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

  • STATUS
    Recruiting
Updated on 24 January 2020
cognitive impairment
dementia
movement disorder

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.

 

Details
Condition Parkinson's disease
Clinical Study IdentifierTX218034
Last Modified on24 January 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 85 yrs?
Gender: Male or Female
Do you have Parkinson's disease?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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