Alzheimer's DiseasePhase 2NCT00663936
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing T-817MA in people with Alzheimer's Disease, run by FUJIFILM Toyama Chemical Co., Ltd. at 35 sites in 2 countries.
Trial summary
The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- T-817MA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Apr 2008to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 to 90 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.
- Age 50 to 90 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 etc (According to the protocol)
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 for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States33 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
NeuroPsychiatric Center of the Palm Beaches
Boynton Beach, Florida, 33426
Brooklyn Medical Institute
Brooklyn, New York, 11214
SPRI Clinical Trials
Brooklyn, New York, 11235
The Alzheimer's Memory Center
Charlotte, North Carolina, 28211
Columbus Research & Wellness Institute
Columbus, Georgia, 31907
Radiant Research
Denver, Colorado, 80239
Duke University Medical Center
Durham, North Carolina, 27705
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Geriatric and Adult Psychiatry, LCC
Hamden, Connecticut, 06518
Agewell
Indianapolis, Indiana, 46260
The Clinical Trials Center
Jenkintown, Pennsylvania, 19046
Cleveland Clinic - Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
Galiz Research
Miami Springs, Florida, 33166
Anchor Research Center
Naples, Florida, 34102
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851
Renstar Medical Research
Ocala, Florida, 34471
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Southwest Institute for Clinical Research, Inc.
Rancho Mirage, California, 92270
Alzheimer's Disease Center, U. of Rochester Medical Center
Rochester, New York, 14620
Innovative Clinical Trials
San Antonio, Texas, 78229
Pacific Research Network, Inc.
San Diego, California, 92103
San Francisco Clinical Research Center
San Francisco, California, 94109
Richmond Behavioral Associates
Staten Island, New York, 10312
Axiom Clinical Research of Florida
Tampa, Florida, 33609
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
Tampa, Florida, 33613
Memory Enhancement Center of America
Toms River, New Jersey, 08755
Northwest NeuroSpecialists
Tucson, Arizona, 85741
IPC Research
Waukesha, Wisconsin, 53188
Premiere Research Institute
West Palm Beach, Florida, 33407
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, 27103
Canada2 sites
St. Joseph's Hospital
Saint John, New Brunswick, E2L 3L6
Toronto Memory Program
Toronto, Ontario, M3B 2S7
About this study
Official title: A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease
The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
- Conditions
- Alzheimer's Disease
- Being tested
- T-817MA, 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-817MADrug
224 mg T-817 MA once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | T-817MA once daily Receives: Drug: T-817MA |
| 2 | 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.
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
Measured: 52 weeks
Secondary outcomes (1)
Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663936
- Sponsor's protocol ID
- AA4437420
- Status last verified
- Dec 2012
- First submitted
- 18 Apr 2008
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00663936
- Acronym / sponsor ID
- AA4437420
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Alzheimer's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: T-817MAT-817MA once daily |
| 2 | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 50 to 90 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.
- Age 50 to 90 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 for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).
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-817MA224 mg T-817 MA once daily | Drug | 1 |
| PlaceboPlacebo once daily | Drug | 2 |
Primary outcome
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
Time frame: 52 weeks
1 secondary outcome
Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
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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.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T-817MA in people with Alzheimer's Disease, run by FUJIFILM Toyama Chemical Co., Ltd. at 35 sites in 2 countries.
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 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2013.