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

Last updated on August 9, 2018

FOR MORE INFORMATION
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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Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
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
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).
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
526
May 2011
May 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Colombia,   Hong Kong,   Japan,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   South Africa,   United States
 
 
NCT00895895
3193A1-2005
B1961007
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

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

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