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

Phase 2

Completed

Brief 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).

Recruitment & Eligibility

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®)

Arm && Interventions

Group	Intervention	Description
T-817MA-L	T-817MA-L	224 mg T-817MA once daily
Placebo	Placebo	Placebo once daily
T-817MA-H	T-817MA-H	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.

Primary Outcome Measures

Name	Time	Method
ADAS-cog Change From Baseline to Week 52	Baseline and 52 weeks	The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).
CGIC	52 weeks	The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.

Secondary Outcome Measures

Name	Time	Method
ADCS-ADL Change From Baseline to Week 52	Baseline and 52 weeks	The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.

Locations (50): Banner Alzheimer's Institute
🇺🇸
Phoenix, Arizona, United States
Banner Sun Health Research Institute
🇺🇸
Sun City, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸
Tucson, Arizona, United States
Neurology Center of North Orange County
🇺🇸
Fullerton, California, United States
UCSD Comprehensive Alzheimer's Program
🇺🇸
La Jolla, California, United States
UC Irvine Medical Center
🇺🇸
Orange, California, United States
Geriatric and Adult Psychiatry, LCC
🇺🇸
Hamden, Connecticut, United States
Yale University, Alzheimer's Disease Research Unit
🇺🇸
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
🇺🇸
Norwalk, Connecticut, United States
Georgetown University Clinical Research Unit
🇺🇸
Washington, District of Columbia, United States
Scroll for more (40 remaining)
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States