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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/NCT00277810




Registration number
NCT00277810
Ethics application status
Date submitted
12/01/2006
Date registered
16/01/2006
Date last updated
7/07/2020

Titles & IDs
Public title
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
Scientific title
A 6-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 Treated With a Cholinesterase Inhibitor
Secondary ID [1] 0 0
3098B1-203, 3098B1-204
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 (SRA-333)

Experimental: A -

Experimental: B -

Experimental: C -


Treatment: Drugs: lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
Timepoint [1] 0 0
6 mo extension study: week 24
Secondary outcome [1] 0 0
Score change from baseline to 24 weeks on functional and behavioral scales
Timepoint [1] 0 0
week 24

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

- Current use of cholinesterase inhibitor

- Able to give signed and dated informed consent and lives with appropriate caregiver at
home or in community dwelling with caregiver accompanying patient to all visits and
visiting patient at least daily for duration of the study
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant neurological disease other than AD

- Diagnosis of major depression

- History of stroke or other heart disease

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- East Gosford
Recruitment hospital [3] 0 0
- Hornsby
Recruitment hospital [4] 0 0
- Randwick
Recruitment hospital [5] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - East Gosford
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
3081 - Victoria
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
State/province [2] 0 0
California
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Florida
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United States of America
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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United States of America
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Vermont
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Argentina
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Av. Belgrano
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Buenos Aires
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Argentina
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Calle Adolfo Alsina
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Argentina
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Cervino
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Galvan
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Gascon
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Argentina
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Larrea
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Argentina
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Nueva York
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Argentina
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Pilar
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Canada
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Alberta
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Helsinki
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Finland
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Joensuu
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Finland
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Kuopio
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France
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Bordeaux
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France
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Montpellier
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France
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Nice
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France
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Toulouse
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Italy
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Roma
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Poland
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Gdansk - Wrzeszcz
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Poland
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Krakow
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Lodz
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Lublin
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Sopot
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Szczecin
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Somerset West
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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Belfast
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United Kingdom
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Glasgow
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
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Swindon

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of
lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate
Alzheimer's disease (AD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00277810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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