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

NCT02006641

Run by

H. Lundbeck A/S

People needed

858

Starts

2014-02-01

Expected to finish

2016-12-01

Last updated by the study team

2018-02-20

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

• US342 — Fayetteville, Arkansas, United States
• US322 — Anaheim, California, United States
• US305 — Carson, California, United States
• US346 — Costa Mesa, California, United States
• US327 — Fullerton, California, United States
• US315 — Lomita, California, United States
• US351 — Oceanside, California, United States
• US307 — Redlands, California, United States
• US301 — Santa Rosa, California, United States
• US337 — New London, Connecticut, United States
• US332 — Stamford, Connecticut, United States
• US308 — Delray Beach, Florida, United States
• US320 — Hallandale, Florida, United States
• US347 — Hialeah, Florida, United States
• US340 — Lake Worth, Florida, United States
• US303 — Miami, Florida, United States
• US313 — Miami, Florida, United States
• US335 — Naples, Florida, United States
• US345 — Orange City, Florida, United States
• US309 — Palm Beach Gardens, Florida, United States
• US302 — Sunrise, Florida, United States
• US304 — Atlanta, Georgia, United States
• US360 — Augusta, Georgia, United States
• US318 — Decatur, Georgia, United States
• US338 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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