Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).

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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 / Phase 3

Primary location

Av. Belgrano, Argentina

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of probable Alzheimer's disease
Current use of cholinesterase inhibitor
Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study

Exclusion criteria

Significant neurological disease other than AD
Diagnosis of major depression
History of stroke or other heart disease

Treatment and study plan

lecozotan SR (SRA-333)

Drug

one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr

Primary outcomes

All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales

Time frame: 6 mo extension study: week 24

Secondary outcomes

Score change from baseline to 24 weeks on functional and behavioral scales

Time frame: week 24

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A 6-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 Treated With a Cholinesterase Inhibitor

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jan 16, 2006
Registry last updated: Jul 7, 2020

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.

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

Completed