Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
- Conditions
- Dementia Alzheimer's Type
- Interventions
- Registration Number
- NCT01266525
- Lead Sponsor
- Sanofi
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR110894 - 0.5 mg SAR110894 SAR110894, 0.5 mg once daily along with Donepezil. SAR110894 - 2 mg SAR110894 SAR110894, 2 mg once daily along with Donepezil. Placebo placebo (for SAR110894) Placebo (for SAR110894) once daily along with Donepezil. SAR110894 - 5 mg SAR110894 SAR110894, 5 mg once daily along with Donepezil. SAR110894 - 0.5 mg Donepezil SAR110894, 0.5 mg once daily along with Donepezil. SAR110894 - 2 mg Donepezil SAR110894, 2 mg once daily along with Donepezil. SAR110894 - 5 mg Donepezil SAR110894, 5 mg once daily along with Donepezil. Placebo Donepezil Placebo (for SAR110894) once daily along with Donepezil.
- Primary Outcome Measures
Name Time Method 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). Week 4, 12, and 24
- Secondary Outcome Measures
Name Time Method Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score 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") Week 4, 12, and 24 Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment Week 4, 12, and 24 Change from baseline in the Mini Mental State Examination (MMSE) total score Week 4, 12, and 24
Trial Locations
- Locations (82)
Investigational Site Number 840024
🇺🇸Costa Mesa, California, United States
Investigational Site Number 840041
🇺🇸Gilbert, Arizona, United States
Investigational Site Number 616004
🇵🇱Bydgoszcz, Poland
Investigational Site Number 840034
🇺🇸Darien, Connecticut, United States
Investigational Site Number 840009
🇺🇸Hattiesburg, Mississippi, United States
Investigational Site Number 616001
🇵🇱Gdynia, Poland
Investigational Site Number 616005
🇵🇱Warszawa, Poland
Investigational Site Number 840014
🇺🇸Franklin, Tennessee, United States
Investigational Site Number 840021
🇺🇸Bennington, Vermont, United States
Investigational Site Number 616006
🇵🇱Szczecin, Poland
Investigational Site Number 620002
🇵🇹Amadora, Portugal
Investigational Site Number 620001
🇵🇹Lisboa, Portugal
Investigational Site Number 840001
🇺🇸Redlands, California, United States
Investigational Site Number 840005
🇺🇸W Palm Beach, Florida, United States
Investigational Site Number 840026
🇺🇸Sherman Oaks, California, United States
Investigational Site Number 840002
🇺🇸Santa Ana, California, United States
Investigational Site Number 840030
🇺🇸La Jolla, California, United States
Investigational Site Number 840015
🇺🇸Hialeah, Florida, United States
Investigational Site Number 036005
🇦🇺Waratah, Australia
Investigational Site Number 036001
🇦🇺Nedlands, Australia
Investigational Site Number 840003
🇺🇸Delray Beach, Florida, United States
Investigational Site Number 840025
🇺🇸Quincy, Massachusetts, United States
Investigational Site Number 840031
🇺🇸Williamsburg, Virginia, United States
Investigational Site Number 036008
🇦🇺Heidelberg West, Australia
Investigational Site Number 380002
🇮🇹Milano, Italy
Investigational Site Number 380001
🇮🇹Milano, Italy
Investigational Site Number 840004
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840039
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 250006
🇫🇷Paris, France
Investigational Site Number 036003
🇦🇺Woodville, Australia
Investigational Site Number 036006
🇦🇺Herston, Australia
Investigational Site Number 276009
🇩🇪Würzburg, Germany
Investigational Site Number 380006
🇮🇹Ancona, Italy
Investigational Site Number 250009
🇫🇷Limoges, France
Investigational Site Number 124004
🇨🇦Toronto, Canada
Investigational Site Number 840040
🇺🇸Eatontown, New Jersey, United States
Investigational Site Number 840018
🇺🇸Cedarhurst, New York, United States
Investigational Site Number 036009
🇦🇺Toowoomba, Australia
Investigational Site Number 124008
🇨🇦Ottawa, Canada
Investigational Site Number 036007
🇦🇺Chermside, Australia
Investigational Site Number 124014
🇨🇦Halifax, Canada
Investigational Site Number 616003
🇵🇱Gdansk, Poland
Investigational Site Number 380003
🇮🇹Milano, Italy
Investigational Site Number 250004
🇫🇷Bordeaux, France
Investigational Site Number 250007
🇫🇷Marseille, France
Investigational Site Number 250008
🇫🇷Strasbourg Cedex, France
Investigational Site Number 124013
🇨🇦Regina, Canada
Investigational Site Number 124001
🇨🇦London, Canada
Investigational Site Number 124002
🇨🇦Toronto, Canada
Investigational Site Number 036004
🇦🇺Randwick, Australia
Investigational Site Number 276008
🇩🇪München, Germany
Investigational Site Number 124010
🇨🇦Calgary, Canada
Investigational Site Number 380005
🇮🇹Cefalù, Italy
Investigational Site Number 250005
🇫🇷Nice, France
Investigational Site Number 724008
🇪🇸Madrid, Spain
Investigational Site Number 124003
🇨🇦Sherbrooke, Canada
Investigational Site Number 276012
🇩🇪Dresden, Germany
Investigational Site Number 124006
🇨🇦St. John, Canada
Investigational Site Number 276001
🇩🇪Schwerin, Germany
Investigational Site Number 616002
🇵🇱Poznan, Poland
Investigational Site Number 380004
🇮🇹Castellanza, Italy
Investigational Site Number 250003
🇫🇷Nantes, France
Investigational Site Number 250001
🇫🇷Lille Cedex, France
Investigational Site Number 124015
🇨🇦Gatineau, Canada
Investigational Site Number 724002
🇪🇸Algorta, Spain
Investigational Site Number 724001
🇪🇸Barcelona, Spain
Investigational Site Number 840032
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840006
🇺🇸Miami, Florida, United States
Investigational Site Number 840013
🇺🇸Fresno, California, United States
Investigational Site Number 840008
🇺🇸Baton Rouge, Louisiana, United States
Investigational Site Number 840037
🇺🇸Tulsa, Oklahoma, United States
Investigational Site Number 036002
🇦🇺Adelaide, Australia
Investigational Site Number 124009
🇨🇦Greenfield Park, Canada
Investigational Site Number 124011
🇨🇦Montreal, Canada
Investigational Site Number 276011
🇩🇪Berlin, Germany
Investigational Site Number 276007
🇩🇪München, Germany
Investigational Site Number 250002
🇫🇷Toulouse Cedex 3, France
Investigational Site Number 724003
🇪🇸Terrassa, Spain
Investigational Site Number 724007
🇪🇸Sevilla, Spain
Investigational Site Number 840011
🇺🇸Tampa, Florida, United States
Investigational Site Number 840038
🇺🇸Austin, Texas, United States
Investigational Site Number 840012
🇺🇸Orlando, Florida, United States