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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85004 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00895895
Pfizer
Terminated
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

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Descriptive Information
Brief Title  ICMJE Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionThe 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Placebo
    Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
  • Drug: SAM-531 1.5 mg
    Capsules SAM-531 1.5 mg, once a day during 52 weeks.
  • Drug: SAM-531 3.0 mg
    Capsules SAM-531 3.0 mg, once a day during 52 weeks.
  • Drug: SAM-531 5.0 mg
    Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    SAM-531 1.5 mg
    Intervention: Drug: SAM-531 1.5 mg
  • Experimental: 3
    SAM-531 3.0 mg
    Intervention: Drug: SAM-531 3.0 mg
  • Experimental: 4
    SAM-531 5.0 mg
    Intervention: Drug: SAM-531 5.0 mg
  • Active Comparator: 5
    Donepezil
    Intervention: Drug: Donepezil
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 10, 2011)
526
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2009)
460
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Colombia,   Hong Kong,   Japan,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00895895
Other Study ID Numbers  ICMJE 3193A1-2005
B1961007
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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