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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
NCT05399888 · View on ClinicalTrials.gov ↗
Study 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 sc
Conditions Studied
Interventions
- DRUG BIIB080
- DRUG BIIB080-matching placebo
Study Locations (20)
California
- Mary S. Easton Center for Alzheimer's Disease Research, UCLA — Los Angeles
- PNS Clinical Research, LLC dba — Orange
- Stanford Hospital and Clinics — Palo Alto
- Sutter Institute for Medical Research — Sacramento
- University of California San Diego Medical Center — San Diego
- University of California San Francisco (PARENT) — San Francisco
Florida
- Charter Research, LLC — Lady Lake
- K2 Medical Research, LLC — Orlando
- Advent Health — Orlando
- Conquest Research — Winter Park
- Charter Research, LLC — Winter Park
Arizona
- Xenoscience Inc. — Phoenix
- HonorHealth Neurology — Scottsdale
- Banner Sun Health Research Institute — Sun City
- Center for Neurosciences — Tucson
Massachusetts
- Brigham and Women's Hospital Department of Neurology — Boston
- Beth Israel Deaconess Medical Center — Boston
- Lahey Clinic Medical Center - Burlington — Burlington
Colorado
- Rocky Mountain Movement Disorders Center, PC — Englewood
Hawaii
- Hawaii Pacific Neuroscience — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2022-08-24 |
| Est. Completion | 2029-01-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05399888
The ClinicalTrials.gov registry entry for NCT05399888 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Mild Cognitive Impairment Due to Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions — of which BIIB080 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05399888 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05399888 about?
NCT05399888 is a clinical study titled "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". 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 focu...
What is the current status of trial NCT05399888?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 416 participants. The study started on 2022-08-24. Estimated completion is 2029-01-08.
What conditions does trial NCT05399888 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment Due to Alzheimer's Disease, Alzheimer's Disease Dementia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05399888?
The interventions under investigation include: BIIB080 (DRUG), BIIB080-matching placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05399888?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05399888 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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