Trial for Biogen’s Experimental Alzheimer’s Drug Is Now Recruiting
Biogen is recruiting participants for the CELIA Phase 2 trial of an experimental Alzheimer’s drug that targets tau proteins in the brain.
Charter Research is screening participants to participate in a preliminary drug trial for Biogen’s new experimental Alzheimer’s drug, BIIB080. The Phase 2 trial, called CELIA, will investigate whether spinal infusions of the drug are a safe and effective treatment for mild cognitive impairment and early Alzheimer’s disease. The study will take two years.
BIIB080 is the first genetic therapy designed to stop tau tangles — one of the key biomarkers of Alzheimer’s disease.
In order to produce tau protein in the brain, the brain’s neurons need to “photocopy” the manufacturing instructions from our genome. This set of instructions is the messenger RNA. The drug is being tested to see if destroying these instructions will stop tau formation by destroying these instructions.
This approach to treating Alzheimer’s is different from the two existing, disease-modifying Alzheimer’s treatments now on the market, Leqembi and Aduhelm. Unlike Biogen’s new antisense therapy, Leqembi and Aduhelm are anti-amyloids. They work in a similar way to the body’s immune system, generating antibodies to remove harmful proteins — in this case amyloid, another key Alzheimer’s biomarker.
With BIIB080, Biogen is shifting gears, away from amyloid, and drawing on recent research that indicates tau tangles are important drivers of Alzheimer’s progression.
What to expect from the trial screening process
According to Kimberly Scott, a research coordinator at Charter Research, Charter is currently recruiting participants 50 to 80 years of age who have mild cognitive impairment with evidence of amyloid in the brain, or have mild Alzheimer’s. Individuals who previously received anti-amyloid drugs are not eligible.
The screening process takes three visits across nine weeks, involving cognitive questionnaires, blood tests, an MRI, and a PET scan.
What to expect from the CELIA trial
The trial will take about two years to complete, including 1.5 years where participants receive the drug treatment or a placebo via spinal infusion every 12 or 24 weeks.
Participants will visit the trial center every six weeks, with one extra visit at the end of the study to measure Alzheimer’s progression.
Participants are randomly assigned to one of four groups: one will receive a high dose of the drug given every 12 weeks; another will receive a high dose every 24 weeks; yet another will receive a low dose every 24 weeks; and then there’s the placebo group, which will receive a harmless stand-in for the drug every 12 weeks as a control. Participants won’t know which group they’ve been assigned to until the end of the trial.
Ready to learn more?
Kimberly Scott at The Villages site has been enrolling and screening potential trial participants. The principal investigators for the trial are Dr. Jeffrey A. Norton and Dr. Edgardo Rivera. Call one of the two Charter locations to set up screening for trial eligibility:
- The Villages: 352-775-1000
- Winter Park / Orlando: 407-337-1000