Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
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
1 other identifier
interventional
373
2 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
Typical duration for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 5, 2013
December 1, 2012
3.1 years
April 18, 2008
October 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALT-817MA once daily
2
PLACEBO COMPARATORPlacebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Northwest NeuroSpecialists
Tucson, Arizona, 85741, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Southwest Institute for Clinical Research, Inc.
Rancho Mirage, California, 92270, United States
Pacific Research Network, Inc.
San Diego, California, 92103, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Radiant Research
Denver, Colorado, 80239, United States
Geriatric and Adult Psychiatry, LCC
Hamden, Connecticut, 06518, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851, United States
NeuroPsychiatric Center of the Palm Beaches
Boynton Beach, Florida, 33426, United States
Galiz Research
Miami Springs, Florida, 33166, United States
Anchor Research Center
Naples, Florida, 34102, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
Tampa, Florida, 33613, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Columbus Research & Wellness Institute
Columbus, Georgia, 31907, United States
Agewell
Indianapolis, Indiana, 46260, United States
Cleveland Clinic - Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Memory Enhancement Center of America
Toms River, New Jersey, 08755, United States
Brooklyn Medical Institute
Brooklyn, New York, 11214, United States
SPRI Clinical Trials
Brooklyn, New York, 11235, United States
Alzheimer's Disease Center, U. of Rochester Medical Center
Rochester, New York, 14620, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
The Alzheimer's Memory Center
Charlotte, North Carolina, 28211, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, 27103, United States
The Clinical Trials Center
Jenkintown, Pennsylvania, 19046, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
IPC Research
Waukesha, Wisconsin, 53188, United States
St. Joseph's Hospital
Saint John, New Brunswick, E2L 3L6, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 22, 2008
Study Start
April 1, 2008
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
November 5, 2013
Record last verified: 2012-12