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

A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01266525

Enrollment

291

Registered

2010-12-24

Start date

2011-02-28

Completion date

2013-01-31

Last updated

2016-03-14

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

Conditions

Dementia Alzheimer's Type

Brief summary

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.

Detailed 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.

Interventions

DRUGSAR110894

Pharmaceutical form: Capsule Route of administration: Oral

DRUGplacebo (for SAR110894)

Pharmaceutical form: Capsule Route of administration: Oral

DRUGDonepezil

5 mg or 10 mg once daily continued as taken before inclusion

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 No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).	Week 4, 12, and 24

Secondary

Measure	Time frame
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score	Week 4, 12, and 24
Change from baseline in each of the two remaining items of the ADAS-Cog (namely delayed word recall and concentration/distractibility)	Week 4, 12, and 24
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment	Week 4, 12, and 24
Change from baseline in the Mini Mental State Examination (MMSE) total score	Week 4, 12, and 24

Countries

Australia, Canada, France, Germany, Italy, Poland, Portugal, Spain, United States

Outcome results

None listed

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