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Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02079909
First Posted: March 6, 2014
Last Update Posted: May 17, 2017
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.
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Toyama Chemical Co., Ltd.
  Purpose

The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC.

The secondary objectives are:

  • To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events.
  • To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).

Condition Intervention Phase
Alzheimer's Disease Drug: T-817MA-H Drug: T-817MA-L Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC. [ Time Frame: Time Frame 52 weeks ]

Secondary Outcome Measures:
  • Clinical Safety [ Time Frame: 56 weeks ]
    To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events.

  • Efficacy [ Time Frame: 56 weeks ]
    To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).


Enrollment: 484
Study Start Date: March 2014
Study Completion Date: May 5, 2017
Primary Completion Date: May 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T-817MA-H
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
Drug: T-817MA-H
224 mg or 448 mg T-817 MA once daily
Experimental: T-817MA-L
224 mg T-817MA once daily
Drug: T-817MA-L
224 mg T-817 MA once daily
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.
  • Age 55 to 85 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

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 or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)
  Contacts and Locations
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): NCT02079909


  Show 50 Study Locations
Sponsors and Collaborators
Toyama Chemical Co., Ltd.
Alzheimer's Disease Cooperative Study (ADCS)
  More Information

Additional Information:
Responsible Party: Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02079909     History of Changes
Other Study ID Numbers: T817MAUS202
First Submitted: March 4, 2014
First Posted: March 6, 2014
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Toyama Chemical Co., Ltd.:
Alzheimer's Disease
Alzheimer's

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders