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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00151398




Registration number
NCT00151398
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
11/02/2013

Titles & IDs
Public title
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
Scientific title
A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.
Secondary ID [1] 0 0
B343-1057, B343-1058
Secondary ID [2] 0 0
3098B1-201, 3098B1-202
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 - lecozotan SR
Treatment: Drugs - Donepezil

Experimental: A -

Experimental: B -

Experimental: C -

Active Comparator: D -


Treatment: Drugs: lecozotan SR
evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks.
Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.

Treatment: Drugs: Donepezil
10 mg donepezil QD dosed up to 40 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
Timepoint [1] 0 0
weeks 12, 14, 26 and 40.
Secondary outcome [1] 0 0
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
Timepoint [1] 0 0
weeks 12, 14, 26 and 40.

Eligibility
Key inclusion criteria
- Diagnosis of probable AD according to the NINCDS-ADRDA criteria.

- Able to give informed consent. Patient' s caregiver must consent to participate in the
study.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of medications for cognitive enhancement within 3 months of baseline.

- Significant neurologic disease other than AD that may affect cognition.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Hornsby
Recruitment hospital [2] 0 0
- Heidelberg Heights
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg Heights
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
Argentina
State/province [15] 0 0
Av. Belgrano
Country [16] 0 0
Argentina
State/province [16] 0 0
Calle Adolfo Alsina
Country [17] 0 0
Argentina
State/province [17] 0 0
Cervino
Country [18] 0 0
Argentina
State/province [18] 0 0
Galvan
Country [19] 0 0
Argentina
State/province [19] 0 0
Gascon
Country [20] 0 0
Argentina
State/province [20] 0 0
Larrea
Country [21] 0 0
Argentina
State/province [21] 0 0
Nueva York
Country [22] 0 0
Argentina
State/province [22] 0 0
Pilar
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
New Brunswick
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Saskatchewan
Country [28] 0 0
South Africa
State/province [28] 0 0
Bloemfontein
Country [29] 0 0
South Africa
State/province [29] 0 0
Cape Town
Country [30] 0 0
South Africa
State/province [30] 0 0
Johannesburg
Country [31] 0 0
South Africa
State/province [31] 0 0
Western Cape

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of
lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
Trial website
https://clinicaltrials.gov/show/NCT00151398
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
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
Other publications