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

Wyeth

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Donepezil; Drug: lecozotan SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151398

3098B1-201, 3098B1-202

B343-1057, B343-1058 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

229 participants in 4 patient groups

A

Experimental group

Treatment:

Drug: lecozotan SR

B

Experimental group

Treatment:

Drug: lecozotan SR

C

Experimental group

Treatment:

Drug: lecozotan SR

D

Active Comparator group

Treatment:

Drug: Donepezil