Status:
COMPLETED
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
FUJIFILM Toyama Chemical Co., Ltd.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00663936
Start Date
April 1 2008
End Date
June 1 2011
Last Update
November 5 2013
Active Locations (35)
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1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
Northwest NeuroSpecialists
Tucson, Arizona, United States, 85741
3
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
4
Southwest Institute for Clinical Research, Inc.
Rancho Mirage, California, United States, 92270