Suspendido

PRIMEA Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)

+ Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)

+ Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)

Medicamento
Quiénes están siendo reclutados

Trastornos Mentales+3

+ Enfermedades del Cerebro

+ Enfermedades del Sistema Nervioso Central

De 50 a 90 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase 1
Intervencional
Inicio del estudio: octubre de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalBiogen
Última actualización: 3 de agosto de 2020
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 5 de octubre de 2012

Fecha en la que se inscribió al primer participante.

The study consists of a placebo-controlled period to study week 54, followed by a long-term extension to study week 518. The placebo-controlled period is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel, 2 additional treatment arms beginning in parallel, and the last 2 treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period for up to 42 additional doses of active drug for the first 3 years of LTE. Furthermore, up until the last participant in Arms 8 and 9 has had his or her last dose in the fifth year of the LTE, eligible participants will be able to continue treatment beyond the third year of the LTE.

NCT01677572
Patrocinador PrincipalBiogen
Última actualización: 3 de agosto de 2020
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 197 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 50 a 90 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos MentalesEnfermedades del CerebroEnfermedades del Sistema Nervioso CentralDemenciaEnfermedades del sistema nerviosoEnfermedad de Alzheimer

Criterios

Key Inclusion Criteria: Participants must be ambulatory. Participants must meet the following core clinical criteria as determined by the Investigator: Prodromal Alzheimer's Disease (AD) (all of the criteria must apply): Mini Mental State Examination (MMSE) scores between 24-30 (inclusive) a spontaneous memory complaint objective memory loss defined as a free recall score of ≤27 on the Free and Cued Selective Reminding Test (FCSRT) a global Clinical Dementia Rating Scale (CDR) score of 0.5 absence of significant levels of impairment in other cognitive domains essentially preserved activities of daily living, and an absence of dementia. OR Mild Alzheimer's Disease (AD) criteria (all criteria must apply): Mini Mental State Examination (MMSE) scores between 20-26 (inclusive) a global Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0 meeting the National Institute on Aging-Alzheimer's Association core clinical criteria for probable AD. Participants must have a positive florbetapir positron emission tomography (PET) amyloid scan. Participants must consent to apolipoprotein E (ApoE) genotyping. Apart from clinical diagnosis of Alzheimer's Disease (AD), participant must be in good health. Must have a reliable informant or caregiver. Key Exclusion Criteria: Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment. Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year. Clinically significant psychiatric illness in past 6 months. Seizure in the past 3 years. Poorly controlled diabetes mellitus. History of unstable angina, myocardial infarction, chronic heart failure, or clinical significant conduction abnormalities within 1 year prior to Screening. Indication of impaired renal or liver function. Have human immunodeficiency virus (HIV) infection. Have a significant systematic illness or infection in past 30 days. Brain MRI showing evidence of acute or sub-acute micro or macrohemorrhage, greater than 4 microhemorrhages, cortical infarct or greater than one 1 lunar infarct. Any contraindications to brain MRI or positron emission tomography (PET) scans. Negative positron emission tomography (PET) scan with any amyloid-targeting ligand within 48 weeks of Screening. Clinically significant 12-lead electrocardiogram (ECG) abnormalities. Alcohol or substance abuse in past 1 year. Taking blood thinners (except for aspirin at a prophylactic dose or less) Have changes in medications or doses of medication in past 4 weeks. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

9 grupos de intervención están designados en este estudio

44.44444444444444% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Intravenous doses of low-dose level #1 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.

Grupo II

Experimental
Intravenous doses of low-dose level #2 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.

Grupo III

Placebo
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.

Grupo IV

Experimental
Intravenous doses of mid-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.

Grupo 5

Placebo
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.

Grupo 6

Experimental
Intravenous doses of high-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.

Grupo 7

Placebo
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.

Grupo 8

Experimental
Intravenous doses of Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.

Grupo 9

Placebo
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 32 ubicaciones

NNS Clinical Research, LLC

Tucson, United StatesAbrir NNS Clinical Research, LLC en Google Maps

Senior Clinical Trials, Inc.

Laguna Hills, United States

Torrance Clinical Research Institute, Inc.

Lomita, United States

Collaborative Neuroscience Network, LLC

Long Beach, United States
Suspendido32 Centros de Estudio