CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 482 enrolled
Drug / intervention
T-817MA-H +2 moredrug
Likely dose
T-817MA-H 224 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02079909
NCT02079909Phase 2Completed
CompareCT.gov

A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

FUJIFILM Toyama Chemical Co., Ltd.·interventional·Posted Mar 6, 2014·Updated Feb 26, 2019

In Brief

A Phase 2 clinical trial evaluating T-817MA-H, T-817MA-L, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 482 participants across 50 sites.

Detailed Summary

The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC. The secondary objectives are: * To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events. * To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsAlzheimer's Disease Cooperative Study (ADCS)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 6, 2014
Enrollment StartMar 1, 2014
Primary CompletionMay 5, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.3 years ago

Interventions

T-817MA-Hdrug

224 mg or 448 mg T-817 MA once daily

T-817MA-Ldrug

224 mg T-817 MA once daily

Placebodrug

Placebo