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Trial record 2 of 2 for:    GRF6021

A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03713957
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Alkahest, Inc.

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Incidence of treatment-emergent adverse events (safety) [ Time Frame: Baseline to 7 months ]
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2018)
  • The Montreal Cognitive Assessment (MoCA) score. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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. A score of 26 and over is considered normal, compared to 22.1 in people with mild cognitive impairment.
  • The Continuity and Power of Attention, 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: Baseline to 7 months ]
    Change from baseline in the CDR-CCB. The CDR-CCB is an automated cognitive function assessment which will be used to assess: Continuity and Power of Attention, Working Memory, and Episodic Memory.
  • The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
  • The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and total score. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
  • The Schwab and England Activities of Daily Living (SE-ADL) Scale. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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 Clinical Impression of Severity Index - PD (CISI-PD). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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). A total score is calculated by summing the item scores.
  • The PD Quality of Life Questionnaire-39 (PDQ-39). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
  • The Geriatric Depression Scale-15 (GDS-15). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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 digital clock drawing test (dCDT). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • The Montreal Cognitive Assessment (MoCA) score. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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. A score of 26 and over is considered normal, compared to 22.1 in people with mild cognitive impairment.
  • The Continuity and Power of Attention, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the CDR-CCB. The CDR-CCB is an automated cognitive function assessment which will be used to assess: Continuity and Power of Attention, Working Memory, and Episodic Memory.
  • The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
  • The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and total score. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
  • The Schwab and England Activities of Daily Living (SE-ADL) Scale. [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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 Clinical Impression of Severity Index - PD (CISI-PD). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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). A total score is calculated by summing the item scores.
  • The PD Quality of Life Questionnaire-39 (PDQ-39). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
  • The Geriatric Depression Scale-15 (GDS-15). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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 digital clock drawing test (dCDT). [ Time Frame: Baseline to 7 months ]
    Change from baseline in the 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Official Title  ICMJE 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
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: GRF6021
    GRF6021 for IV infusion
  • Other: Placebo
    Placebo for IV infusion
Study Arms  ICMJE
  • Experimental: GRF6021
    Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
    Intervention: Drug: GRF6021
  • Placebo Comparator: Placebo
    Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2020)
79
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
90
Actual Study Completion Date  ICMJE July 20, 2020
Actual Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713957
Other Study ID Numbers  ICMJE Alkahest study 6021-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkahest, Inc.
Study Sponsor  ICMJE Alkahest, Inc.
Collaborators  ICMJE Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE
Study Director: Alkahest Medical Monitor Alkahest, Inc.
PRS Account Alkahest, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP