Clinical trial NCT00895895: Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Official title: A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-08
Enrollment: 526
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB SWM Strategy at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Who Were Responders at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Oxnard
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: aTLANTIS
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Elk Grove Village
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Cedarhurst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Bennington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Middleton
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: C.a.b.a.
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Vina del Mar
country: Chile
facility: Pfizer Investigational Site
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Pereira
country: Colombia
facility: Pfizer Investigational Site
state: Risaralda
city: Bucamaranga
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Cali
country: Colombia
facility: Pfizer Investigational Site
state: Valle
city: Valle del Cauca
country: Colombia
facility: Pfizer Investigational Site
city: Shatin, N.T.
country: Hong Kong
facility: Pfizer Investigational Site
state: Hong Kong SAR, China
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Hachioji
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kanagawa
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Nagano
country: Japan
facility: Pfizer Investigational Site
city: Nagasaki
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Saltillo
country: Mexico
facility: Pfizer Investigational Site
state: Coahuila
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: Hamilton
country: New Zealand
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Craiova
country: Romania
facility: Pfizer Investigational Site
state: Dolj
city: Timisoara
country: Romania
facility: Pfizer Investigational Site
state: Timis
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Nikolskoe village
country: Russian Federation
facility: Pfizer Investigational Site
state: Gatchina district, Leningrad region
city: Kazan
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Bellville
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: