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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663936
• Other study ID #: AA4437420
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2008
• Last updated: October 9, 2013
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: Toyama Chemical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• T-817MA
224 mg T-817 MA once daily
• Placebo
Placebo once daily

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	St. John	New Brunswick
Canada	Toronto Memory Program	Toronto	Ontario
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	NeuroPsychiatric Center of the Palm Beaches	Boynton Beach	Florida
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	SPRI Clinical Trials	Brooklyn	New York
United States	The Alzheimer's Memory Center	Charlotte	North Carolina
United States	Columbus Research & Wellness Institute	Columbus	Georgia
United States	Radiant Research	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Geriatric and Adult Psychiatry, LCC	Hamden	Connecticut
United States	Agewell	Indianapolis	Indiana
United States	The Clinical Trials Center	Jenkintown	Pennsylvania
United States	Cleveland Clinic - Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Galiz Research	Miami Springs	Florida
United States	Anchor Research Center	Naples	Florida
United States	Research Center for Clinical Studies, Inc.	Norwalk	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Southwest Institute for Clinical Research, Inc.	Rancho Mirage	California
United States	Alzheimer's Disease Center, U. of Rochester Medical Center	Rochester	New York
United States	Innovative Clinical Trials	San Antonio	Texas
United States	Pacific Research Network, Inc.	San Diego	California
United States	San Francisco Clinical Research Center	San Francisco	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute	Tampa	Florida
United States	Memory Enhancement Center of America	Toms River	New Jersey
United States	Northwest NeuroSpecialists	Tucson	Arizona
United States	IPC Research	Waukesha	Wisconsin
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Clinical Trials of America, Inc.	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Toyama Chemical Co., Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No