Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• The patient has a knowledgeable and reliable caregiver.

• The patient is an outpatient.

• The patient has probable AD.

• The patient has mild to moderate AD.

• Stable treatment with donepezil.

• The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.

• The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

• The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.

• The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.

• The patient has evidence of clinically significant disease.

• The patient's donepezil therapy is likely to be interrupted or discontinued during the study.

• The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.