Trials / Completed
CompletedNCT03713957
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Alkahest, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GRF6021 | GRF6021 for IV infusion |
| OTHER | Placebo | Placebo for IV infusion |
Timeline
- Start date
- 2018-11-12
- Primary completion
- 2020-07-20
- Completion
- 2020-07-20
- First posted
- 2018-10-22
- Last updated
- 2022-05-09
- Results posted
- 2022-05-09
Locations
29 sites across 3 countries: United States, Australia, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03713957. Inclusion in this directory is not an endorsement.