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

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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

Trial contacts and locations

56

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Data sourced from clinicaltrials.gov

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