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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00104013




Registration number
NCT00104013
Ethics application status
Date submitted
18/02/2005
Date registered
21/02/2005
Date last updated
21/08/2008

Titles & IDs
Public title
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Scientific title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Secondary ID [1] 0 0
SR57746A
Secondary ID [2] 0 0
EFC2724
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 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 - xaliproden (SR57746A)

Treatment: Drugs: xaliproden (SR57746A)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria

- Mild to moderate degree of severity of dementia as assessed by the Mini-Mental
Status Examination score of 16 to 26 (inclusive)

- Potential participant may be treated with conventional Alzheimer's disease
therapy and must be on a stable dose for at least 6 months prior to the
randomization and during the entire study period

- Potential participant must have a reliable caregiver and must be living in a
community or in an assisted living facility

- Mother tongue is English, Spanish or French (oral and written fluency)

- Signed informed consent from potential participant or legal representative and
identified caregiver
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Potential participant with any other cause of dementia.

- Potential participant with serious health problems other than Alzheimer's disease

- Use of an investigational drug within two months prior to randomization or during this
study

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
1455
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park, New South Wales
Recruitment postcode(s) [1] 0 0
- Macquarie Park, New South Wales
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
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Causeway Bay
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Netherlands
State/province [23] 0 0
Gouda
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
South Africa
State/province [25] 0 0
Midrand
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess xaliproden's potential capacity of slowing the
deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's
disease. The patients participating in this study will take orally once daily xaliproden or
placebo (inactive substance pill).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00104013
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
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