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 |
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).
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).
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
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