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

Alkahest

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Other: Placebo; Drug: GRF6021

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03713957

Alkahest study 6021-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 79 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups, including a placebo group

GRF6021

Experimental group

Description:

Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.

Treatment:

Drug: GRF6021

Placebo

Placebo Comparator group

Description:

Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.

Treatment:

Other: Placebo