Alzheimer DiseasePhase 2NCT00285077
Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
A Phase 2 study testing SR57667B in people with Alzheimer Disease, run by Sanofi at 7 sites in 7 countries.
Trial summary
The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD). A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B. 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
- 390 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Mar 2004to Nov 2006
- 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
- Patients who have participated in Study EFC5286 and completed the study.
- 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 specifically for this LTS5283 extension.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).
A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.
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.
Adverse events recorded quarterly.
Secondary outcomes (1)
ADAS-cog, CDR, 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 2004
- Primary completionNov 2006
- Study completionNov 2006
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
- Who is masked
- Participant, Investigator
- Enrolment
- 390 participants (actual)
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
- NCT00285077
- Sponsor's protocol ID
- LTS5283
- Status last verified
- Dec 2008
- First submitted
- 31 Jan 2006
- Last updated
- 23 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00285077
- Acronym / sponsor ID
- LTS5283
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, nerve growth factors, Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- 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 assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).
A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.
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 (participant, investigator)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have participated in Study EFC5286 and completed the study.
- 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 specifically for this LTS5283 extension.
Key exclusion criteria (2 listed)
- 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.
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
Adverse events recorded quarterly.
1 secondary outcome
ADAS-cog, CDR, 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 23 Dec 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.
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
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR57667B in people with Alzheimer Disease, run by Sanofi at 7 sites in 7 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 2 inclusion and 2 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 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Denmark, Finland, France, Germany and 2 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 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?
Adverse events recorded quarterly.. 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 23 Dec 2008.