Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:2/22/2018
Start Date:February 2014
End Date:December 2016

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Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

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

The study consisted of a screening period (up to 2-week period from screening to
randomization), a 24-week double-blind treatment period with placebo or idalopirdine 10
mg/day or 30 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety
follow-up period following study completion or withdrawal from treatment.

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.
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Miami, Florida 33137
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Allentown, Pennsylvania 18104
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Anaheim, California 92804
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Atlanta, Georgia 30308
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Augusta, Georgia
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Banfield,
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Belmont, Massachusetts 02478
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344 Massachusetts Avenue
Boston, Massachusetts 02118
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Carson, California 90746
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Charlotte, North Carolina 28211
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Cincinnati, Ohio 45219
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349 Ohio 3
Cleveland, Ohio 44195
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306 South Ohio Avenue
Columbus, Ohio 43205
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Cordova, Tennessee
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Costa Mesa, California 92626
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Creve Coeur, Missouri 63141
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Decatur, Georgia 30033
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Delray Beach, Florida 33445
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Fayetteville, Arkansas
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Fort Worth, Texas 76107
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Fullerton, California 92835
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Hallandale Beach, Florida 33009
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321 Mississippi Avenue
Hattiesburg, Mississippi 39401
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347 Hialeah Drive
Hialeah, Florida 33016
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12300 North Freeway
Houston, Texas 77060
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334 Lakeshore Drive
Lake Charles, Louisiana 70629
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340 Lake Avenue
Lake Worth, Florida 33449
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352 West Ohio Place
Lakewood, Ohio 80226
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Lomita, California 90717
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339 Manchester Boulevard
Manchester, New Jersey 08759
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Miami, Florida 33186
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Naples, Florida 34102
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337 Connecticut Avenue
New London, Connecticut 06320
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Oceanside, California 92056
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333 North Oklahoma Avenue
Oklahoma City, Oklahoma 73116
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345 Florida Avenue
Orange City, Florida 32763
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Palm Beach Gardens, Florida 33418
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Phoenix, Arizona 85013
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Pittsburgh, Pennsylvania 15260
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341 Penn Circle
Pittsburgh, Pennsylvania 15206
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Port Royal, South Carolina 29935
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Reading, Pennsylvania 19605
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Redlands, California 92374
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800 South Washington Avenue
Saint Paul, Minnesota 55401
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Santa Rosa, California 95405
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Staten Island, New York 10312
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Sunrise, Florida 33019
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