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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01266525
First received: December 23, 2010
Last updated: February 12, 2016
Last verified: February 2016
History of Changes

December 23, 2010
February 12, 2016
February 2011
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01266525 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in the Mini Mental State Examination (MMSE) total score [ Time Frame: Week 4, 12, and 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dementia Alzheimer's Type
  • 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
  • Experimental: SAR110894 - 0.5 mg
    SAR110894, 0.5 mg once daily along with Donepezil.
    Interventions:
    • Drug: SAR110894
    • Drug: Donepezil
  • Experimental: SAR110894 - 2 mg
    SAR110894, 2 mg once daily along with Donepezil.
    Interventions:
    • Drug: SAR110894
    • Drug: Donepezil
  • Experimental: SAR110894 - 5 mg
    SAR110894, 5 mg once daily along with Donepezil.
    Interventions:
    • Drug: SAR110894
    • Drug: Donepezil
  • Placebo Comparator: Placebo
    Placebo (for SAR110894) once daily along with Donepezil.
    Interventions:
    • Drug: placebo (for SAR110894)
    • Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
291
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Italy,   Poland,   Portugal,   Spain
 
NCT01266525
DRI10734, 2010-022596-64, U1111-1115-7535
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP