Study of LM11A-31-BHS in Mild-moderate AD Patients

Mild to Moderate Alzheimer's Disease Clinical Trial

Official title: A 6-months Prospective, Multi-center, Double-blind, Placebo-controlled, Randomized, Adaptive-trial-design Study to Evaluate Safety, Tolerability and Exploratory Endpoints of Either Placebo or Two Different Oral Doses of LM11A-31-BHS in Patients With Mild to Moderate Probable Alzheimer's Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180 patients with Alzheimer's Disease versus placebo and to access biomarker and clinical exploratory endpoints of LM11A-31-BHS

Clinical Trial Description

The goal of this AD Pilot is to conduct a prospective, double-blind, multicenter, phase IIa exploratory safety, feasibility and proof-of-concept trial in mild to moderate Alzheimer's disease patients with the orally bioavailable p75 neurotrophin receptor ligand LM11A-31-BHS dosed twice daily for 26 weeks. Successful completion of this trial will provide the safety, endpoint and statistical basis for the design and execution of a phase 2b/3 efficacy trial. It will also bring to the AD field a much-needed new set of target mechanisms and will help pioneer the strategy of the concomitant targeting of multiple fundamental AD-related pathological processes.

During the 26 weeks study period the eligible patients will be invited to 5 visits.

Safety monitoring will include the full extent of phase 2 clinical, electrophysiological and laboratory testing. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild to Moderate Alzheimer's Disease

• NCT number: NCT03069014
• Study type: Interventional
• Source: PharmatrophiX Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 15, 2017
• Completion date: June 8, 2020