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

February 12, 2019 updated by: FUJIFILM Toyama Chemical Co., Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
482

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Banner Alzheimer's Institute
      • Sun City, Arizona, United States
        • Banner Sun Health Research Institute
      • Tucson, Arizona, United States
        • University of Arizona Health Sciences Center
    • California
      • Fullerton, California, United States
        • Neurology Center of North Orange County
      • La Jolla, California, United States
        • UCSD Comprehensive Alzheimer's Program
      • Orange, California, United States
        • UC Irvine Medical Center
    • Connecticut
      • Hamden, Connecticut, United States
        • Geriatric and Adult Psychiatry, LCC
      • New Haven, Connecticut, United States
        • Yale University, Alzheimer's Disease Research Unit
      • Norwalk, Connecticut, United States
        • Research Center for Clinical Studies, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University Clinical Research Unit
    • Florida
      • Hollywood, Florida, United States
        • Infinity Clinical Research, LLC
      • Miami, Florida, United States
        • University of Miami Miller-School of Medicine
      • North Miami, Florida, United States
        • Scientific Clinical Research, Inc
      • Ocala, Florida, United States
        • Renstar Medical Research
      • Tampa, Florida, United States
        • Meridien Research
    • Georgia
      • Atlanta, Georgia, United States
        • Neuro Trials Research, Inc
    • Illinois
      • Chicago, Illinois, United States
        • Rush University Medical Center
      • Springfield, Illinois, United States
        • SIU School of Medicine
    • Indiana
      • Elkhart, Indiana, United States
        • Indiana Medical Research
      • Indianapolis, Indiana, United States
        • Indiana University Health Partners, Adult Neurology Clinic
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Fairway, Kansas, United States
        • University of Kansas/Clinical and Translational Science Unit
    • Kentucky
      • Lexington, Kentucky, United States
        • University of Kentucky Sanders-Brown Center on Aging Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Pennington Biomedical Research Center
    • Maine
      • Bangor, Maine, United States
        • Acadia Hospital
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston University Alzheimer's Disease Center
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Health System/ Michigan Clinical Research Unit
      • East Lansing, Michigan, United States
        • Michigan State University
      • Paw Paw, Michigan, United States
        • Bronson Neurobehvioral Health
    • Nebraska
      • Omaha, Nebraska, United States
        • University of Nebraska Medical Center(Geri Psych)
    • Nevada
      • Las Vegas, Nevada, United States
        • Cleveland Clinic Lou Ruvo Center for Brain Health
    • New Jersey
      • Princeton, New Jersey, United States
        • Global Medical Institutes, LLC;Princeton Medical Institute
    • New York
      • Amherst, New York, United States
        • Dent Neurologic Institute
      • New York, New York, United States
        • Alzheimer's Disease Research Center of Mount Sinai
      • New York, New York, United States
        • Columbia University Medical Center Sergievsky Center Taub Institute
      • Orangeburg, New York, United States
        • The Nathan S. Kline Instituite for Psychiatric Research
      • Rochester, New York, United States
        • University of Rochester Medical Center
      • Syracuse, New York, United States
        • SUNY Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Wake Forest University (WFU) School of Medicine
    • Ohio
      • Beachwood, Ohio, United States
        • Case Western Reserve University/ University Hospitals Case Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Tulsa Clinical Research, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Hospital at the University of Pennsylvania, Penn Memory Center
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh, Alzheimer Disease Research Center
      • Willow Grove, Pennsylvania, United States
        • Abington Neurological Associates, Ltd.
    • South Carolina
      • Charleston, South Carolina, United States
        • Roper St. Francis Healthcare
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center -VUIIS
    • Texas
      • Fort Worth, Texas, United States
        • University of North Texas Health Science Center
      • Houston, Texas, United States
        • Houston Methodist Hospital
    • Wisconsin
      • Madison, Wisconsin, United States
        • University of Wisconsin Hospital and Clinics
      • Waukesha, Wisconsin, United States
        • Cary J. Kohlenberg MD., SC dba IPC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 52 weeks
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.
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FUJIFILM Toyama Chemical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alzheimer's Disease Cooperative Study (ADCS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T817MAUS202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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