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A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease

NCT00912288 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2012-10-02

Study results available
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Summary

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Dimebon 20 mg po TID

Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks

DRUG

Placebo po TID

Placebo (matched to Dimebon) po for 26 weeks

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

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
2009-09-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Canada
  • Germany
  • Hungary
  • Portugal
  • Slovakia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

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 NCT00912288 on ClinicalTrials.gov