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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663936

Enrollment

373

Registered

2008-04-22

Start date

2008-04-30

Completion date

2011-06-30

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, Alzheimer's

Brief summary

The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the 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.

Interventions

DRUGT-817MA

224 mg T-817 MA once daily

DRUGPlacebo

Placebo once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
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.	52 weeks

Secondary

Measure	Time frame
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.	52 weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026