NCT03765762

A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Pulsed GRF6019 Infusions in Subjects With Severe Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alkahest, Inc. · Industry
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.

Detailed description

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability and potential cognitive benefit of GRF6019, a human plasma protein fraction. GRF6019 or placebo will be administered intravenously to subjects with severe Alzheimer's disease every day for 5 consecutive days. The total study duration for each subject is approximately 9 weeks.

Conditions

• Severe Alzheimer Disease

Interventions

Type	Name	Description
DRUG	GRF6019	GRF6019 for IV infusion
OTHER	Placebo	Placebo for IV infusion

Timeline

• Start date: 2019-01-15
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2018-12-05
• Last updated: 2021-01-27
• Results posted: 2021-01-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study