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

• Status: Completed
• Trial end date: 2020-07-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkahest, Inc.
• Collaborator: Michael J. Fox Foundation for Parkinson's Research

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.