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

Tracking Information
First Submitted Date ICMJE	December 23, 2010
First Posted Date ICMJE	December 24, 2010
Last Update Posted Date	March 14, 2016
Study Start Date ICMJE	February 2011
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 23, 2010)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01266525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 23, 2010)	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 ]; 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 ]; 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 ]; Change from baseline in the Mini Mental State Examination (MMSE) total score [ Time Frame: Week 4, 12, and 24 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Dementia Alzheimer's Type
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 8, 2013)	291
Original Estimated Enrollment ICMJE; (submitted: December 23, 2010)	520
Actual Study Completion Date	January 2013
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	55 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Canada, France, Germany, Italy, Poland, Portugal, Spain, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01266525
Other Study ID Numbers ICMJE	DRI10734; 2010-022596-64 ( EudraCT Number ); U1111-1115-7535 ( Other Identifier: UTN )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Sanofi
Study Sponsor ICMJE	Sanofi
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Clinical Sciences & Operations Sanofi
PRS Account	Sanofi
Verification Date	February 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP