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

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: 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.

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 6, 2014
Results First Submitted Date  ICMJE May 7, 2018
Results First Posted Date  ICMJE August 9, 2018
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE March 2014
Actual Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: T-817MA-H
    224 mg or 448 mg T-817 MA once daily
  • Drug: T-817MA-L
    224 mg T-817 MA once daily
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: T-817MA-H
  • Experimental: T-817MA-L
    224 mg T-817MA once daily
    Intervention: Drug: T-817MA-L
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: Placebo
Publications * Schneider LS, Thomas RG, Hendrix S, Rissman RA, Brewer JB, Salmon DP, Oltersdorf T, Okuda T, Feldman HH; Alzheimer's Disease Cooperative Study TCAD Study Group. Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2019 Nov 1;76(11):1330-1339. doi: 10.1001/jamaneurol.2019.1868.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2018)
482
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
450
Actual Study Completion Date  ICMJE May 5, 2017
Actual Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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®)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02079909
Other Study ID Numbers  ICMJE T817MAUS202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FUJIFILM Toyama Chemical Co., Ltd.
Study Sponsor  ICMJE FUJIFILM Toyama Chemical Co., Ltd.
Collaborators  ICMJE Alzheimer's Disease Cooperative Study (ADCS)
Investigators  ICMJE Not Provided
PRS Account FUJIFILM Toyama Chemical Co., Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP