Alzheimer’s anti-amyloid drug Leqembi (generic name lecanemab) was granted accelerated FDA approval last month. But, trials are still ongoing to verify the drug’s benefits to asymptomatic people at risk of developing Alzheimer’s. Presently, K2 Med is enrolling participants for the AHEAD 3-45 trial.
But, trials are still ongoing to verify the drug’s benefits to asymptomatic people at risk of developing Alzheimer’s. Presently, K2 Medical Research is enrolling participants for the AHEAD 3-45 trial.
Drugmakers Biogen and Eisai developed lecanemab to remove toxic beta-amyloid plaques from the brain, which may prevent further damage and progression of Alzheimer’s disease.
Through these trials, eligible participants receive the drug — designed to slow or stop Alzheimer’s progression in people in early stages of the disease — or a placebo, while contributing to important research.
What to expect from the AHEAD 3-45 trial screening process
As of this writing, the AHEAD 3-45 trial is recruiting 1,165 people aged 55 to 80 with high levels of Alzheimer’s blood biomarkers.
In order for candidates aged 55 to 64 to be eligible, they must have at least one of a few additional risk factors: a first-degree relative diagnosed with dementia before age 75; at least one copy of the ApoE4 gene; or a positive amyloid result on a PET scan or lumbar puncture.
In total, the screening process will involve five visits over the course of 90 days.
What to expect from the AHEAD 3-45 trial for Lecanemab
The study will last a total of four years and 22 treatment visits to receive an infusion of the drug. It will also require you to have a study partner who can help you travel to the clinic and answer questions from researchers. Patients will receive $50 for each required study visit that they attend.
In addition to the infusions, participants will also undergo cognitive testing, amyloid PET and tau PET scans at 98 weeks and 216 weeks to measure the changes in cognition and Alzheimer’s pathology.
Since the trial is blinded and placebo-controlled, there is a 50-50 chance participants will receive the drug. If the drug meets its benchmarks in its continued trial and Leqembi receives full FDA approval, everyone in the study will be given the option to continue to receive the drug for free. Whether that will certainly be the case is not yet known.
What to know about anti-amyloid, antibody-based Alzheimer’s treatments like Lecanemab
Today, nearly all existing treatments for Alzheimer’s are designed to help people manage symptoms, like memory loss — but they can’t cure Alzheimer’s, or prevent the disease from progressing. As the prevalence of the disease grows, disease-modifying drugs are a dire need.
Less than two years following the approval of the first anti-amyloid drug Aduhelm, a new anti-amyloid drug by the same drugmakers, called Leqembi, also received accelerated approval. Trial data showed that Leqembi slowed cognitive decline over the course of 18 months.
Eli Lilly’s drug donanemab isn’t far behind, and may be assessed for approval by the end of 2023.
Leqembi is currently priced at $26,500 but the trial provides the opportunity to receive it for free. The AHEAD 3-45 will help scientists understand the effectiveness of the drug, while potentially strengthening the link between amyloid clearance and cognitive improvement.
Ready to learn more?
Stacie Hoeckendorf at the K2 facility has been enrolling and screening potential trial participants. The principal investigator for the trial is Dr. Brandon Lenox. Call K2 Med if you’re interested in participating: 407-500-K2K2 (5252).