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

NCT00895895 | Terminated Phase 2 Results DMC

• 2 other identifiers: 3193A1-2005B1961007
• Study Type: interventional
• Target: 526
• Locations: 13 countries
• Sites: 96

Brief Summary

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).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24

  14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.

  Baseline, Week 24

Secondary Outcomes (19)

• Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24

  Baseline, Week 24

• Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24

  Baseline, Week 24

• Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24

  Baseline, Week 24

• Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24

  Baseline, Week 24

• Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24

  Baseline, Week 24

Study Arms (5)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

SAM-531 1.5 mg

Drug: SAM-531 1.5 mg

3

EXPERIMENTAL

SAM-531 3.0 mg

Drug: SAM-531 3.0 mg

4

EXPERIMENTAL

SAM-531 5.0 mg

Drug: SAM-531 5.0 mg

5

ACTIVE COMPARATOR

Donepezil

Drug: Donepezil

Interventions

Placebo DRUG

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

1

SAM-531 1.5 mg DRUG

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

2

SAM-531 3.0 mg DRUG

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

3

SAM-531 5.0 mg DRUG

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

4

Donepezil 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.

5

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (96)

Pfizer Investigational Site

Phoenix, Arizona, 85004, United States

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Phoenix, Arizona, 85050, United States

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Costa Mesa, California, 92626, United States

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Fresno, California, 93720, United States

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Garden Grove, California, 92845, United States

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Long Beach, California, 90806, United States

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Oxnard, California, 93030, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80239, United States

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Atlantis, Florida, 33462, United States

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Brooksville, Florida, 34601, United States

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Hallandale, Florida, 33009, United States

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Miami, Florida, 33180, United States

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Naples, Florida, 34102, United States

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Plantation, Florida, 33317, United States

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St. Petersburg, Florida, 33702, United States

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St. Petersburg, Florida, 33709, United States

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Sunrise, Florida, 33351, United States

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Tampa, Florida, 33613, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30308, United States

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Elk Grove Village, Illinois, 60007, United States

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Park Ridge, Illinois, 60068, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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Cedarhurst, New York, 11516, United States

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Staten Island, New York, 10312, United States

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Toledo, Ohio, 43623, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Oklahoma City, Oklahoma, 73116, United States

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Tulsa, Oklahoma, 74104, United States

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Portland, Oregon, 97210, United States

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Allentown, Pennsylvania, 18104, United States

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Franklin, Tennessee, 37067, United States

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Bennington, Vermont, 05201, United States

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Middleton, Wisconsin, 53562, United States

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C.a.b.a., Buenos Aires, C1126AAB, Argentina

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Caba, Buenos Aires, 1022, Argentina

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Ciudad de Buenos Aires, 1022, Argentina

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Ciudad de Buenos Aires, C1425BWO, Argentina

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Santiago, Chile, 7500922, Chile

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Santiago, Chile, 7530193, Chile

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Santiago, Chile, 7630000, Chile

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Santiago, Chile, 8330838, Chile

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Viña del Mar, Chile, 2520997, 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, 25000, Mexico

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Aguascalientes, 20127, Mexico

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Auckland, 0622, New Zealand

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Hamilton, 3240, New Zealand

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Krakow, Poland, 31-531, Poland

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Poznan, Poland, 61-289, Poland

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Wroclaw, Poland, 50-088, Poland

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Krakow, 31-531, Poland

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Craiova, Dolj, 200317, Romania

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Timișoara, Timiș County, 300736, Romania

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Bucharest, 010825, Romania

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Bucharest, 011241, Romania

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Bucharest, 041914, Romania

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Bucharest, 050098, Romania

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Nikolskoe Village, Gatchina District, Leningrad Region, 188357, Russia

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Kazan', 420101, Russia

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Moscow, 115522, Russia

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Moscow, 123182, Russia

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Novosibirsk, 630054, Russia

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Saint Petersburg, 190005, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 198103, Russia

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Smolensk, 214018, Russia

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Yaroslavl, 150030, Russia

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Bloemfontein, Free State, 9301, South Africa

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Johannesburg, Gauteng, 2196, South Africa

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Pretoria, Gauteng, 0041, South Africa

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Bellville, Western Cape, 7530, South Africa

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Cape Town, 7530, South Africa

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Seongnam-si, Gyeonggi-do, 463-707, South Korea

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Seoul, 138-736, South Korea

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Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

SAM-531; Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Study terminated early due to futility. Period 2 events include those that started in Period 2 or started in Period 1 and continued in to Period 2.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 31, 2013
• Results First Posted: January 31, 2013

Record last verified: 2012-12

Locations

RU (12); US (37); ME (2); KR (2); JP (10); AR (4); CL (5); NZ (2); ZA (5); PL (4); CO (5); HK (2); RO (6)