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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01955161Tipo: INTERVENTIONALInicio: 1 de oct de 2013Fin estimado: 1 de jul de 2016

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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 30 mg/day or 60 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.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Placebo

Once daily, matching placebo capsules, orally

drug

Idalopirdine

Once daily, encapsulated tablets, orally

Ubicaciones

AR002

Buenos Aires, Argentina

AR003

Buenos Aires, Argentina

AR006

Buenos Aires, Argentina

AR007

Buenos Aires, Argentina

AR009

Córdoba, Argentina

AR004

Mar del Plata, Argentina

AR005

Mendoza, Argentina

AR008

Mendoza, Argentina

AR010

Rosario, Argentina

Patrocinadores

PrincipalH. Lundbeck A/S

ColaboradorOtsuka Pharmaceutical Co., Ltd.

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