Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Public ClinicalTrials.gov record NCT00895895. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00895895
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 526 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- SAM-531 1.5 mg Drug
- SAM-531 3.0 mg Drug
- SAM-531 5.0 mg Drug
- Donepezil Drug
Drug
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2009 (Type not available)
- Primary completion
- May 2011 (Actual)
- Completion
- May 2011 (Actual)
- Last update posted
- Jan 31, 2013
2009 – 2011
United States locations
- U.S. sites
- 37
- U.S. states
- 15
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85004 | — |
| Pfizer Investigational Site | Phoenix | Arizona | 85050 | — |
| Pfizer Investigational Site | Costa Mesa | California | 92626 | — |
| Pfizer Investigational Site | Fresno | California | 93720 | — |
| Pfizer Investigational Site | Garden Grove | California | 92845 | — |
| Pfizer Investigational Site | Long Beach | California | 90806 | — |
| Pfizer Investigational Site | Oxnard | California | 93030 | — |
| Pfizer Investigational Site | Denver | Colorado | 80218 | — |
| Pfizer Investigational Site | Denver | Colorado | 80239 | — |
| Pfizer Investigational Site | Atlantis | Florida | 33462 | — |
| Pfizer Investigational Site | Brooksville | Florida | 34601 | — |
| Pfizer Investigational Site | Hallandale | Florida | 33009 | — |
| Pfizer Investigational Site | Miami | Florida | 33180 | — |
| Pfizer Investigational Site | Naples | Florida | 34102 | — |
| Pfizer Investigational Site | Plantation | Florida | 33317 | — |
| Pfizer Investigational Site | St. Petersburg | Florida | 33702 | — |
| Pfizer Investigational Site | St. Petersburg | Florida | 33709 | — |
| Pfizer Investigational Site | Sunrise | Florida | 33351 | — |
| Pfizer Investigational Site | Tampa | Florida | 33613 | — |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | — |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | — |
| Pfizer Investigational Site | Elk Grove Village | Illinois | 60007 | — |
| Pfizer Investigational Site | Park Ridge | Illinois | 60068 | — |
| Pfizer Investigational Site | St Louis | Missouri | 63104 | — |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | — |
| Pfizer Investigational Site | Cedarhurst | New York | 11516 | — |
| Pfizer Investigational Site | Staten Island | New York | 10312 | — |
| Pfizer Investigational Site | Toledo | Ohio | 43623 | — |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73116 | — |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74104 | — |
| Pfizer Investigational Site | Portland | Oregon | 97210 | — |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18104 | — |
| Pfizer Investigational Site | Franklin | Tennessee | 37067 | — |
| Pfizer Investigational Site | Bennington | Vermont | 05201 | — |
| Pfizer Investigational Site | Middleton | Wisconsin | 53562 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00895895, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2013 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00895895 live on ClinicalTrials.gov.