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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00663936
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
FUJIFILM Toyama Chemical Co., Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: T-817MA Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
T-817MA once daily
 Drug: T-817MA
224 mg T-817 MA once daily
Placebo Comparator: 2
Placebo once daily
 Drug: Placebo
Placebo once daily


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  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. [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663936


Locations
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Sponsors and Collaborators
FUJIFILM Toyama Chemical Co., Ltd.
More Information
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Responsible Party: FUJIFILM Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00663936    
Other Study ID Numbers: AA4437420
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: December 2012
Keywords provided by FUJIFILM Toyama Chemical Co., Ltd.:
Alzheimer's Disease
Alzheimer's
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders