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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2013

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

  • Drug: SAR110894
    • Pharmaceutical form: Capsule Route of administration: Oral
  • Drug: placebo (for SAR110894)
    • Pharmaceutical form: Capsule Route of administration: Oral
  • Drug: Donepezil
    • 5 mg or 10 mg once daily continued as taken before inclusion

Arms, Groups and Cohorts

  • Experimental: SAR110894 – 0.5 mg
    • SAR110894, 0.5 mg once daily along with Donepezil.
  • Experimental: SAR110894 – 2 mg
    • SAR110894, 2 mg once daily along with Donepezil.
  • Experimental: SAR110894 – 5 mg
    • SAR110894, 5 mg once daily along with Donepezil.
  • Placebo Comparator: Placebo
    • Placebo (for SAR110894) once daily along with Donepezil.

Clinical Trial Outcome Measures

Primary Measures

  • 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).
    • Time Frame: Week 4, 12, and 24

Secondary Measures

  • Change from baseline in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) global score
    • Time Frame: 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”)
    • Time Frame: Week 4, 12, and 24
  • Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
    • Time Frame: Week 4, 12, and 24
  • Change from baseline in the Mini Mental State Examination (MMSE) total score
    • Time Frame: Week 4, 12, and 24

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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