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Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lecozotan SR (SRA-333)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Cholinesterase Inhibitors, Outpatients

Eligibility Criteria

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

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 Exclusion Criteria: Significant neurological disease other than AD Diagnosis of major depression History of stroke or other heart disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales

Secondary Outcome Measures

Score change from baseline to 24 weeks on functional and behavioral scales

Full Information

First Posted
January 12, 2006
Last Updated
July 1, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00277810
Brief Title
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease, Cholinesterase Inhibitors, Outpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lecozotan SR (SRA-333)
Intervention Description
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
Primary Outcome Measure Information:
Title
All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
Time Frame
6 mo extension study: week 24
Secondary Outcome Measure Information:
Title
Score change from baseline to 24 weeks on functional and behavioral scales
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Significant neurological disease other than AD Diagnosis of major depression History of stroke or other heart disease
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
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
33216
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33154
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
South Miami
State/Province
Florida
ZIP/Postal Code
33143
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
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
Buenos Aires
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
ZIP/Postal Code
950
Country
Argentina
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
East Gosford
ZIP/Postal Code
2250
Country
Australia
City
Hornsby
ZIP/Postal Code
2077
Country
Australia
City
Randwick
ZIP/Postal Code
2031
Country
Australia
City
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
ZIP/Postal Code
H4H 1R3
Country
Canada
City
Helsinki
ZIP/Postal Code
00120
Country
Finland
City
Joensuu
ZIP/Postal Code
80100
Country
Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nice
ZIP/Postal Code
06002
Country
France
City
Toulouse
ZIP/Postal Code
31300
Country
France
City
Roma
ZIP/Postal Code
00143
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Gdansk - Wrzeszcz
ZIP/Postal Code
00-282
Country
Poland
City
Krakow
ZIP/Postal Code
30-393
Country
Poland
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
City
Lodz
ZIP/Postal Code
92-216
Country
Poland
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
City
Sopot
ZIP/Postal Code
81-824
Country
Poland
City
Szczecin
ZIP/Postal Code
70-356
Country
Poland
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2197
Country
South Africa
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Belfast
ZIP/Postal Code
BT9 7BL
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S35 8QS
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
City
Swindon
ZIP/Postal Code
SN1 4JU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

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