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Diranersen · CELIA

A Study to Learn About the Safety of Diranersen (BIIB080) Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

Ensayo de BIOGEN INC. en Mild Cognitive Impairment Due to Alzheimer's Disease · Alzheimer's Disease Dementia (del registro, en inglés).

Fase

Fase 2

Estado

En marcha, sin reclutar

Participantes

416

previstos

Centros

138

Fin del objetivo primario

mar 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ago 2022.

Qué mide

Dose response in Change From Baseline to Week 76 on the CDR-SB (del registro, en inglés) (del inicio a la semana 76)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn this study, researchers will learn more about a study drug called diranersen (BIIB080). The study will focus on participants with mild cognitive impairment or mild dementia due to AD. The main question researchers are trying to answer is if diranersen can slow the worsening of AD more than placebo. It will focus on what dose of diranersen slows worsening of AD the most. To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB. * Clinicians use the CDR-SB to measure several categories of dementia symptoms. * The results for each category are added together for a total score. Lower scores are better. Researchers will also learn more about the safety of diranersen. The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension (LTE) Period. The 2nd part of the study will help researchers learn about the long-term safety of diranersen, and how it affects the participant's daily life, thinking, and memory abilities in the longer term. A description of how the study will be done is given below. * After screening, participants will first receive either a low dose or high dose of diranersen, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine. * Participants will receive diranersen or placebo once every 12 weeks or 24 weeks. * After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks. * In the extension period, participants who received placebo will be switched to high dose diranersen every 12 or 24 weeks. * Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods. * Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period. * After the screening period, most participants will visit the clinic every 6 weeks.

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Ficha completa en ClinicalTrials.gov (NCT05399888), actualizada en jun 2026.