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Study identifier: NCT05399888 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

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

Condition: Mild Cognitive Impairment Due to Alzheimer's Disease · Alzheimer's Disease Dementia  ·  Sponsor: Biogen

PhasePhase 2
Planned participants416
Who can joinAll sexes, 50 Years to 80 Years
Healthy volunteersNo

About this study

In 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 trea…

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (138)

Xenoscience Inc.Phoenix, Arizona, United States
HonorHealth NeurologyScottsdale, Arizona, United States
Banner Sun Health Research InstituteSun City, Arizona, United States
Center for NeurosciencesTucson, Arizona, United States
Mary S. Easton Center for Alzheimer's Disease Research, UCLALos Angeles, California, United States
PNS Clinical Research, LLC dbaOrange, California, United States
Stanford Hospital and ClinicsPalo Alto, California, United States
Sutter Institute for Medical ResearchSacramento, California, United States
University of California San Diego Medical CenterSan Diego, California, United States
University of California San Francisco (PARENT)San Francisco, California, United States
Rocky Mountain Movement Disorders Center, PCEnglewood, Colorado, United States
Charter Research, LLCLady Lake, Florida, United States

+ 126 more locations — full list on the registry record.

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