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Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lecozotan SR
Donepezil
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Exclusion Criteria: Use of medications for cognitive enhancement within 3 months of baseline. Significant neurologic disease other than AD that may affect cognition.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

A

B

C

D

Arm Description

Outcomes

Primary Outcome Measures

The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.

Secondary Outcome Measures

Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.

Full Information

First Posted
September 6, 2005
Last Updated
April 28, 2022
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00151398
Brief Title
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2005 (Actual)
Primary Completion Date
March 15, 2008 (Actual)
Study Completion Date
March 15, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lecozotan SR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
10 mg donepezil QD dosed up to 40 weeks
Primary Outcome Measure Information:
Title
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
Time Frame
weeks 12, 14, 26 and 40.
Secondary Outcome Measure Information:
Title
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
Time Frame
weeks 12, 14, 26 and 40.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: Use of medications for cognitive enhancement within 3 months of baseline. Significant neurologic disease other than AD that may affect cognition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
City
Manchester Twp.
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
City
Av. Belgrano
ZIP/Postal Code
2945
Country
Argentina
City
Calle Adolfo Alsina
ZIP/Postal Code
2184
Country
Argentina
City
Cervino
ZIP/Postal Code
3356
Country
Argentina
City
Galvan
ZIP/Postal Code
4102
Country
Argentina
City
Gascon
ZIP/Postal Code
450
Country
Argentina
City
Larrea
ZIP/Postal Code
1035
Country
Argentina
City
Nueva York
ZIP/Postal Code
3952
Country
Argentina
City
Pilar
Country
Argentina
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
City
Medicine Hat
State/Province
Alberta
ZIP/Postal Code
T1A 4C2
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 4B7
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
City
Westdene
State/Province
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Observatory
State/Province
Cape Town
ZIP/Postal Code
7925
Country
South Africa
City
Panorama
State/Province
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Florida
State/Province
Johannesburg
ZIP/Postal Code
1709
Country
South Africa
City
Bellville
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

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