In a somewhat surprising move, the US Food and Drug Administration (FDA) has declined to grant accelerated approval to Eli Lilly’s donanemab Read the full press release from Eli Lilly here Like aducanumab and lecanemab, which were previously granted accelerated approval by the FDA, donanemab is a monoclonal antibody treatment against the beta amyloid protein that accumulates in the brain of a person with Alzheimer’s disease. Eli Lilly published very promising results for donanemab in 2021, which included demonstration that donanemab could lower amyloid levels in the brain of people with mild cognitive impairment and mild dementia (the basis for…

January 6, 2023 – Today, as expected, the US Food and Drug Administration granted accelerated approval to lecanemab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. Lecanemab was approved on the basis of the treatment’s demonstrated effect of lowering levels of brain amyloid, as measured by a type of brain scan known as positron emission tomography (PET) imaging. Lecanemab is now approved for the treatment of patients with mild cognitive impairment or mild dementia, and should be used in patients in whom that same amyloid PET brain scan (or measures…

Elizabeth Head, PhD UCI MIND Faculty Member Elizabeth Head, PhD was featured in the Akron Beacon Journal: I recently interviewed Dr. Elizabeth Head, a neuropathology core co-investigator at the Alzheimer's Disease Research Center at University of California, Irvine. While she collaborates with researchers studying Alzheimer's in the general population, her research is focused specifically on the Down syndrome population. Her team and others are conducting longitudinal studies, in which volunteers with Down syndrome participate for many years, discovering relevant data that are the building blocks for future treatments. Read the full article here >

Bells and Whistles. ACI-35.030 includes a phospho-tau peptide anchored to a liposomal bilayer, along with two adjuvants and a non-target T cell epitope to rally B cells to churn out antibodies against phospho-tau. The work of our faculty, researchers, and collaborators was highlighted in a recent Alzforum article on anti-tau vaccines. AC Immune updates Phase 1b/2 comparison of two anti-#tau vaccines. A liposomal vaccine prompted #antibody response against phospho-tau. Preclinical data bode well for another tau vaccine; first trial slated for next year. Read more >

UCI MIND Director Joshua Grill, PhD is featured in and comments on Alzforum's report on "convincing and noteworthy" lecanemab results. The slightly larger effect on ADLs caught the interest of some scientists, since these can feel most important to participants. “ indicates that patients and families could benefit from slowing of observable functional worsening,” Joshua Grill of the University of California, Irvine, wrote to Alzforum (full comments below). Read his commentary here > Read the full article here > Diverging Trajectories. People on lecanemab worsened more slowly on the CDR-SB than did people on placebo, resulting in a quarter less progression…