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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: T-817MA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (post-menopausal or surgically sterile) Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil. Age 50 to 90 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 etc (According to the protocol) 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 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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>T-817MA once daily | Drug: T-817MA<br>* 224 mg T-817 MA once daily<br>|
| Placebo Comparator: 2<br>Placebo once daily | Drug: Placebo<br>* Placebo once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Alzheimer's