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

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: lecozotan SR (SRA-333)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00277810

3098B1-203, 3098B1-204

Details and patient eligibility

About

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).

Enrollment: 250 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: lecozotan SR (SRA-333)

B

Experimental group

Treatment:

Drug: lecozotan SR (SRA-333)

C

Experimental group

Treatment:

Drug: lecozotan SR (SRA-333)