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

February 12, 2016 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Investigational Site Number 036002
      • Chermside, Australia, 4032
        • Investigational Site Number 036007
      • Heidelberg West, Australia, 3081
        • Investigational Site Number 036008
      • Herston, Australia, 4029
        • Investigational Site Number 036006
      • Nedlands, Australia, 6009
        • Investigational Site Number 036001
      • Randwick, Australia, 2031
        • Investigational Site Number 036004
      • Toowoomba, Australia, 4350
        • Investigational Site Number 036009
      • Waratah, Australia, 2298
        • Investigational Site Number 036005
      • Woodville, Australia, 5011
        • Investigational Site Number 036003
  • Canada
      • Calgary, Canada, T2N 2T9
        • Investigational Site Number 124010
      • Gatineau, Canada, J9A 1K7
        • Investigational Site Number 124015
      • Greenfield Park, Canada, J4V 4J2
        • Investigational Site Number 124009
      • Halifax, Canada, B3H 2E1
        • Investigational Site Number 124014
      • London, Canada, N6C 5J1
        • Investigational Site Number 124001
      • Montreal, Canada, H4H 1R3
        • Investigational Site Number 124011
      • Ottawa, Canada, K1G 4G3
        • Investigational Site Number 124008
      • Regina, Canada, S4T 1A5
        • Investigational Site Number 124013
      • Sherbrooke, Canada, J1H 4C4
        • Investigational Site Number 124003
      • St. John, Canada, E2L 3L6
        • Investigational Site Number 124006
      • Toronto, Canada, M3B 2S7
        • Investigational Site Number 124002
      • Toronto, Canada, M4N 3M5
        • Investigational Site Number 124004
  • France
      • Bordeaux, France, 33076
        • Investigational Site Number 250004
      • Lille Cedex, France, 59037
        • Investigational Site Number 250001
      • Limoges, France, 87042
        • Investigational Site Number 250009
      • Marseille, France, 13385
        • Investigational Site Number 250007
      • Nantes, France, 44035
        • Investigational Site Number 250003
      • Nice, France, 06000
        • Investigational Site Number 250005
      • Paris, France, 75013
        • Investigational Site Number 250006
      • Strasbourg Cedex, France, 67091
        • Investigational Site Number 250008
      • Toulouse Cedex 3, France, 31059
        • Investigational Site Number 250002
  • Germany
      • Berlin, Germany, 10629
        • Investigational Site Number 276011
      • Dresden, Germany, 01307
        • Investigational Site Number 276012
      • München, Germany, 80331
        • Investigational Site Number 276007
      • München, Germany, 80331
        • Investigational Site Number 276008
      • Schwerin, Germany, 19053
        • Investigational Site Number 276001
      • Würzburg, Germany, 97070
        • Investigational Site Number 276009
  • Italy
      • Ancona, Italy, 60020
        • Investigational Site Number 380006
      • Castellanza, Italy, 21053
        • Investigational Site Number 380004
      • Cefalù, Italy, 90015
        • Investigational Site Number 380005
      • Milano, Italy, 20132
        • Investigational Site Number 380001
      • Milano, Italy, 20122
        • Investigational Site Number 380002
      • Milano, Italy, 20162
        • Investigational Site Number 380003
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Investigational Site Number 616004
      • Gdansk, Poland, 80-266
        • Investigational Site Number 616003
      • Gdynia, Poland, 81-361
        • Investigational Site Number 616001
      • Poznan, Poland, 61-289
        • Investigational Site Number 616002
      • Szczecin, Poland, 70-215
        • Investigational Site Number 616006
      • Warszawa, Poland, 02-507
        • Investigational Site Number 616005
  • Portugal
      • Amadora, Portugal, 2720-276
        • Investigational Site Number 620002
      • Lisboa, Portugal, 1649-035
        • Investigational Site Number 620001
  • Spain
      • Algorta, Spain, 48993
        • Investigational Site Number 724002
      • Barcelona, Spain, 08907
        • Investigational Site Number 724001
      • Madrid, Spain, 28029
        • Investigational Site Number 724008
      • Sevilla, Spain, 41007
        • Investigational Site Number 724007
      • Terrassa, Spain, 08221
        • Investigational Site Number 724003
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Investigational Site Number 840041
      • Phoenix, Arizona, United States, 85060
        • Investigational Site Number 840032
    • California
      • Costa Mesa, California, United States, 92626
        • Investigational Site Number 840024
      • Fresno, California, United States, 93720
        • Investigational Site Number 840013
      • La Jolla, California, United States, 92037
        • Investigational Site Number 840030
      • Redlands, California, United States, 92374
        • Investigational Site Number 840001
      • Santa Ana, California, United States, 92705
        • Investigational Site Number 840002
      • Sherman Oaks, California, United States, 91403
        • Investigational Site Number 840026
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Investigational Site Number 840034
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Investigational Site Number 840003
      • Hialeah, Florida, United States, 33016
        • Investigational Site Number 840015
      • Jacksonville, Florida, United States, 32216
        • Investigational Site Number 840004
      • Miami, Florida, United States, 33155
        • Investigational Site Number 840006
      • Orlando, Florida, United States, 32806
        • Investigational Site Number 840012
      • Tampa, Florida, United States, 33609-4052
        • Investigational Site Number 840011
      • W Palm Beach, Florida, United States, 33407
        • Investigational Site Number 840005
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Investigational Site Number 840008
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Investigational Site Number 840025
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Investigational Site Number 840009
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Investigational Site Number 840040
    • New York
      • Cedarhurst, New York, United States, 11516
        • Investigational Site Number 840018
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Investigational Site Number 840039
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Investigational Site Number 840037
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Investigational Site Number 840014
    • Texas
      • Austin, Texas, United States, 78757
        • Investigational Site Number 840038
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Investigational Site Number 840021
    • Virginia
      • Williamsburg, Virginia, United States, 23185
        • Investigational Site Number 840031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SAR110894 - 0.5 mg
SAR110894, 0.5 mg once daily along with Donepezil.
Drug: SAR110894

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
EXPERIMENTAL: SAR110894 - 2 mg
SAR110894, 2 mg once daily along with Donepezil.
Drug: SAR110894

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
EXPERIMENTAL: SAR110894 - 5 mg
SAR110894, 5 mg once daily along with Donepezil.
Drug: SAR110894

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
PLACEBO_COMPARATOR: Placebo
Placebo (for SAR110894) once daily along with Donepezil.
Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Drug: placebo (for SAR110894)

Pharmaceutical form: Capsule

Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 4, 12, and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Week 4, 12, and 24
Change from baseline in the Mini Mental State Examination (MMSE) total score
Time Frame: Week 4, 12, and 24
Week 4, 12, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (ESTIMATE)

December 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI10734
  • 2010-022596-64 (EUDRACT_NUMBER)
  • U1111-1115-7535 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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