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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/NCT00151398




Registration number
NCT00151398
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
6/05/2022

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
Sex
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
6/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2008
Sample size
Target
Accrual to date
Final
229
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00151398