Monitoreo continuo de eficacia y seguridad de solanezumab, un anticuerpo anti-amiloide β, en pacientes con enfermedad de Alzheimer

TerminadoFase 3ClinicalTrials.gov

ID: NCT01127633Tipo: INTERVENTIONALInicio: 1 de dic de 2010Fin estimado: 1 de feb de 2017

Resumen

Este estudio es una extensión de etiqueta abierta en pacientes con enfermedad de Alzheimer que completaron la participación en el ensayo clínico de solanezumab H8A-MC-LZAM (NCT00905372) o H8A-MC-LZAN (NCT00904683).

Elegibilidad

Edad mínima: 55 YearsSexo: ALL

Criterios de inclusión

Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
Must have good vein access to administer infusions
Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Criterios de exclusión

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

Intervenciones

drug

Solanezumab

400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.

drug

Placebo

Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ciudad Automona de Buenos Aire, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Córdoba, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mendoza, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rosario, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Santa Fe, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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