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

Tracking Information

First Received Date ^ICMJE

December 23, 2010

Last Updated Date

February 12, 2016

Start Date ^ICMJE

February 2011

Primary Completion Date

January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

291

Completion Date

January 2013

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

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

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