Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

Key facts

Study ID

NCT02079246

Run by

H. Lundbeck A/S

People needed

1463

Starts

2014-04-07

Expected to finish

2017-07-06

Last updated by the study team

2018-08-10

Who can join

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

You may qualify if…

• the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641
• For patients in the OLEX-MEM:
• The patient has completed Visit 6 (Week 28) of the OLEX.
• The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.

You may not qualify if…

• The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
• The patient has experienced seizures before Completion Visit in the lead-in study.
• The patient has evidence of clinically significant disease.
• The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
• The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).
• Other protocol-defined inclusion and exclusion criteria may apply.

Where it is running

• US012 — Phoenix, Arizona, United States
• US338 — Phoenix, Arizona, United States
• US024 — Little Rock, Arkansas, United States
• US351 — Carlsbad, California, United States
• US346 — Costa Mesa, California, United States
• US327 — Fullerton, California, United States
• US023 — Imperial, California, United States
• US045 — Long Beach, California, United States
• US307 — Redlands, California, United States
• US058 — San Francisco, California, United States
• US018 — Santa Ana, California, United States
• US301 — Santa Rosa, California, United States
• US021 — Bradenton, Florida, United States
• US050 — Brooksville, Florida, 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
• US345 — Orange City, Florida, United States
• US019 — Orlando, Florida, United States
• US309 — Palm Beach Gardens, Florida, United States
• US038 — Port Charlotte, Florida, United States
• US027 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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