Clinical trial NCT00663936: Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Alzheimer's
Lead sponsor: FUJIFILM Toyama Chemical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 373
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 52 weeks
Secondary outcomes:
measure: 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.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists
state: Arizona
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Southwest Institute for Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc.
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Hamden
country: United States
facility: Geriatric and Adult Psychiatry, LCC
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Boynton Beach
country: United States
facility: NeuroPsychiatric Center of the Palm Beaches
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Columbus
country: United States
facility: Columbus Research & Wellness Institute
state: Georgia
city: Indianapolis
country: United States
facility: Agewell
state: Indiana
city: Las Vegas
country: United States
facility: Cleveland Clinic - Lou Ruvo Center for Brain Health
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Toms River
country: United States
facility: Memory Enhancement Center of America
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials
state: New York
city: Rochester
country: United States
facility: Alzheimer's Disease Center, U. of Rochester Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Charlotte
country: United States
facility: The Alzheimer's Memory Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston Salem
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Jenkintown
country: United States
facility: The Clinical Trials Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Waukesha
country: United States
facility: IPC Research
state: Wisconsin
city: St. John
country: Canada
facility: St. Joseph's Hospital
state: New Brunswick
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
Study officials:
References: