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Trial record 2 of 7 for:    alkahest

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

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ClinicalTrials.gov Identifier: NCT03713957
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Alkahest, Inc.

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: GRF6021 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GRF6021
Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
Drug: GRF6021
GRF6021 for IV infusion

Placebo Comparator: Placebo
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
Other: Placebo
Placebo for IV infusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713957


Contacts
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Contact: Alkahest Clinical Trials 650-801-0474 trials@alkahest.com

Locations
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United States, Arkansas
Clinical Trials, Inc. Recruiting
Little Rock, Arkansas, United States, 72205
Contact: - Lauren Landers       llanders@clinicaltrialsinc.com   
United States, Colorado
Rocky Mountain Movement Disorders Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Scott Rubinstein       srubinstein@kumarneuro.com   
United States, Florida
Moonshine Research Center Recruiting
Doral, Florida, United States, 33166
Contact: Ana Pimentel       APimentel@moonshineclinicalresearch.com   
Riverside Clinical Research Recruiting
Edgewater, Florida, United States, 32132
Contact: Shatara Bivins       sbivins@riversideclinicalresearch.com   
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: Evelyn Quiles       equiles@mdclinical.org   
Research Centers of America, LLC Recruiting
Hollywood, Florida, United States, 33024
Contact: Gisela Cortina       gisela.cortina@rcatrials.com   
Suncoast Research Group, LLC Recruiting
Miami, Florida, United States, 33135
Contact: Richard Garcia       rgarcia@suncoastresearch.com   
Qps_Mra, Llc Recruiting
South Miami, Florida, United States, 33143
Contact: Steven Galvez       Steven.Galvez@qps.com   
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
Contact: Savannah Erickson       SErickson@acmr.org   
NeuroTrials Research Inc. Recruiting
Atlanta, Georgia, United States, 30342
Contact: Tim Thurman       tthurman@neurotrials.com   
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Christina Michael       christina@questri.com   
United States, North Carolina
Wake Research Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Michael O'Brien       mobrien@wakeresearch.com   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Agazit Tecle       teclea@ccf.org   
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Susan Bonner       bonnesu@ohsu.edu   
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Giselle Huet       Giselle.huet@utsouthwestern.edu   
Centex Studies, INC. Recruiting
Houston, Texas, United States, 77058
Contact: Shannon Moyer       smoyer@centexstudies.com   
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Alkahest, Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
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Study Director: Alkahest Medical Monitor Alkahest, Inc.

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Responsible Party: Alkahest, Inc.
ClinicalTrials.gov Identifier: NCT03713957     History of Changes
Other Study ID Numbers: Alkahest study 6021-201
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkahest, Inc.:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Parkinson's Disease
Dementia
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders