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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: T-817MA; Drug: Placebo

• Registration Number: NCT00663936
• Lead Sponsor: FUJIFILM Toyama Chemical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-12
• Disposition First Submitted: 2012-12-09
• Disposition First Submitted QC: 2012-12-10
• Disposition First Posted: 2012-12-12
• Last Update Submitted: 2013-10-09
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	T-817MA	T-817MA once daily
2	Placebo	Placebo once daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (35)

Geriatric and Adult Psychiatry, LCC; 🇺🇸 Hamden, Connecticut, United States

NeuroPsychiatric Center of the Palm Beaches; 🇺🇸 Boynton Beach, Florida, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Pacific Research Network, Inc.; 🇺🇸 San Diego, California, United States

Cleveland Clinic - Lou Ruvo Center for Brain Health; 🇺🇸 Las Vegas, Nevada, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Innovative Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Toronto Memory Program; 🇨🇦 Toronto, Ontario, Canada

Southwest Institute for Clinical Research, Inc.; 🇺🇸 Rancho Mirage, California, United States

Northwest NeuroSpecialists; 🇺🇸 Tucson, Arizona, United States

Collaborative Neuroscience Network, Inc.; 🇺🇸 Garden Grove, California, United States

San Francisco Clinical Research Center; 🇺🇸 San Francisco, California, United States

Anchor Research Center; 🇺🇸 Naples, Florida, United States

Columbus Research & Wellness Institute; 🇺🇸 Columbus, Georgia, United States

Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Axiom Clinical Research of Florida; 🇺🇸 Tampa, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Agewell; 🇺🇸 Indianapolis, Indiana, United States

Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

SPRI Clinical Trials; 🇺🇸 Brooklyn, New York, United States

Brooklyn Medical Institute; 🇺🇸 Brooklyn, New York, United States

Alzheimer's Disease Center, U. of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Richmond Behavioral Associates; 🇺🇸 Staten Island, New York, United States

IPC Research; 🇺🇸 Waukesha, Wisconsin, United States

Raleigh Neurology Associates; 🇺🇸 Raleigh, North Carolina, United States

Clinical Trials of America, Inc.; 🇺🇸 Winston Salem, North Carolina, United States

CRI Worldwide, LLC; 🇺🇸 Philadelphia, Pennsylvania, United States

The Clinical Trials Center; 🇺🇸 Jenkintown, Pennsylvania, United States

St. Joseph's Hospital; 🇨🇦 St. John, New Brunswick, Canada

Comprehensive Clinical Research; 🇺🇸 Berlin, New Jersey, United States

Research Center for Clinical Studies, Inc.; 🇺🇸 Norwalk, Connecticut, United States

Galiz Research; 🇺🇸 Miami Springs, Florida, United States

Memory Enhancement Center of America; 🇺🇸 Toms River, New Jersey, United States

The Alzheimer's Memory Center; 🇺🇸 Charlotte, North Carolina, United States

Radiant Research; 🇺🇸 Denver, Colorado, United States