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

July 1, 2020 updated by: Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2
  • Phase 3

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

      • Av. Belgrano, Argentina, 2945
      • Buenos Aires, Argentina
      • Calle Adolfo Alsina, Argentina, 2184
      • Cervino, Argentina, 3356
      • Galvan, Argentina, 4102
      • Gascon, Argentina, 450
      • Larrea, Argentina, 1035
      • Nueva York, Argentina, 3952
      • Pilar, Argentina, 950
      • Adelaide, Australia, 5000
      • East Gosford, Australia, 2250
      • Hornsby, Australia, 2077
      • Randwick, Australia, 2031
      • Victoria, Australia, 3081
    • 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, H4H 1R3
      • Helsinki, Finland, 00120
      • Joensuu, Finland, 80100
      • Kuopio, Finland, 70211
      • Bordeaux, France, 33076
      • Montpellier, France, 34295
      • Nice, France, 06002
      • Toulouse, France, 31300
      • Roma, Italy, 00168
      • Roma, Italy, 00143
      • Gdansk - Wrzeszcz, Poland, 00-282
      • Krakow, Poland, 31-530
      • Krakow, Poland, 30-393
      • Lodz, Poland, 92-216
      • Lublin, Poland, 20-022
      • Sopot, Poland, 81-824
      • Szczecin, Poland, 70-356
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 7500
      • Johannesburg, South Africa, 2197
      • Somerset West, South Africa, 7130
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08025
      • Barcelona, Spain, 08014
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Belfast, United Kingdom, BT9 7BL
      • Glasgow, United Kingdom, G20 0XA
      • Sheffield, United Kingdom, S35 8QS
      • Southampton, United Kingdom, SO30 3JB
      • Swindon, United Kingdom, SN1 4JU
    • 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
      • 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, 33216
      • Miami, Florida, United States, 33176
      • Miami Beach, Florida, United States, 33154
      • Orlando, Florida, United States, 32806
      • Sarasota, Florida, United States, 34239
      • South Miami, Florida, United States, 33143
      • 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
      • 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 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Experimental: B
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
Experimental: C
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 mo extension study: week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Score change from baseline to 24 weeks on functional and behavioral scales
Time Frame: week 24
week 24

Collaborators and Investigators

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

Sponsor

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

March 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

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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