NCT05399888

A Study to Learn About the Safety of 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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease Dementia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, researchers will learn more about a study drug called 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 BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 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 BIIB080. 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 BIIB080, 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 BIIB080, 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 BIIB080 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 BIIB080 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.

Detailed description

BIIB080 is an investigational antisense therapy designed to target microtubule-associated protein tau (MAPT) messenger ribonucleic acid (mRNA) and prevent production of tau protein.

Conditions

• Mild Cognitive Impairment Due to Alzheimer's Disease
• Alzheimer's Disease Dementia

Interventions

Type	Name	Description
DRUG	BIIB080	Administered as specified in the treatment arm.
DRUG	BIIB080-matching placebo	Administered as specified in the treatment arm.

Timeline

• Start date: 2022-08-24
• Primary completion: 2026-05-14
• Completion: 2029-01-08
• First posted: 2022-06-01
• Last updated: 2025-05-18

Locations

138 sites across 17 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study