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Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

NCT00151398 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2022-05-06

No results posted yet for this study

Summary

The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.

Conditions

  • Alzheimer Disease

Interventions

DRUG

lecozotan SR

evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.

DRUG

Donepezil

10 mg donepezil QD dosed up to 40 weeks

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-06
Primary Completion
2008-03-15
Completion
2008-03-15

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • South Africa

Study Locations

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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 NCT00151398 on ClinicalTrials.gov