Efficacy and Safety of MMFS in Early AD

Alzheimer Disease Clinical Trial

Official title: Clinical Trial to Test the Efficacy and Safety of MMFS-205 in Early Alzheimer's Disease Patients

Status Completed

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of MMFS for improving cognition and global function in patients with probable Early Alzheimer's disease.

Clinical Trial Description

This is a phase 2 study in patients with probable Early Alzheimer's disease (AD). Early AD includes Stage 3 AD patients (MCI due to AD) and Stage 4 AD patients (mild AD). The study is a randomized, double-blind, placebo controlled, parallel group design, in which participants (up to 6 per arm; 12 total) will receive oral placebo or MMFS twice daily for 24 weeks. Randomized patients and their informants (required) will complete 3 assessments total: at baseline (prior to taking any study tablets), week 12, and week 24 visits. At each of the three visits, participants will complete cognitive and behavioral measures and clinical interviews, a blood sample will be collected for safety and biomarkers related to Alzheimer's disease, and the informant will complete an interview concerning the patient's cognition, mood, and function. A range of safety and tolerability assessments will also be performed (including vital signs, laboratory tests, and ECGs). Participants will be contacted by phone between clinical assessments for monitoring. ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT03531684
• Study type: Interventional
• Source: Neurocentria, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: March 20, 2018
• Completion date: April 22, 2020