Skip to main content
OpenTrials
Completed

NCT Number: NCT00151398

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Av. Belgrano, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
  • Able to give informed consent. Patient' s caregiver must consent to participate in the study.

Exclusion criteria

  • Use of medications for cognitive enhancement within 3 months of baseline.
  • Significant neurologic disease other than AD that may affect cognition.

Treatment and study plan

Lecozotan SR

Drug

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.

Donepezil

Drug

10 mg donepezil QD dosed up to 40 weeks

Primary outcomes

  1. The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.

    Time frame: weeks 12, 14, 26 and 40.

Secondary outcomes

  1. Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.

    Time frame: weeks 12, 14, 26 and 40.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 8, 2005
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.