Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:2/9/2018
Start Date:March 2014
End Date:January 2017

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Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase
inhibitors (AChEIs) for symptomatic treatment of patients with mild-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 60mg/day
as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine
at the patient's individual maintenance dose, or galantamine at the patient's individual
maintenance dose), and a 4-week safety follow-up period following study completion or
withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if
60mg/day was not well tolerated in the opinion of the investigator. The dose could be
increased again to 60mg/day, after which the dose was kept fixed for the remainder of the
study. Dose changes were permitted until Week 12 (Visit 5).

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 an AChEI.

- 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 current AChEI 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.
We found this trial at
27
sites
Lawrenceville, New Jersey 08648
1248
mi
from
Lawrenceville, NJ
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Albany, New York
1309
mi
from
Albany, NY
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Bellflower, California
1165
mi
from
Bellflower, CA
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Caulfield,
?
mi
from
Caulfield,
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633 North Carolina Highway 24
Charlotte, North Carolina 28262
960
mi
from
Charlotte, NC
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Costa Mesa, California
1160
mi
from
Costa Mesa, CA
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Danbury, Connecticut 06810
1317
mi
from
Danbury, CT
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Deerfield Beach, Florida 33064
1300
mi
from
Deerfield Beach, FL
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Elk Grove Village, Illinois 60007
598
mi
from
Elk Grove Village, IL
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Elkhart, Indiana 46514
684
mi
from
Elkhart, IN
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Farmington Hills, Michigan 48025
828
mi
from
Farmington Hills, MI
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Hialeah, Florida
1313
mi
from
Hialeah, FL
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619 Texas Street
Houston, Texas 77002
569
mi
from
Houston, TX
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Manchester, New Jersey
1268
mi
from
Manchester, NJ
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Mesa, Arizona
841
mi
from
Mesa, AZ
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Miami, Florida
1321
mi
from
Miami, FL
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Norristown, Pennsylvania
1215
mi
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Norristown, PA
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North Palm Beach, Florida 33408
1278
mi
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North Palm Beach, FL
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Norwalk, Connecticut 06851
1319
mi
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Norwalk, CT
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Oklahoma City, Oklahoma
158
mi
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Oklahoma City, OK
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Oxnard, California 93030
1216
mi
from
Oxnard, CA
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Port Charlotte, Florida
1178
mi
from
Port Charlotte, FL
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Prairie Village, Kansas 66206
193
mi
from
Prairie Village, KS
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607 Missouri Avenue
Saint Louis, Missouri 62201
420
mi
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Saint Louis, MO
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Santa Ana, California
1155
mi
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Santa Ana, CA
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Staten Island, New York
1279
mi
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Staten Island, NY
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Toms River, New Jersey
1276
mi
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Toms River, NJ
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