The U.S. Food and Drug Administration has named Eli Lilly’s donanemab a breakthrough therapy for treating Alzheimer’s disease, the company announced in a press release. Lilly said it intends to submit a biologics license application or BLA — which would allow it to market donanemab in the U.S.
Based on new evidence from an ongoing Phase 2b clinical trial, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to lecanemab, also called BAN2401, an investigational antibody for treating early Alzheimer’s disease. The therapy, being developed jointly by Eisai and Biogen, is designed to…
The investigational therapy gantenerumab significantly lowered levels of established biomarkers in a rare, inherited form of early-onset Alzheimer’s disease, despite failing to slow cognitive decline or memory loss in symptomatic and asymptomatic patients, according to data from a Phase 2/3 clinical trial. Based on these results, enrolled patients…
Aduhelm (aducanumab), approved for Alzheimer’s disease in the U.S., is most appropriate for people with mild cognitive impairment (MCI) due to the disease or early Alzheimer’s dementia, the disorders for which it was tested in clinical trials and subsequently approved, according to experts from the scientific community. The experts…
Cholinesterase inhibitors, a class of medicines used for treating Alzheimer’s disease, are linked to long-term reductions in cognitive decline and in the risk of death among patients, a recent study found. In fact, the cognitive benefits and reduced mortality lasted for up to five years after diagnosis, the researchers…
Gosuranemab, an investigational antibody against the tau protein, failed to meet its primary and exploratory efficacy goals in the TANGO Phase 2 study, its developer, Biogen, has announced. Now, the TANGO trial has been terminated and Biogen will cease the clinical development of gosuranemab as a potential therapy for…
Activation of the sigma-1 receptor or SIGMAR1 — whose production is typically increased with age, but reduced in people with Alzheimer’s disease — drives a series of neuroprotective effects, including the clearance of unnecessary or damaged cellular components, a review study highlights. This supports the therapeutic potential of…
A new treatment for people with Alzheimer’s disease — the first approved by the U.S. Food and Drug Administration (FDA) in nearly 20 years — will be available soon in the U.S. But the reception being given to Aduhelm (aducanumab) is mixed. Some patients…
A first patient has been dosed in APOLLOE4, a Phase 3 trial testing the efficacy and safety of ALZ-801, an investigational oral treatment by Alzheon for people carrying a specific genetic variant linked to early onset, rapidly progressive Alzheimer’s disease. ALZ-801 is a small molecule designed to prevent…
The National Institute on Aging (NIA) has awarded a five-year grant worth up to $5 million to support a clinical trial that will test AAV2-BDNF, an investigational gene therapy, in people with Alzheimer’s disease or mild cognitive impairment, which often precedes dementia. The therapy aims to deliver the gene BDNF to…
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