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.
Time Frame: Change from Baseline to Week 20
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The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores:
Higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline. |
Change from Baseline to Week 20
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alkahest study 6021-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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