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

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ClinicalTrials.gov Identifier: NCT02079909
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : August 9, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
FUJIFILM Toyama Chemical Co., Ltd.

Study Description
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Brief Summary:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
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
Study Start Date : March 2014
Actual Primary Completion Date : May 5, 2017
Actual Study Completion Date : May 5, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. ADAS-cog Change From Baseline to Week 52 [ Time Frame: Baseline and 52 weeks ]
    The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).

  2. CGIC [ Time Frame: 52 weeks ]
    The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.


Secondary Outcome Measures :
  1. ADCS-ADL Change From Baseline to Week 52 [ Time Frame: Baseline and 52 weeks ]
    The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
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
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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): NCT02079909


Locations
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Sponsors and Collaborators
FUJIFILM Toyama Chemical Co., Ltd.
Alzheimer's Disease Cooperative Study (ADCS)
  Study Documents (Full-Text)

Documents provided by FUJIFILM Toyama Chemical Co., Ltd.:
Study Protocol and Statistical Analysis Plan  [PDF] July 12, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: FUJIFILM Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02079909    
Other Study ID Numbers: T817MAUS202
First Posted: March 6, 2014    Key Record Dates
Results First Posted: August 9, 2018
Last Update Posted: February 26, 2019
Last Verified: February 2019
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