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

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT01955161

Run by

H. Lundbeck A/S

People needed

933

Starts

2013-10-01

Expected to finish

2016-07-01

Last updated by the study team

2017-09-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• US012 — Phoenix, Arizona, United States
• US024 — Little Rock, Arkansas, United States
• US053 — Glendale, California, United States
• US023 — Imperial, California, United States
• US015 — La Jolla, California, United States
• US045 — Long Beach, California, United States
• US002 — Los Angeles, California, United States
• US058 — San Francisco, California, United States
• US018 — Santa Ana, California, United States
• US060 — Denver, Colorado, United States
• US042 — Boca Raton, Florida, United States
• US021 — Bradenton, Florida, United States
• US050 — Brooksville, Florida, United States
• US019 — Orlando, Florida, United States
• US038 — Port Charlotte, Florida, United States
• US001 — West Palm Beach, Florida, United States
• US020 — Atlanta, Georgia, United States
• US048 — Kailua, Hawaii, United States
• US030 — Chicago, Illinois, United States
• US051 — Joliet, Illinois, United States
• US040 — Indianapolis, Indiana, United States
• US036 — Freeport, Maine, United States
• US032 — Newton, Massachusetts, United States
• US035 — Kalamazoo, Michigan, United States
• US027 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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