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
Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Albany, New York
2353
mi
from 98109
Albany, NY
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Bellflower, California
975
mi
from 98109
Bellflower, CA
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Caulfield,
?
mi
from 98109
Caulfield,
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633 North Carolina Highway 24
Charlotte, North Carolina 28262
2282
mi
from 98109
Charlotte, NC
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Costa Mesa, California
993
mi
from 98109
Costa Mesa, CA
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Danbury, Connecticut 06810
2405
mi
from 98109
Danbury, CT
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Deerfield Beach, Florida 33064
2709
mi
from 98109
Deerfield Beach, FL
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Elk Grove Village, Illinois 60007
1713
mi
from 98109
Elk Grove Village, IL
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Elkhart, Indiana 46514
1816
mi
from 98109
Elkhart, IN
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Farmington Hills, Michigan 48025
1913
mi
from 98109
Farmington Hills, MI
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Hialeah, Florida
2724
mi
from 98109
Hialeah, FL
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619 Texas Street
Houston, Texas 77002
1890
mi
from 98109
Houston, TX
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Lawrenceville, New Jersey 08648
2382
mi
from 98109
Lawrenceville, NJ
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Manchester, New Jersey
2411
mi
from 98109
Manchester, NJ
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Mesa, Arizona
1124
mi
from 98109
Mesa, AZ
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Miami, Florida
2731
mi
from 98109
Miami, FL
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Norristown, Pennsylvania
2359
mi
from 98109
Norristown, PA
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North Palm Beach, Florida 33408
2686
mi
from 98109
North Palm Beach, FL
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Norwalk, Connecticut 06851
2416
mi
from 98109
Norwalk, CT
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Oxnard, California 93030
942
mi
from 98109
Oxnard, CA
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Port Charlotte, Florida
2589
mi
from 98109
Port Charlotte, FL
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Prairie Village, Kansas 66206
1504
mi
from 98109
Prairie Village, KS
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607 Missouri Avenue
Saint Louis, Missouri 62201
1722
mi
from 98109
Saint Louis, MO
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Santa Ana, California
987
mi
from 98109
Santa Ana, CA
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Staten Island, New York
2399
mi
from 98109
Staten Island, NY
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Toms River, New Jersey
2418
mi
from 98109
Toms River, NJ
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