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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T-817MA-H
T-817MA-L
Placebo
Sponsored by
FUJIFILM Toyama Chemical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Alzheimer's

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®)

Sites / Locations

  • Banner Alzheimer's Institute
  • Banner Sun Health Research Institute
  • University of Arizona Health Sciences Center
  • Neurology Center of North Orange County
  • UCSD Comprehensive Alzheimer's Program
  • UC Irvine Medical Center
  • Geriatric and Adult Psychiatry, LCC
  • Yale University, Alzheimer's Disease Research Unit
  • Research Center for Clinical Studies, Inc.
  • Georgetown University Clinical Research Unit
  • Infinity Clinical Research, LLC
  • University of Miami Miller-School of Medicine
  • Scientific Clinical Research, Inc
  • Renstar Medical Research
  • Meridien Research
  • Neuro Trials Research, Inc
  • Rush University Medical Center
  • SIU School of Medicine
  • Indiana Medical Research
  • Indiana University Health Partners, Adult Neurology Clinic
  • University of Iowa Hospitals and Clinics
  • University of Kansas/Clinical and Translational Science Unit
  • University of Kentucky Sanders-Brown Center on Aging Clinic
  • Pennington Biomedical Research Center
  • Acadia Hospital
  • Boston University Alzheimer's Disease Center
  • University of Michigan Health System/ Michigan Clinical Research Unit
  • Michigan State University
  • Bronson Neurobehvioral Health
  • University of Nebraska Medical Center(Geri Psych)
  • Cleveland Clinic Lou Ruvo Center for Brain Health
  • Global Medical Institutes, LLC;Princeton Medical Institute
  • Dent Neurologic Institute
  • Alzheimer's Disease Research Center of Mount Sinai
  • Columbia University Medical Center Sergievsky Center Taub Institute
  • The Nathan S. Kline Instituite for Psychiatric Research
  • University of Rochester Medical Center
  • SUNY Upstate Medical University
  • Wake Forest University (WFU) School of Medicine
  • Case Western Reserve University/ University Hospitals Case Medical Center
  • Tulsa Clinical Research, LLC
  • Hospital at the University of Pennsylvania, Penn Memory Center
  • University of Pittsburgh, Alzheimer Disease Research Center
  • Abington Neurological Associates, LTD.
  • Roper St. Francis Healthcare
  • Vanderbilt University Medical Center -VUIIS
  • University of North Texas Health Science Center
  • Houston Methodist Hospital
  • University of Wisconsin Hospital and Clinics
  • Cary J. Kohlenberg MD., SC dba IPC Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

T-817MA-H

T-817MA-L

Placebo

Arm Description

224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.

224 mg T-817MA once daily

Placebo once daily

Outcomes

Primary Outcome Measures

ADAS-cog Change From Baseline to Week 52
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
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

ADCS-ADL Change From Baseline to Week 52
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.

Full Information

First Posted
March 4, 2014
Last Updated
February 12, 2019
Sponsor
FUJIFILM Toyama Chemical Co., Ltd.
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
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1. Study Identification

Unique Protocol Identification Number
NCT02079909
Brief Title
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 5, 2017 (Actual)
Study Completion Date
May 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FUJIFILM Toyama Chemical Co., Ltd.
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, Alzheimer's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-817MA-H
Arm Type
Experimental
Arm Description
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
Arm Title
T-817MA-L
Arm Type
Experimental
Arm Description
224 mg T-817MA once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
T-817MA-H
Intervention Description
224 mg or 448 mg T-817 MA once daily
Intervention Type
Drug
Intervention Name(s)
T-817MA-L
Intervention Description
224 mg T-817 MA once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
ADAS-cog Change From Baseline to Week 52
Description
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).
Time Frame
Baseline and 52 weeks
Title
CGIC
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
ADCS-ADL Change From Baseline to Week 52
Description
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.
Time Frame
Baseline and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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®)
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
Country
United States
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
Country
United States
Facility Name
UCSD Comprehensive Alzheimer's Program
City
La Jolla
State/Province
California
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
Country
United States
Facility Name
Geriatric and Adult Psychiatry, LCC
City
Hamden
State/Province
Connecticut
Country
United States
Facility Name
Yale University, Alzheimer's Disease Research Unit
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
Georgetown University Clinical Research Unit
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
University of Miami Miller-School of Medicine
City
Miami
State/Province
Florida
Country
United States
Facility Name
Scientific Clinical Research, Inc
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Neuro Trials Research, Inc
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Indiana Medical Research
City
Elkhart
State/Province
Indiana
Country
United States
Facility Name
Indiana University Health Partners, Adult Neurology Clinic
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
University of Kansas/Clinical and Translational Science Unit
City
Fairway
State/Province
Kansas
Country
United States
Facility Name
University of Kentucky Sanders-Brown Center on Aging Clinic
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Acadia Hospital
City
Bangor
State/Province
Maine
Country
United States
Facility Name
Boston University Alzheimer's Disease Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Health System/ Michigan Clinical Research Unit
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
Country
United States
Facility Name
Bronson Neurobehvioral Health
City
Paw Paw
State/Province
Michigan
Country
United States
Facility Name
University of Nebraska Medical Center(Geri Psych)
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Global Medical Institutes, LLC;Princeton Medical Institute
City
Princeton
State/Province
New Jersey
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
Country
United States
Facility Name
Alzheimer's Disease Research Center of Mount Sinai
City
New York
State/Province
New York
Country
United States
Facility Name
Columbia University Medical Center Sergievsky Center Taub Institute
City
New York
State/Province
New York
Country
United States
Facility Name
The Nathan S. Kline Instituite for Psychiatric Research
City
Orangeburg
State/Province
New York
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Wake Forest University (WFU) School of Medicine
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Case Western Reserve University/ University Hospitals Case Medical Center
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Hospital at the University of Pennsylvania, Penn Memory Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh, Alzheimer Disease Research Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Abington Neurological Associates, LTD.
City
Willow Grove
State/Province
Pennsylvania
Country
United States
Facility Name
Roper St. Francis Healthcare
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Vanderbilt University Medical Center -VUIIS
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Cary J. Kohlenberg MD., SC dba IPC Research
City
Waukesha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31282954
Citation
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.
Results Reference
derived

Learn more about this trial

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

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