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(s) studied
Investigational drug(s) / intervention(s)
Diranersen: Administered as specified in the treatment arm.
Diranersen-matching placebo: Administered as specified in the treatment arm.
Study summary
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 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.
Eligibility
Primary outcome measure(s)
- Dose response in Change From Baseline to Week 76 on the CDR-SB — Baseline to Week 76
The Clinical Dementia Rating (CDR) scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The CDR-SB is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
Trial sites (138)
| Facility | City | Region | Status |
|---|---|---|---|
| Xenoscience Inc. | Phoenix | Arizona | |
| HonorHealth Neurology | Scottsdale | Arizona | |
| Banner Sun Health Research Institute | Sun City | Arizona | |
| Center for Neurosciences | Tucson | Arizona | |
| Mary S. Easton Center for Alzheimer's Disease Research, UCLA | Los Angeles | California | |
| PNS Clinical Research, LLC dba | Orange | California | |
| Stanford Hospital and Clinics | Palo Alto | California | |
| Sutter Institute for Medical Research | Sacramento | California | |
| University of California San Diego Medical Center | San Diego | California | |
| University of California San Francisco (PARENT) | San Francisco | California | |
| Rocky Mountain Movement Disorders Center, PC | Englewood | Colorado | |
| Charter Research, LLC | Lady Lake | Florida | |
| K2 Medical Research, LLC | Orlando | Florida | |
| Advent Health | Orlando | Florida | |
| Conquest Research | Winter Park | Florida | |
| Charter Research, LLC | Winter Park | Florida | |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | |
| Brigham and Women's Hospital Department of Neurology | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Lahey Clinic Medical Center - Burlington | Burlington | Massachusetts | |
| Boston Center for Memory | Newton | Massachusetts | |
| Neurological Associates of Albany, PC | Albany | New York | |
| Dent Neurologic Institute | Amherst | New York | |
| New York University Medical Center PRIME | New York | New York | |
| South Shore Neurologic Associates, P.C. | Patchogue | New York | |
| SUNY Upstate Medical University | Syracuse | New York | |
| Duke University | Durham | North Carolina | |
| AMC Research, LLC | Matthews | North Carolina | |
| NeuroScience Research Center, LLC. | Canton | Ohio | |
| University of Cincinnati Physicians Group, LLC | Cincinnati | Ohio | |
| Butler Hospital | Providence | Rhode Island | |
| Neurology Clinic, PC | Cordova | Tennessee | |
| Neurology Consultants of Dallas, PA | Dallas | Texas | |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | |
| EvergreenHealth | Kirkland | Washington | |
| Kingfisher Cooperative, LLC | Spokane | Washington | |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | |
| Southern Neurology | Kogarah | New South Wales | |
| Liverpool Hospital | Liverpool | New South Wales |
+ 98 more sites — see the full list on the official registry below.
More Biogen trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05399888 on ClinicalTrials.gov ↗ ← All trials in Italy