Alzheimer DiseasePhase 3NCT00104013
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
A Phase 3 study testing xaliproden (SR57746A) in people with Alzheimer Disease, run by Sanofi at 41 sites in 10 countries.
Trial summary
The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- xaliproden (SR57746A)
- How many people
- 1,455 participants
- Where
- 41 sitesin 10 countries
- Study dates
- Nov 2003to Nov 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria
- Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive)
- Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period
- Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
- Mother tongue is English, Spanish or French (oral and written fluency)
- Signed informed consent from potential participant or legal representative and identified caregiver
Who cannot join
- Potential participant with any other cause of dementia.
- Potential participant with serious health problems other than Alzheimer's disease
- Use of an investigational drug within two months prior to randomization or during this study
Trial locations and contacts
41 sites in 10 countries.
41 sites in 10 countries
United States32 sites
The Innovative Clinical Research Center
Alexandria, Virginia, 22304
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The Ohio State University
Columbus, Ohio, 43210
Univ. of CT Health Center
Farmington, Connecticut, 06030
Hartford Research Group
Florence, Kentucky, 41042
Neurological Center
Fort Wayne, Indiana, 46805
Radiant Research
Greer, South Carolina, 29651
University Medical Center, Dept. of Psychiatry Clinical Trials
Jackson, Mississippi, 39216
CNS Healthcare
Jacksonville, Florida, 32216
Mayo Clinic
Jacksonville, Florida, 32224
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046
Harmony Research, Inc
Johnson City, Tennessee, 37601
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Lexington Clinic
Lexington, Kentucky, 40504
Neurological Physicians of Arizona, Inc.
Mesa, Arizona, 85201
Pivotal Research Centers
Mesa, Arizona, 85210
Center For Emotional Fitness
Moorestown, New Jersey, 08057
LSUHSC Geriatric Psychiatry
New Orleans, Louisiana, 70112
Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
Norfolk, Virginia, 23507
Alzheimer's Research & Clinical Programs
North Charleston, South Carolina, 29406
Renstar Medical Research
Ocala, Florida, 34471
Optimum Health Services
Oceanside, California, 92056
Vince and Associates Clinical Research
Overland Park, Kansas, 66211
Pivotal Research Centers
Peoria, Arizona, 85381
Ubhc/Umdnj667
Piscataway, New Jersey, 08855
Memory Disorder Center
Pompano Beach, Florida, 33064
Anderson Clinical Research
Redlands, California, 92374
National Clinical Research, Inc
Richmond, Virginia, 23294
Synergy Medical
Saginaw, Michigan, 48602
Radiant Research, Inc.
St Louis, Missouri, 63141
Northwest NeuroSpecialists
Tucson, Arizona, 85741-3537
Grayline Clinical Drug Trial
Wichita Falls, Texas, 76309
Australia1 site
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).
- Conditions
- Alzheimer Disease
- Being tested
- xaliproden (SR57746A)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xaliproden (SR57746A)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Secondary outcomes (1)
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2005 (estimated)
- Study startNov 2003
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104013
- Sponsor's protocol ID
- EFC2724
- Other IDs
- SR57746A
- Status last verified
- Aug 2008
- First submitted
- 18 Feb 2005
- Last updated
- 21 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT00104013
- Acronym / sponsor ID
- EFC2724
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,455 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Feb 2005 (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 purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria
Key exclusion criteria (3 listed)
- Potential participant with any other cause of dementia.
- Potential participant with serious health problems other than Alzheimer's disease
- Use of an investigational drug within two months prior to randomization or during this study
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 |
|---|---|---|
| xaliproden (SR57746A) | Drug | – |
Primary outcome
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
1 secondary outcome
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
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 21 Aug 2008.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD study director
Sanofi
41 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing xaliproden (SR57746A) in people with Alzheimer Disease, run by Sanofi at 41 sites in 10 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 6 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 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Australia, France, Hong Kong, Italy and 5 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.. 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 21 Aug 2008.