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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01266525




Registration number
NCT01266525
Ethics application status
Date submitted
23/12/2010
Date registered
24/12/2010
Date last updated
14/03/2016

Titles & IDs
Public title
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Scientific title
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
Secondary ID [1] 0 0
2010-022596-64
Secondary ID [2] 0 0
DRI10734
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia Alzheimer's Type 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAR110894
Treatment: Drugs - placebo (for SAR110894)
Treatment: Drugs - Donepezil

Experimental: SAR110894 - 0.5 mg - SAR110894, 0.5 mg once daily along with Donepezil.

Experimental: SAR110894 - 2 mg - SAR110894, 2 mg once daily along with Donepezil.

Experimental: SAR110894 - 5 mg - SAR110894, 5 mg once daily along with Donepezil.

Placebo comparator: Placebo - Placebo (for SAR110894) once daily along with Donepezil.


Treatment: Drugs: SAR110894
Pharmaceutical form: Capsule

Route of administration: Oral

Treatment: Drugs: placebo (for SAR110894)
Pharmaceutical form: Capsule

Route of administration: Oral

Treatment: Drugs: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Week 4, 12, and 24
Secondary outcome [1] 0 0
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
Timepoint [1] 0 0
Week 4, 12, and 24
Secondary outcome [2] 0 0
Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
Timepoint [2] 0 0
Week 4, 12, and 24
Secondary outcome [3] 0 0
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
Timepoint [3] 0 0
Week 4, 12, and 24
Secondary outcome [4] 0 0
Change from baseline in the Mini Mental State Examination (MMSE) total score
Timepoint [4] 0 0
Week 4, 12, and 24

Eligibility
Key inclusion criteria
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.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
291
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036007 - Chermside
Recruitment hospital [3] 0 0
Investigational Site Number 036008 - Heidelberg West
Recruitment hospital [4] 0 0
Investigational Site Number 036006 - Herston
Recruitment hospital [5] 0 0
Investigational Site Number 036001 - Nedlands
Recruitment hospital [6] 0 0
Investigational Site Number 036004 - Randwick
Recruitment hospital [7] 0 0
Investigational Site Number 036009 - Toowoomba
Recruitment hospital [8] 0 0
Investigational Site Number 036005 - Waratah
Recruitment hospital [9] 0 0
Investigational Site Number 036003 - Woodville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
4350 - Toowoomba
Recruitment postcode(s) [8] 0 0
2298 - Waratah
Recruitment postcode(s) [9] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Connecticut
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Florida
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Louisiana
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Massachusetts
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Mississippi
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New Jersey
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New York
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North Carolina
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Oklahoma
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Tennessee
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Texas
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Vermont
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United States of America
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Virginia
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Canada
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Calgary
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Canada
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Gatineau
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Greenfield Park
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Halifax
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London
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Montreal
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Ottawa
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Regina
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Sherbrooke
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St. John
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Canada
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Toronto
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France
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Bordeaux
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France
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Lille Cedex
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France
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Limoges
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Marseille
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Nantes
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Nice
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France
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Paris
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France
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Strasbourg Cedex
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France
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Toulouse Cedex 3
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Germany
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Berlin
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Germany
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Dresden
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Germany
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München
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Germany
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Schwerin
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Germany
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Würzburg
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Italy
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Ancona
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Italy
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Castellanza
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Italy
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Cefalù
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Italy
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Milano
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Poland
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Bydgoszcz
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Gdansk
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Gdynia
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Poznan
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Szczecin
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Warszawa
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Portugal
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Amadora
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Portugal
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Lisboa
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Spain
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Algorta
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Barcelona
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Madrid
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Sevilla
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Terrassa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01266525
Trial related presentations / publications
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331. doi: 10.3233/JAD-160754.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01266525