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Long-term Safety and Tolerabi...

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

NCT ID: NCT02079246

Last Updated: 2018-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-07

Study Completion Date

2017-07-06

Brief Summary

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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).

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Detailed Description

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This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641).

Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Idalopirdine (Lu AE58054) 60 mg

Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.

Group Type EXPERIMENTAL

Idalopirdine 60 mg

Intervention Type DRUG

once daily, encapsulated tablets, orally

Idalopirdine 60 mg + memantine

Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.

Group Type EXPERIMENTAL

Idalopirdine 60 mg

Intervention Type DRUG

once daily, encapsulated tablets, orally

Interventions

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Idalopirdine 60 mg

once daily, encapsulated tablets, orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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US027

Birmingham, Alabama, United States

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US012

Phoenix, Arizona, United States

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US338

Phoenix, Arizona, United States

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US024

Little Rock, Arkansas, United States

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US351

Carlsbad, California, United States

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US346

Costa Mesa, California, United States

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US327

Fullerton, California, United States

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Imperial, California, United States

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Long Beach, California, United States

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Redlands, California, United States

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San Francisco, California, United States

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Santa Ana, California, United States

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US301

Santa Rosa, California, United States

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Bradenton, Florida, United States

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Brooksville, Florida, United States

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US308

Delray Beach, Florida, United States

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US320

Hallandale, Florida, United States

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US347

Hialeah, Florida, United States

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US340

Lake Worth, Florida, United States

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US303

Miami, Florida, United States

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US313

Miami, Florida, United States

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US345

Orange City, Florida, United States

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Orlando, Florida, United States

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US309

Palm Beach Gardens, Florida, United States

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Port Charlotte, Florida, United States

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Sunrise, Florida, United States

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US304

Atlanta, Georgia, United States

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US360

Augusta, Georgia, United States

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US048

Kailua, Hawaii, United States

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US030

Chicago, Illinois, United States

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US040

Indianapolis, Indiana, United States

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US334

Lake Charles, Louisiana, United States

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US036

Freeport, Maine, United States

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US344

Boston, Massachusetts, United States

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US035

Kalamazoo, Michigan, United States

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US310

Saint Paul, Minnesota, United States

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US041

Flowood, Mississippi, United States

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US321

Hattiesburg, Mississippi, United States

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US339

Paterson, New Jersey, United States

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US046

Princeton, New Jersey, United States

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US028

Toms River, New Jersey, United States

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US044

Toms River, New Jersey, United States

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US014

Manhasset, New York, United States

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US029

New York, New York, United States

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US312

Staten Island, New York, United States

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US316

Charlotte, North Carolina, United States

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US336

Winston-Salem, North Carolina, United States

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US007

Centerville, Ohio, United States

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US323

Cincinnati, Ohio, United States

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US006

Columbus, Ohio, United States

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US306

Columbus, Ohio, United States

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US352

Lakewood, Ohio, United States

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US333

Oklahoma City, Oklahoma, United States

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US026

Portland, Oregon, United States

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US057

Jenkintown, Pennsylvania, United States

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US324

Pittsburgh, Pennsylvania, United States

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US341

Pittsburgh, Pennsylvania, United States

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US319

Port Royal, South Carolina, United States

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US356

Cordova, Tennessee, United States

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US343

Fort Worth, Texas, United States

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US354

Houston, Texas, United States

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US047

Arlington, Virginia, United States

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US025

Madison, Wisconsin, United States

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US004

Milwaukee, Wisconsin, United States

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AR303

Banfield, , Argentina

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AR007

Buenos Aires, , Argentina

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