Clinical Trial 42913

share

Atlanta, GA 30342


Study 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.


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.


Qualified Participants May Receive:

Compensation for time and travel for all completed study visits if qualified.


Study is Available At:

NeuroTrials Research
1100 Johnson Ferry Road NW suite 420
Atlanta, GA 30342
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.