Alzheimer DiseasePhase 2NCT00285025
Study of the Effect of SR57667B in Patients With Alzheimer's Disease
A Phase 2 study testing SR57667B in people with Alzheimer Disease, run by Sanofi.
Trial summary
The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD. 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?
- SR57667B
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Sep 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male / female outpatients.
- Age > 50 years at screening.
- Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score > 12 and < 26.
- Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
- Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
- Presence of a reliable caregiver.
- Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures
Who cannot join
- Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
- Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
- Females who are pregnant or breast-feeding. Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit, and must use an acceptable method of birth control.
- Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
- Use of CYP3A4 strong inhibitors
- Evidence (detected by history, physical examination and / or laboratory / ECG tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
About this study
Official title: A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD.
Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.
Read the detailed description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
- Conditions
- Alzheimer Disease
- Being tested
- SR57667B
- Keywords
- Alzheimer disease, nerve growth factors, Clinical Trial
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR57667BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
Secondary outcomes (1)
MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startMar 2005
- Study completionSep 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Serge GAUTHIER, MD, Study chair, Scientific Advisory CommitteeJean-Marc ORGOGOZO, MD, Study chair, Scientific Advisory CommitteePhilip SCHELTENS, MD, Study chair, Scientific Advisory CommitteeBengt WINBLAD, MD, Study chair, Scientific Advisory Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285025
- Sponsor's protocol ID
- EFC5286
- Other IDs
- SR57667B
- Status last verified
- Jan 2006
- First submitted
- 31 Jan 2006
- Last updated
- 1 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00285025
- Acronym / sponsor ID
- EFC5286
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, nerve growth factors, Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Sep 2005
- First posted
- 1 Feb 2006 (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 is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD.
Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.
Detailed description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
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 (7 listed)
- Male / female outpatients.
- Age > 50 years at screening.
- Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score > 12 and < 26.
- Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
- Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
Key exclusion criteria (6 listed)
- Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
- Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
- Females who are pregnant or breast-feeding. Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit, and must use an acceptable method of birth control.
- Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
- Use of CYP3A4 strong inhibitors
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 |
|---|---|---|
| SR57667B | Drug | – |
Primary outcome
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
1 secondary outcome
MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.
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 1 Feb 2006.
- 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.
Serge GAUTHIER, MD study chair
Scientific Advisory Committee
Jean-Marc ORGOGOZO, MD study chair
Scientific Advisory Committee
Philip SCHELTENS, MD study chair
Scientific Advisory Committee
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR57667B in people with Alzheimer Disease, run by Sanofi.
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 6 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 1 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
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 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?
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.. 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 1 Feb 2006.