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Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

NCT ID: NCT00895895

Last Updated: 2013-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-05-31

Brief Summary

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The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

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Detailed Description

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The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

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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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.

2

SAM-531 1.5 mg

Group Type EXPERIMENTAL

SAM-531 1.5 mg

Intervention Type DRUG

Capsules SAM-531 1.5 mg, once a day during 52 weeks.

3

SAM-531 3.0 mg

Group Type EXPERIMENTAL

SAM-531 3.0 mg

Intervention Type DRUG

Capsules SAM-531 3.0 mg, once a day during 52 weeks.

4

SAM-531 5.0 mg

Group Type EXPERIMENTAL

SAM-531 5.0 mg

Intervention Type DRUG

Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.

5

Donepezil

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.

Interventions

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Placebo

Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.

Intervention Type DRUG

SAM-531 1.5 mg

Capsules SAM-531 1.5 mg, once a day during 52 weeks.

Intervention Type DRUG

SAM-531 3.0 mg

Capsules SAM-531 3.0 mg, once a day during 52 weeks.

Intervention Type DRUG

SAM-531 5.0 mg

Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.

Intervention Type DRUG

Donepezil

Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
* Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
* Rosen Modified Hachinski Ischemic score \< or equal to 4 at screening.

Exclusion Criteria

* Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
* Current major depressive disorder or other current major psychiatric disorder.
* History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
* Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.
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

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Costa Mesa, California, United States

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Fresno, California, United States

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Garden Grove, California, United States

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Long Beach, California, United States

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Oxnard, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Atlantis, Florida, United States

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Brooksville, Florida, United States

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Hallandale, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Sunrise, 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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Atlanta, Georgia, United States

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Elk Grove Village, Illinois, United States

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Park Ridge, Illinois, United States

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St Louis, Missouri, United States

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St Louis, Missouri, 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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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Franklin, Tennessee, United States

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Bennington, Vermont, United States

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Middleton, Wisconsin, United States

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C.a.b.a., Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Ciudad de Buenos Aires, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Santiago, Chile, Chile

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Santiago, Chile, Chile

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Santiago, Chile, Chile

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Santiago, Chile, Chile

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Viña del Mar, Chile, Chile

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Bogota, Cundinamarca, Colombia

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Pereira, Risaralda Department, Colombia

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Bucamaranga, Santander Department, Colombia

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Cali, Valle del Cauca Department, Colombia

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Valle Del Cauca, , Colombia

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Shatin, N.T., Hong Kong SAR, China, Hong Kong

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Hong Kong, , Hong Kong

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Hachiōji, Tokyo, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Kanagawa, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

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Shizuoka, , Japan

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Saltillo, Coahuila, Mexico

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Aguascalientes, , Mexico

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Auckland, , New Zealand

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Hamilton, , New Zealand

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Krakow, Poland, Poland

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Poznan, Poland, Poland

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Wroclaw, Poland, Poland

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Krakow, , Poland

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Craiova, Dolj, Romania

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Timișoara, Timiș County, Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Nikolskoe Village, Gatchina District, Leningrad Region, Russia

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Kazan', , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Yaroslavl, , Russia

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Bellville, Western Cape, South Africa

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Cape Town, , South Africa

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Seongnam-si, Gyeonggi-do, South Korea

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Seoul, , South Korea

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Countries

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United States Argentina Chile Colombia Hong Kong Japan Mexico New Zealand Poland Romania Russia South Africa South Korea

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3193A1-2005&StudyName=Study%20Comparing%203%20Dosage%20Levels%20Of%20SAM-531%20In%20Outpatients%20With%20Mild%20To%20Moderate%20Alzheimer%20Disease

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1961007

Identifier Type: -

Identifier Source: secondary_id

3193A1-2005

Identifier Type: -

Identifier Source: org_study_id

NCT01312896

Identifier Type: -

Identifier Source: nct_alias

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