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



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 85
Updated:2/23/2019
Start Date:November 12, 2018
End Date:November 2020
Contact:Alkahest Clinical Trials
Email:trials@alkahest.com
Phone:650-801-0474

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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

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.

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.

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, haptoglobin, or C1 inhibitor 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.
We found this trial at
9
sites
2128 W Flagler St # 201
Miami, Florida 33144
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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Atlanta, GA
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Edgewater, Florida 32132
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Farmington Hills, Michigan 48334
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Hallandale Beach, Florida 33009
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Hallandale Beach, FL
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7261 Sheridan Street
Hollywood, Florida 33024
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Hollywood, FL
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Houston, Texas 77062
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Houston, TX
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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Raleigh, NC
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