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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00277810

Enrollment

250

Registered

2006-01-16

Start date

2006-03-31

Completion date

2008-06-30

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease, Cholinesterase Inhibitors, Outpatients

Brief summary

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).

Interventions

DRUGlecozotan SR (SRA-333)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales	6 mo extension study: week 24

Secondary

Measure	Time frame
Score change from baseline to 24 weeks on functional and behavioral scales	week 24

Countries

Argentina, Australia, Canada, Finland, France, Italy, Poland, South Africa, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026