CompletedPhase 2

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

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

Lead sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Asset

T-817MA

Listed sites

Recruiting sites

Enrollment

373

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAA4437420

NCT IDNCT00663936

Timeline

Milestones

Study start2008-04 (month precision)

Study first posted2008-04-22estimated

Primary completion2011-05actual (month precision)

Study completion2011-06actual (month precision)

Last update posted2013-11-05estimated

Assets

Drug assets

T-817MA

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Male or female (post-menopausal or surgically sterile)

2. Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil.

3. Age 50 to 90 inclusive

4. Patients must be living in the community

5. Patients must have an eligible informant or study partner (caregiver)

6. Patients and eligible informant or study partner (caregiver) must be able to read and understand English.

7. Informed consent obtained from both the patient and the caregiver etc (According to the protocol)

Exclusion criteria

1. Patients with clinically significant cardiac, hepatic or renal impairment

2. Patient have a dementia not of the Alzheimer's type etc (According to the protocol)

3. Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Global cognition

1 endpoint

Primary/protocol endpoint

Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.

Time frame:52 weeks

ADAS-Cog

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.

Time frame:52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.