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

NCT01266525 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2016-03-14

No results posted yet for this study

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.

Conditions

  • Dementia Alzheimer's Type

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266525 on ClinicalTrials.gov