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Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

NCT02079909 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2019-02-26

Study results available
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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).

Conditions

Interventions

DRUG

T-817MA-H

224 mg or 448 mg T-817 MA once daily

DRUG

T-817MA-L

224 mg T-817 MA once daily

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

    collaborator OTHER

  • FUJIFILM Toyama Chemical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-05-05
Completion
2017-05-05

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079909 on ClinicalTrials.gov