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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00895895




Registration number
NCT00895895
Ethics application status
Date submitted
7/05/2009
Date registered
8/05/2009
Date last updated
31/01/2013

Titles & IDs
Public title
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Scientific 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
Secondary ID [1] 0 0
B1961007
Secondary ID [2] 0 0
3193A1-2005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - SAM-531 1.5 mg
Treatment: Drugs - SAM-531 3.0 mg
Treatment: Drugs - SAM-531 5.0 mg
Treatment: Drugs - Donepezil

Placebo comparator: 1 - Placebo

Experimental: 2 - SAM-531 1.5 mg

Experimental: 3 - SAM-531 3.0 mg

Experimental: 4 - SAM-531 5.0 mg

Active comparator: 5 - Donepezil


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

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

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

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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
Timepoint [7] 0 0
Baseline, Week 24
Secondary outcome [8] 0 0
Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Change From Baseline in CANTAB SWM Strategy at Week 24
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
Timepoint [12] 0 0
Baseline, Week 24
Secondary outcome [13] 0 0
Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
Timepoint [13] 0 0
Baseline, Week 24
Secondary outcome [14] 0 0
Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
Timepoint [14] 0 0
Baseline, Week 24
Secondary outcome [15] 0 0
Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
Timepoint [15] 0 0
Baseline, Week 24
Secondary outcome [16] 0 0
Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
Timepoint [16] 0 0
Baseline, Week 24
Secondary outcome [17] 0 0
Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
Timepoint [17] 0 0
Baseline, Week 24
Secondary outcome [18] 0 0
Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
Timepoint [18] 0 0
Baseline, Week 24
Secondary outcome [19] 0 0
Percentage of Participants Who Were Responders at Week 24
Timepoint [19] 0 0
Week 24

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
526
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
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Oregon
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United States of America
State/province [12] 0 0
Pennsylvania
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United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad de Buenos Aires
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
Chile
State/province [19] 0 0
Vina del Mar
Country [20] 0 0
Colombia
State/province [20] 0 0
Cundinamarca
Country [21] 0 0
Colombia
State/province [21] 0 0
Risaralda
Country [22] 0 0
Colombia
State/province [22] 0 0
Santander
Country [23] 0 0
Colombia
State/province [23] 0 0
Valle
Country [24] 0 0
Colombia
State/province [24] 0 0
Valle del Cauca
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hong Kong SAR, China
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Hong Kong
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Hiroshima
Country [31] 0 0
Japan
State/province [31] 0 0
Kanagawa
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Japan
State/province [32] 0 0
Kumamoto
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Japan
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Kyoto
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Japan
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Nagano
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Japan
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Nagasaki
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Japan
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Shizuoka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Coahuila
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Mexico
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Aguascalientes
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Wroclaw
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Romania
State/province [46] 0 0
Dolj
Country [47] 0 0
Romania
State/province [47] 0 0
Timis
Country [48] 0 0
Romania
State/province [48] 0 0
Bucuresti
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Gatchina district, Leningrad region
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Kazan
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
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Novosibirsk
Country [53] 0 0
Russian Federation
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Saint-Petersburg
Country [54] 0 0
Russian Federation
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Smolensk
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Russian Federation
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Yaroslavl
Country [56] 0 0
South Africa
State/province [56] 0 0
Free State
Country [57] 0 0
South Africa
State/province [57] 0 0
Gauteng
Country [58] 0 0
South Africa
State/province [58] 0 0
Western Cape
Country [59] 0 0
South Africa
State/province [59] 0 0
Cape Town

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00895895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00895895