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

Sponsor:	Toyama Chemical Co., Ltd.
Information provided by:	Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00663936

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: T-817MA Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Further study details as provided by Toyama Chemical Co., Ltd.:

Primary Outcome Measures:

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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	326
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental T-817MA once daily	Drug: T-817MA 224 mg T-817 MA once daily
2: Placebo Comparator Placebo once daily	Drug: Placebo Placebo once daily

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663936

Contacts

Contact: Jeremy Johnston

1-800-554-0502 ext 294

JJohnston@incresearch.com

Show 29 Study Locations

Sponsors and Collaborators

Toyama Chemical Co., Ltd.

More Information

Additional Information:

Please click here to visit the study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Toyama Chemical Co., Ltd. ( Dr. Katsumi Shimizu, Development Management Department )
Study ID Numbers:	AA4437420
Study First Received:	April 18, 2008
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00663936 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Toyama Chemical Co., Ltd.:

Alzheimer's Disease
Alzheimer's

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 09, 2009