Resumen

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Descripción detallada

TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) and the presence of AD pathology.

Elegibilidad

Edad mínima: 60 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
A MMSE score of 20 to 28 (inclusive) at screening visit.
Meet amyloid scan (central read) criteria.
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments
AEs and concomitant medications
CDR, and
ADCS-ADL
Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Criterios de exclusión

Has significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of \<24 months.
History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
Contraindication to MRI or PET scans.

Ubicaciones

Hospital Italiano de Buenos Aires

ABB, Argentina

SUSPENDED

Clinica Privada Banfield

Banfield, Argentina

SUSPENDED

Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)

Buenos Aires, Argentina

SUSPENDED

Stat Research S.A.

Buenos Aires, Argentina

SUSPENDED

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

SUSPENDED

CIPREC

Buenos Aires, Argentina

SUSPENDED

Mautalen Salud e Investigación

Buenos Aires, Argentina

SUSPENDED

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

SUSPENDED

Centro Médico Arsema

Buenos Aires, Argentina

SUSPENDED

Instituto Geriatrico Nuestra Señora de Las Nieves

Buenos Aires, Argentina

SUSPENDED

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)

Buenos Aires, Argentina

SUSPENDED

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

SUSPENDED

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Argentina

SUSPENDED

INSA Instituto de Neurociencia San Agustin

La Plata, Argentina

SUSPENDED

Instituto De Investigaciones Clinicas Quilmes

Quilmes, Argentina

SUSPENDED

INECO Neurociencias Oroño

Rosario, Argentina

SUSPENDED

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Donanemab

Placebo

Ubicaciones

Hospital Italiano de Buenos Aires

Clinica Privada Banfield

Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)

Stat Research S.A.

Centro de Investigaciones Metabólicas (CINME)

CIPREC

Mautalen Salud e Investigación

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Centro Médico Arsema

Instituto Geriatrico Nuestra Señora de Las Nieves

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

IDIM - Instituto de Investigaciones Metabólicas

INSA Instituto de Neurociencia San Agustin

Instituto De Investigaciones Clinicas Quilmes

INECO Neurociencias Oroño

Patrocinadores

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact