Overview

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.