drugset / Trial / NCT03117738

A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease

NCT03117738 ↗

Phase 1/2 Completed 21 enrolled Nature Cell Co. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.

Timeline

Start
2017-05-09
Primary completion
2019-06-26
Completion
2019-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject AstroStem Cell therapy — Intravenous

Indications