Alzheimer's DiseasePhase 2NCT00602680
Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease
A Phase 2 study testing SSR180711C and donepezil in people with Alzheimer's Disease, run by Sanofi at 1 site in France.
Trial summary
The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SSR180711C and donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jul 2008
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with diagnosis of mild AD
Who cannot join
- Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
- Medical condition which may interfere with the study
- History of epileptic seizures
- Lens opacity
- Lack of reliable caregiver
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease
The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.
- Conditions
- Alzheimer's Disease
- Being tested
- SSR180711C, donepezil, placebo
- Keywords
- Alzheimer, cognitive
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSR180711CDrug
duration of treatment: 4 weeks
donepezilDrug
duration of treatment: 4 weeks
placeboDrug
duration of treatment: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dose 1 Receives: Drug: SSR180711C |
| 2 | Experimental | dose 2 Receives: Drug: SSR180711C |
| 3 | Experimental | dose 3 Receives: Drug: SSR180711C |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
| 5 | Active comparator | Not described Receives: Drug: donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance
Measured: 4 weeks
Secondary outcomes (1)
Cognitive, global, functional and behaviorial assessments
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Insufficient expected benefit risk
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno DUBOIS, MD, Study chair, Scientific Advisory Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602680
- Sponsor's protocol ID
- PDY10400
- Other IDs
- SSR180711, EudraCT 2007-001639-80
- Status last verified
- Jul 2009
- First submitted
- 16 Jan 2008
- Last updated
- 20 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00602680
- Acronym / sponsor ID
- PDY10400
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, cognitive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient expected benefit risk
- Enrolment
- 1 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Jan 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 assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SSR180711Cdose 1 |
| 2 | Experimental | Drug: SSR180711Cdose 2 |
| 3 | Experimental | Drug: SSR180711Cdose 3 |
| 4 | Placebo comparator | Drug: placebo |
| 5 | Active comparator | Drug: donepezil |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with diagnosis of mild AD
Key exclusion criteria (6 listed)
- Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
- Medical condition which may interfere with the study
- History of epileptic seizures
- Lens opacity
- Lack of reliable caregiver
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 |
|---|---|---|
| SSR180711Cduration of treatment: 4 weeks | Drug | 1, 2, 3 |
| donepezilduration of treatment: 4 weeks | Drug | 5 |
| placeboduration of treatment: 4 weeks | Drug | 4 |
Primary outcome
Change in cognitive performance
Time frame: 4 weeks
1 secondary outcome
Cognitive, global, functional and behaviorial assessments
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Insufficient expected benefit risk). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2009.
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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.
Bruno DUBOIS, MD study chair
Scientific Advisory Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSR180711C and donepezil in people with Alzheimer's Disease, run by Sanofi at 1 site in France.
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 1 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: stopped early, as of the sponsor's last update on 20 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: Insufficient expected benefit risk). Results are not available in the source record.
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?
Change in cognitive performance (time frame: 4 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 20 Jul 2009.