NCT03069014

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: PharmatrophiX Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Mild to Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	400mg LM11A-31-BHS	1 Oral Capsules (200mg of LM11A-31-BHS and 200mg of placebo) twice daily (morning \& evening) for 26 weeks
DRUG	800mg LM11A-31-BHS	2 Oral Capsules (200mg of LM11A-31-BHS) twice daily (morning \& evening) for 26 weeks
DRUG	Placebos	2 Oral Capsules (200mg of Placebo) twice daily (morning \& evening) for 26 weeks

Timeline

• Start date: 2017-02-15
• Primary completion: 2020-06-08
• Completion: 2020-06-08
• First posted: 2017-03-03
• Last updated: 2020-09-04

Locations

21 sites across 5 countries: Austria, Czechia, Germany, Spain, Sweden