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OpenTrials
Completed

NCT Number: NCT01266525

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

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.

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Key information

Conditions

Dementia Alzheimer's Type Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 036002, Adelaide, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR110894

Drug

Pharmaceutical form: Capsule

Route of administration: Oral

placebo (for SAR110894)

Drug

Pharmaceutical form: Capsule

Route of administration: Oral

Donepezil

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Change from baseline in the Mini Mental State Examination (MMSE) total score

    Time frame: Week 4, 12, and 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2010
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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