A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
NCT ID: NCT03713957
Last Updated: 2022-05-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2018-11-12
2020-07-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
NCT02565628
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
NCT02373072
Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
NCT02006290
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
NCT04777331
BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations
NCT03608371
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GRF6021
Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
GRF6021
GRF6021 for IV infusion
Placebo
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
Placebo
Placebo for IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GRF6021
GRF6021 for IV infusion
Placebo
Placebo for IV infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Michael J. Fox Foundation for Parkinson's Research
OTHER
Alkahest, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alkahest Medical Monitor
Role: STUDY_DIRECTOR
Alkahest, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States
Moonshine Research Center
Doral, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
MD Clinical
Hallandale, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Qps_Mra, Llc
South Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
Quest Research Institute
Farmington Hills, Michigan, United States
SRI Biosciences
Plymouth, Michigan, United States
PsychCare Consultants Research
St Louis, Missouri, United States
Wake Research
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Centex Studies, INC.
Houston, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Alfred Hospital
Melbourne, Victoria, Australia
Hopital Neurologique
Bron, , France
Hopital Henri Mondor
Créteil, , France
CHU Grenoble Alpes
Grenoble, , France
Hopital Roger Salengro
Lille, , France
Hopital de la Timone
Marseille, , France
CHU Caremeau
Nîmes, , France
CHU de Poitiers
Poitiers, , France
CHU Charles Nicolle
Rouen, , France
CHU Purpan - Hopital Pierre Paul Riquet
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Alkahest study 6021-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.