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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: placebo; Drug: SSR180711C; Drug: donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00602680

PDY10400

EudraCT 2007-001639-80

SSR180711

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

dose 1

Treatment:

Drug: SSR180711C

2

Experimental group

Description:

dose 2

Treatment:

Drug: SSR180711C

3

Experimental group

Description:

dose 3

Treatment:

Drug: SSR180711C

4

Placebo Comparator group

Treatment:

Drug: placebo

5

Active Comparator group

Treatment:

Drug: donepezil