Estudio AZ3110866, un estudio de dosis fija de SB-742457 versus placebo como complemento al tratamiento existente con donepezilo en sujetos con enfermedad de Alzheimer leve a moderada

CompletadoFase 2ClinicalTrials.gov

ID: NCT00710684Tipo: INTERVENTIONALInicio: 1 de jul de 2008Fin estimado: 16 de nov de 2010

Resumen

El estudio está diseñado para investigar la seguridad y eficacia de SB-742457 como complemento al tratamiento estable con donepezilo en sujetos con enfermedad de Alzheimer leve a moderada.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Subjects and their caregivers must provide informed consent prior to study entry.
Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control.
Subjects must have adequate blood pressure and laboratory values.

Criterios de exclusión

Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate.
Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.

Intervenciones

drug

SB-742457 15mg

SB-742457 - 15mg added to existing donepezil treatment

drug

SB-742457 35mg

SB-742457 - 35mg added to existing donepezil

drug

Placebo

Placebo added to existing donepezil

drug

donepezil 5-10mg

existing donepezil treatment

Ubicaciones

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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