Alzamend Neuro has requested approval from the U.S. Food and Drug Administration (FDA) to begin clinical trials to test AL001, its investigational lithium-based ionic cocrystal oral therapy for dementia related to Alzheimer’s disease. The request was made in the form of an investigational new drug (IND) application that,…
The U.S. Food and Drug Administration (FDA) has pulled back the controversial and sweeping approval recently given to Aduhelm (aducanumab), updating the treatment’s label at its manufacturer’s request so that it is prescribed to early-stage Alzheimer’s patients only rather than all with this disease.
The University of Wisconsin School of Medicine and Public Health is recruiting participants for a Phase 3 trial that will test the efficacy and safety of lecanemab (BAN2401) in those who are at risk of developing symptoms of Alzheimer’s disease. The global AHEAD (NCT04468659) study seeks to…
Note: This story was updated July 7, 2021, to reflect that patients with two copies of the APOE4 gene are heterozygous and that the study will measure biomarkers in blood plasma. Patient enrollment is now complete for Alzheon’s Phase 2 clinical trial evaluating the effects of ALZ-801 on disease-related…
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…
Get regular updates to your inbox.