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

NCT ID: NCT00277810

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group Type EXPERIMENTAL

lecozotan SR (SRA-333)

Intervention Type DRUG

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

B

Group Type EXPERIMENTAL

lecozotan SR (SRA-333)

Intervention Type DRUG

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

C

Group Type EXPERIMENTAL

lecozotan SR (SRA-333)

Intervention Type DRUG

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

Interventions

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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 Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Costa Mesa, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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Orange, California, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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St Louis, Missouri, United States

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Long Branch, New Jersey, United States

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Manchester Twp., New Jersey, United States

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Albany, New York, United States

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Cedarhurst, New York, United States

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Staten Island, New York, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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Bennington, Vermont, United States

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Av. Belgrano, , Argentina

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Buenos Aires, , Argentina

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Calle Adolfo Alsina, , Argentina

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Cervino, , Argentina

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Gascon, , Argentina

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Larrea, , Argentina

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Nueva York, , Argentina

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Pilar, , Argentina

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Puerto Galván, , Argentina

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Adelaide, , Australia

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East Gosford, , Australia

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Hornsby, , Australia

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Randwick, , Australia

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Victoria, , Australia

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Edmonton, Alberta, Canada

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Medicine Hat, Alberta, Canada

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Moncton, New Brunswick, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Helsinki, , Finland

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Joensuu, , Finland

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Kuopio, , Finland

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Bordeaux, , France

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Montpellier, , France

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Nice, , France

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Toulouse, , France

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Roma, , Italy

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Roma, , Italy

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Gdansk - Wrzeszcz, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Sopot, , Poland

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Szczecin, , Poland

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Somerset West, , South Africa

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Belfast, , United Kingdom

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Glasgow, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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Swindon, , United Kingdom

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Countries

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United States Argentina Australia Canada Finland France Italy Poland South Africa Spain United Kingdom

Other Identifiers

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3098B1-203, 3098B1-204

Identifier Type: -

Identifier Source: org_study_id

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