Lindsey Shapiro, PhD, science writer —

A U.S. Food and Drug Administration (FDA) advisory committee has decided that data from the Phase 3 Clarity AD trial are sufficient to confirm the clinical benefits of Leqembi (lecanemab) for the treatment of early Alzheimer’s disease. The FDA now will consider the unanimous opinion of the committee…

One year of treatment with ALZ-801 (valiltramiprosate) was found in a Phase 2 trial to improve cognition and lower the levels of disease biomarkers among people with early Alzheimer’s with one or two copies of the apolipoprotein E4 (APOE4) disease-associated genetic variant. Importantly, the investigational therapy from…

The Phase 1 INTERCEPT-AD trial testing the investigational antibody ACU193 in patients with early Alzheimer’s disease has now completed enrollment, according to its developer, Acumen Pharmaceuticals. Top-line results, including safety and proof-of-concept mechanism data, are expected ahead of schedule in the third quarter of this year. “Today’s…

A low dose of ACI-24.060, AC Immune’s investigational vaccine therapy, safely elicited the production of anti-amyloid beta antibodies among patients with Alzheimer’s disease, according to an interim analysis of a Phase 1b/2 trial. The study, called ABATE (NCT05462106), is evaluating the vaccine’s safety and ability to provoke…

The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s application for the accelerated approval of its amyloid-clearing antibody donanemab for treating Alzheimer’s disease. An accelerated approval lets the FDA grant conditional marketing authorization for a treatment based on preliminary safety and efficacy data, but additional clinical…

Note: This story was updated Feb. 7, 2023, to correct the number of participants in the Study 201 (NCT01767311), which evaluated Leqembi in 856 people with early Alzheimer’s. Lecanemab (BAN2401), Eisai and Biogen’s amyloid-targeted antibody therapy, has earned approval — under an accelerated approval pathway — from the U.S.

The U.S. Food and Drug Administration (FDA) has cleared for use tests designed by Roche to measure the levels of two Alzheimer’s disease biomarkers — beta-amyloid and phosphorylated tau — in cerebrospinal fluid (CSF), the fluid surrounding the brain and spinal cord. Roche reported that these assays, which will…

Intranasal, or into-the-nose, delivery of foralumab, an investigational antibody-based treatment being developed by Tiziana Life Sciences, restored the activity of microglial cells and improved cognition in a mouse model of Alzheimer’s disease. Formerly known as NI-0401, foralumab acts to lower inflammation by blocking the activity of CD3, a protein…

Buntanetap, an experimental treatment for neurodegenerative diseases, was safe, lowered toxic protein accumulation, reduced inflammation, and improved cognition in people with Alzheimer’s disease. This was according to data from a Phase 2a trial (NCT04524351) that evaluated the investigational therapy against a placebo…

Treatment with Alzheon‘s oral candidate ALZ-801 (valiltramiprosate) lowered levels of a key biomarker for Alzheimer’s disease — and led to significant memory improvements in people with the neurodegenerative disorder. That’s according to data from a six-month interim analysis of an ongoing Phase 2 biomarker…