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BIIB092 · TANGO

Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

Ensayo de BIOGEN INC. en Enfermedad de Alzheimer.

Más ensayos de: Enfermedad de Alzheimer.

Fase

Fase 2

Estado

Interrumpido

Participantes

654

previstos

Centros

101

Fin del objetivo primario

ago 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2018.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.».

Qué mide

PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD. The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03352557), actualizada en oct 2022.