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CompletedPhase 2Results posted

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

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

Lead sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Asset

T-817MA

Listed sites

Recruiting sites

Enrollment

482

actual

Study population

Alzheimer’s disease

Key I/E criteria

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

Primary endpoints

•ADAS-Cog•CGIC

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

NCT IDNCT02079909

Org study IDT817MAUS202

Timeline

Milestones

Study start2014-03 (month precision)

Study first posted2014-03-06estimated

Primary completion2017-05-05actual

Study completion2017-05-05actual

Results first posted2018-08-09actual

Last update posted2019-02-26actual

Assets

Drug assets

T-817MA

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female (post-menopausal or surgically sterile)

•Patients with Mild to moderate Alzheimer's disease who are receiving donepezil (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.

•Age 55 to 85 inclusive

•Patients must be living in the community

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

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

•Informed consent obtained from both the patient and the caregiver

Exclusion criteria

•Patients with clinically significant cardiac, hepatic or renal impairment

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

•Patients who are taking any drug other than donepezil or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)

Endpoints (6)

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

Other clinical outcomes

Global cognition

2 endpoints

Primary/protocol endpoint

ADAS-cog Change From Baseline to Week 52

Time frame:Baseline and 52 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

ADAS-cog Change From Baseline to Week 52

Time frame:Baseline and 52 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
T-817MA-Hn=117 Participants	7.08	0.756
T-817MA-Ln=115 Participants	7.45	0.756
Placebon=137 Participants	7.91	0.727

Mean Difference (Final Values)-0.84p0.3919Mixed Models Analysis

Function / daily living

2 endpoints

Secondary/protocol endpoint

ADCS-ADL Change From Baseline to Week 52

Time frame:Baseline and 52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

ADCS-ADL Change From Baseline to Week 52

Time frame:Baseline and 52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
T-817MA-Hn=118 Participants	-10.01	0.991
T-817MA-Ln=118 Participants	-11.07	0.992
Placebon=140 Participants	-11.29	0.957

Mean Difference (Final Values)1.29p0.3212Mixed Models Analysis

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

CGIC

Time frame:52 weeks

change from baseline, improvement

Primary/registry result

CGIC

Time frame:52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
T-817MA-Hn=118 Participants	5.25	0.1
T-817MA-Ln=116 Participants	5.24	0.1
Placebon=138 Participants	5.22	0.1

Mean Difference (Final Values)0.04p0.7588Mixed Models Analysis

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Schneider LS, Thomas RG, Hendrix S, Rissman RA, Brewer JB, Salmon DP, Oltersdorf T, Okuda T, Feldman HH; Alzheimer's Disease Cooperative Study TCAD Study Group. Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2019 Nov 1;76(11):1330-1339. doi: 10.1001/jamaneurol.2019.1868.
PMID31282954via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.