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

Phase 2TerminatedNCT00602680

Sanofi1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

SSR180711CDRUG

duration of treatment: 4 weeks

donepezilDRUG

duration of treatment: 4 weeks

placeboDRUG

duration of treatment: 4 weeks

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Change in cognitive performance

Time frame: 4 weeks

Secondary Outcomes

Cognitive, global, functional and behaviorial assessments

Time frame: 4 weeks

Data from ClinicalTrials.gov

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