Trial Review

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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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
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Oklahoma
Country [12] 0 0
United States of America
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Tennessee
Country [13] 0 0
United States of America
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Texas
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United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Canada
State/province [16] 0 0
Calgary
Country [17] 0 0
Canada
State/province [17] 0 0
Gatineau
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Canada
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Greenfield Park
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Canada
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Halifax
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Canada
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London
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Canada
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Montreal
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Canada
State/province [22] 0 0
Ottawa
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Canada
State/province [23] 0 0
Regina
Country [24] 0 0
Canada
State/province [24] 0 0
Sherbrooke
Country [25] 0 0
Canada
State/province [25] 0 0
St. John
Country [26] 0 0
Canada
State/province [26] 0 0
Toronto
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Lille Cedex
Country [29] 0 0
France
State/province [29] 0 0
Limoges
Country [30] 0 0
France
State/province [30] 0 0
Marseille
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France
State/province [31] 0 0
Nantes
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France
State/province [32] 0 0
Nice
Country [33] 0 0
France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Strasbourg Cedex
Country [35] 0 0
France
State/province [35] 0 0
Toulouse Cedex 3
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Dresden
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Germany
State/province [39] 0 0
Schwerin
Country [40] 0 0
Germany
State/province [40] 0 0
Würzburg
Country [41] 0 0
Italy
State/province [41] 0 0
Ancona
Country [42] 0 0
Italy
State/province [42] 0 0
Castellanza
Country [43] 0 0
Italy
State/province [43] 0 0
Cefalù
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Portugal
State/province [51] 0 0
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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Spain
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Barcelona
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Madrid
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Spain
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Sevilla
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Spain
State/province [57] 0 0
Terrassa

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01266525