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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 May 2022 |
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Main ID: |
NCT03713957 |
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Date of registration:
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18/10/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
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Scientific title:
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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 |
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Date of first enrolment:
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November 12, 2018 |
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Target sample size:
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79 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03713957 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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France
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United States
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Contacts
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Name:
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Alkahest Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alkahest, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: GRF6021
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Other: Placebo
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Primary Outcome(s)
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Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
[Time Frame: Approximately 24 Months]
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Secondary Outcome(s)
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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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The Digital Clock Drawing Test (dCDT).
[Time Frame: 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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The Montreal Cognitive Assessment (MoCA) Score.
[Time Frame: 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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The Clinical Impression of Severity Index - PD (CISI-PD).
[Time Frame: Change from Baseline to Week 24]
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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 Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.
[Time Frame: Change from Baseline to Week 20]
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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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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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Secondary ID(s)
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Alkahest study 6021-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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