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

NCT00895895 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2013-01-31

Study results available
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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).

Conditions

  • Alzheimer Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Argentina
  • Chile
  • Colombia
  • Hong Kong
  • Japan
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895895 on ClinicalTrials.gov