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

April 28, 2022 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Av. Belgrano, Argentina, 2945
      • Calle Adolfo Alsina, Argentina, 2184
      • Cervino, Argentina, 3356
      • Galvan, Argentina, 4102
      • Gascon, Argentina, 450
      • Larrea, Argentina, 1035
      • Nueva York, Argentina, 3952
      • Pilar, Argentina
  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia, 2077
    • Victoria
      • Heidelberg Heights, Victoria, Australia, 3081
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5G 0B7
      • Medicine Hat, Alberta, Canada, T1A 4C2
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 4B7
    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C8
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
  • South Africa
    • Bloemfontein
      • Westdene, Bloemfontein, South Africa, 9301
    • Cape Town
      • Observatory, Cape Town, South Africa, 7925
      • Panorama, Cape Town, South Africa, 7500
    • Johannesburg
      • Florida, Johannesburg, South Africa, 1709
    • Western Cape
      • Bellville, Western Cape, South Africa, 7530
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Tucson, Arizona, United States, 85741
    • California
      • Costa Mesa, California, United States, 92626
      • Fresno, California, United States, 93720
      • La Jolla, California, United States, 92037
      • Orange, California, United States, 92868
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Delray Beach, Florida, United States, 33445
      • Fort Lauderdale, Florida, United States, 33321
      • Fort Myers, Florida, United States, 33916
      • Hallandale Beach, Florida, United States, 33009
      • Hialeah, Florida, United States, 33016
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33176
      • Miami Beach, Florida, United States, 33154
      • Orlando, Florida, United States, 32806
      • Sarasota, Florida, United States, 34239
      • Tampa, Florida, United States, 33617
      • West Palm Beach, Florida, United States, 33407
    • Missouri
      • Saint Louis, Missouri, United States, 63104
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
      • Manchester Twp., New Jersey, United States, 08759
    • New York
      • Albany, New York, United States, 12208
      • Cedarhurst, New York, United States, 11516
      • Lawrence, New York, United States, 11559
      • Staten Island, New York, United States, 10312
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Houston, Texas, United States, 77030
    • Vermont
      • Bennington, Vermont, United States, 05201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: 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.
Experimental: B
Drug: 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.
Experimental: C
Drug: 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.
Active Comparator: D
Drug: Donepezil
10 mg donepezil QD dosed up to 40 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
weeks 12, 14, 26 and 40.

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
Time Frame: weeks 12, 14, 26 and 40.
weeks 12, 14, 26 and 40.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2005

Primary Completion (Actual)

March 15, 2008

Study Completion (Actual)

March 15, 2008

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3098B1-201, 3098B1-202
  • B343-1057, B343-1058 (Other Identifier: Pfizer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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