News

New Study Will Test Cannabinoid-based Therapy for Agitation

SciSparc is set to start a Phase 2a study evaluating the safety and efficacy of SCI-110, its investigational cannabinoid-based therapy for Alzheimer’s disease and agitation. “We are very excited to begin our trial,” Adi Zuloff-Shani, PhD, chief technologies officer of SciSparc, said in a press release, noting…

Alzamend Seeks to to Test AL001 as Dementia Therapy

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,…

Lilly’s Donanemab Granted FDA Breakthrough Therapy Status

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.

With New Trial Data, Lecanemab Wins FDA Breakthrough Status

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…

Gantenerumab Lowers Key Protein Levels in Early-onset Disease Trial

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 Most Appropriate for Early-stage Alzheimer’s, Experts Say

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…