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Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00602680
Enrollment
1
Registered
2008-01-28
Start date
2008-01-31
Completion date
2008-07-31
Last updated
2009-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer, cognitive

Brief 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.

Interventions

DRUGSSR180711C

duration of treatment: 4 weeks

DRUGdonepezil

duration of treatment: 4 weeks

DRUGplacebo

duration of treatment: 4 weeks

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Outpatients with diagnosis of mild AD

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Change in cognitive performance4 weeks

Secondary

MeasureTime frame
Cognitive, global, functional and behaviorial assessments4 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026