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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03713957




Registration number
NCT03713957
Ethics application status
Date submitted
18/10/2018
Date registered
22/10/2018
Date last updated
9/05/2022

Titles & IDs
Public title
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Scientific title
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
Secondary ID [1] 0 0
Alkahest study 6021-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GRF6021
Other interventions - Placebo

Experimental: GRF6021 - Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.

Placebo comparator: Placebo - Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.


Treatment: Drugs: GRF6021
GRF6021 for IV infusion

Other interventions: Placebo
Placebo for IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Approximately 24 Months
Secondary outcome [1] 0 0
The Montreal Cognitive Assessment (MoCA) Score.
Timepoint [1] 0 0
Change from Baseline to Week 16
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Change from Baseline to Week 20
Secondary outcome [3] 0 0
The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.
Timepoint [3] 0 0
Change from Baseline to Week 20
Secondary outcome [4] 0 0
The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.
Timepoint [4] 0 0
Change from Baseline to Week 16
Secondary outcome [5] 0 0
The Schwab and England Activities of Daily Living (SE-ADL) Scale.
Timepoint [5] 0 0
Change from Baseline to Week 24
Secondary outcome [6] 0 0
The Clinical Impression of Severity Index - PD (CISI-PD).
Timepoint [6] 0 0
Change from Baseline to Week 24
Secondary outcome [7] 0 0
The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).
Timepoint [7] 0 0
Change from Baseline to Week 20
Secondary outcome [8] 0 0
The Geriatric Depression Scale-15 (GDS-15).
Timepoint [8] 0 0
Change from Baseline to Week 20
Secondary outcome [9] 0 0
The Digital Clock Drawing Test (dCDT).
Timepoint [9] 0 0
Change from Baseline to Week 20
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Change from Baseline to Week 20

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2020
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
France
State/province [12] 0 0
Bron
Country [13] 0 0
France
State/province [13] 0 0
Creteil
Country [14] 0 0
France
State/province [14] 0 0
Grenoble
Country [15] 0 0
France
State/province [15] 0 0
Lille
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Nimes
Country [18] 0 0
France
State/province [18] 0 0
Poitiers
Country [19] 0 0
France
State/province [19] 0 0
Rouen
Country [20] 0 0
France
State/province [20] 0 0
Toulouse

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alkahest, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Michael J. Fox Foundation for Parkinson's Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03713957
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alkahest Medical Monitor
Address 0 0
Alkahest, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03713957