Alzheimer's DiseasePhase 2NCT02079909
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
A Phase 2 study testing T-817MA-H and T-817MA-L in people with Alzheimer's Disease, run by FUJIFILM Toyama Chemical Co., Ltd. at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- T-817MA-H and T-817MA-L
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 50 sitesUnited States
- Study dates
- Mar 2014to 5 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®)
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Dent Neurologic Institute
Amherst, New York
University of Michigan Health System/ Michigan Clinical Research Unit
Ann Arbor, Michigan
Neuro Trials Research, Inc
Atlanta, Georgia
Acadia Hospital
Bangor, Maine
Pennington Biomedical Research Center
Baton Rouge, Louisiana
Case Western Reserve University/ University Hospitals Case Medical Center
Beachwood, Ohio
Boston University Alzheimer's Disease Center
Boston, Massachusetts
Roper St. Francis Healthcare
Charleston, South Carolina
Rush University Medical Center
Chicago, Illinois
Michigan State University
East Lansing, Michigan
Indiana Medical Research
Elkhart, Indiana
University of Kansas/Clinical and Translational Science Unit
Fairway, Kansas
University of North Texas Health Science Center
Fort Worth, Texas
Neurology Center of North Orange County
Fullerton, California
Geriatric and Adult Psychiatry, LCC
Hamden, Connecticut
Infinity Clinical Research, LLC
Hollywood, Florida
Houston Methodist Hospital
Houston, Texas
Indiana University Health Partners, Adult Neurology Clinic
Indianapolis, Indiana
University of Iowa Hospitals and Clinics
Iowa City, Iowa
UCSD Comprehensive Alzheimer's Program
La Jolla, California
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada
University of Kentucky Sanders-Brown Center on Aging Clinic
Lexington, Kentucky
University of Wisconsin Hospital and Clinics
Madison, Wisconsin
University of Miami Miller-School of Medicine
Miami, Florida
Vanderbilt University Medical Center -VUIIS
Nashville, Tennessee
Yale University, Alzheimer's Disease Research Unit
New Haven, Connecticut
Alzheimer's Disease Research Center of Mount Sinai
New York, New York
Columbia University Medical Center Sergievsky Center Taub Institute
New York, New York
Scientific Clinical Research, Inc
North Miami, Florida
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut
Renstar Medical Research
Ocala, Florida
University of Nebraska Medical Center(Geri Psych)
Omaha, Nebraska
UC Irvine Medical Center
Orange, California
The Nathan S. Kline Instituite for Psychiatric Research
Orangeburg, New York
Bronson Neurobehvioral Health
Paw Paw, Michigan
Hospital at the University of Pennsylvania, Penn Memory Center
Philadelphia, Pennsylvania
Banner Alzheimer's Institute
Phoenix, Arizona
University of Pittsburgh, Alzheimer Disease Research Center
Pittsburgh, Pennsylvania
Global Medical Institutes, LLC;Princeton Medical Institute
Princeton, New Jersey
University of Rochester Medical Center
Rochester, New York
SIU School of Medicine
Springfield, Illinois
Banner Sun Health Research Institute
Sun City, Arizona
SUNY Upstate Medical University
Syracuse, New York
Meridien Research
Tampa, Florida
University of Arizona Health Sciences Center
Tucson, Arizona
Tulsa Clinical Research, LLC
Tulsa, Oklahoma
Georgetown University Clinical Research Unit
Washington D.C., District of Columbia
Cary J. Kohlenberg MD., SC dba IPC Research
Waukesha, Wisconsin
Abington Neurological Associates, LTD.
Willow Grove, Pennsylvania
Wake Forest University (WFU) School of Medicine
Winston-Salem, North Carolina
About this study
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
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).
- Conditions
- Alzheimer's Disease
- Being tested
- T-817MA-H, T-817MA-L, Placebo
- Keywords
- Alzheimer's Disease, Alzheimer's
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-817MA-HDrug
224 mg or 448 mg T-817 MA once daily
T-817MA-LDrug
224 mg T-817 MA once daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| T-817MA-H | Experimental | 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. Receives: Drug: T-817MA-H |
| T-817MA-L | Experimental | 224 mg T-817MA once daily Receives: Drug: T-817MA-L |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 52 weeks
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.
Measured: 52 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079909
- Sponsor's protocol ID
- T817MAUS202
- Status last verified
- Feb 2019
- First submitted
- 4 Mar 2014
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 31282954
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02079909
- Acronym / sponsor ID
- T817MAUS202
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Alzheimer's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Study start
- Mar 2014
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 9 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T-817MA-H | Experimental | Drug: T-817MA-H224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. |
| T-817MA-L | Experimental | Drug: T-817MA-L224 mg T-817MA once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-817MA-H224 mg or 448 mg T-817 MA once daily | Drug | T-817MA-H |
| T-817MA-L224 mg T-817 MA once daily | Drug | T-817MA-L |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
ADCS-ADL Change From Baseline to Week 52
Time frame: Baseline and 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31282954Schneider 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T-817MA-H and T-817MA-L in people with Alzheimer's Disease, run by FUJIFILM Toyama Chemical Co., Ltd. at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog Change From Baseline to Week 52 (time frame: Baseline and 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.