Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

Sanofi

Status and phase: Completed; Phase 2

Conditions: Dementia Alzheimer's Type

Treatments: Drug: Donepezil; Drug: SAR110894; Drug: placebo (for SAR110894)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01266525

2010-022596-64 (EudraCT Number)

U1111-1115-7535 (Other Identifier)

DRI10734

Details and patient eligibility

About

Primary Objective:

• To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy

Secondary Objectives:

• To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
• To assess the safety/tolerability of SAR110894;
• To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
• To explore caregiver time consumption and distress changes.

Full description

The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:

• Screening period: up to 4 weeks,
• Treatment period: 24 weeks,
• Follow-up period: 10 weeks.

Enrollment: 291 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes).
• Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit.

Exclusion criteria

• Age <55 years old.
• Psychotic features, agitation, or behavioral problems within the last 3 months.
• Patients unable to comply with ophthalmologic monitoring.
• Lack of consistent and 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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291 participants in 4 patient groups, including a placebo group

SAR110894 - 0.5 mg

Experimental group

Description:

SAR110894, 0.5 mg once daily along with Donepezil.

Treatment:

Drug: Donepezil

Drug: SAR110894

SAR110894 - 2 mg

Experimental group

Description:

SAR110894, 2 mg once daily along with Donepezil.

Treatment:

Drug: Donepezil

Drug: SAR110894

SAR110894 - 5 mg

Experimental group

Description:

SAR110894, 5 mg once daily along with Donepezil.

Treatment:

Drug: Donepezil

Drug: SAR110894

Placebo

Placebo Comparator group

Description:

Placebo (for SAR110894) once daily along with Donepezil.

Treatment:

Drug: Donepezil

Drug: placebo (for SAR110894)