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

Phase 2

Completed

Interventions: Drug: SAR110894
Drug: placebo (for SAR110894)
Drug: Donepezil

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
SAR110894 - 0.5 mg	SAR110894	SAR110894, 0.5 mg once daily along with Donepezil.
SAR110894 - 2 mg	SAR110894	SAR110894, 2 mg once daily along with Donepezil.
Placebo	placebo (for SAR110894)	Placebo (for SAR110894) once daily along with Donepezil.
SAR110894 - 5 mg	SAR110894	SAR110894, 5 mg once daily along with Donepezil.
SAR110894 - 0.5 mg	Donepezil	SAR110894, 0.5 mg once daily along with Donepezil.
SAR110894 - 2 mg	Donepezil	SAR110894, 2 mg once daily along with Donepezil.
SAR110894 - 5 mg	Donepezil	SAR110894, 5 mg once daily along with Donepezil.
Placebo	Donepezil	Placebo (for SAR110894) once daily along with Donepezil.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (82): Investigational Site Number 840041
🇺🇸
Gilbert, Arizona, United States
Investigational Site Number 840032
🇺🇸
Phoenix, Arizona, United States
Investigational Site Number 840024
🇺🇸
Costa Mesa, California, United States
Investigational Site Number 840013
🇺🇸
Fresno, California, United States
Investigational Site Number 840030
🇺🇸
La Jolla, California, United States
Investigational Site Number 840001
🇺🇸
Redlands, California, United States
Investigational Site Number 840002
🇺🇸
Santa Ana, California, United States
Investigational Site Number 840026
🇺🇸
Sherman Oaks, California, United States
Investigational Site Number 840034
🇺🇸
Darien, Connecticut, United States
Investigational Site Number 840003
🇺🇸
Delray Beach, Florida, United States
Scroll for more (72 remaining)
Investigational Site Number 840041
🇺🇸Gilbert, Arizona, United States