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

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT03713957

Run by

Alkahest, Inc.

People needed

79

Starts

2018-11-12

Expected to finish

2020-07-20

Last updated by the study team

2022-05-09

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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