Margarida Maia, PhD, science writer —

Seelos Therapeutics is gearing up for a pilot study, in Australia, testing SLS-005 (trehalose) — its investigational therapy for people with Alzheimer’s disease — after receiving an acknowledgment letter from the country’s regulatory body for clinical trials. The letter, from the Australian Government Department of Health Therapeutic Goods…

A first patient has joined the Tau NexGen study that will test two antibodies in combination — targeting both amyloid and tau proteins — as a potential treatment for early-onset Alzheimer’s disease caused by genetic mutations, according to a press release. Tau NexGen is a newly added arm…

Cassava Sciences has launched a new website, called Rethink-ALZ.com, to make it easier for anyone interested to access information about two Phase 3 clinical studies of simufilam, the company’s oral investigational therapy for mild-to-moderate Alzheimer’s disease. The trials, dubbed RETHINK-ALZ and REFOCUS-ALZ, are ongoing in the U.S. and Canada,…

Lecanemab, an investigational antibody also known as BAN2401, has been granted a fast track designation from the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. The antibody, developed jointly by Biogen and Eisai, is…

Biogen and Eisai are stepping up their Phase 4 post-marketing confirmatory study to verify that Aduhelm (aducanumab) is meeting the expected clinical benefit in patients with early-stage Alzheimer’s disease. The companies plan to submit the study’s final protocol for review to the U.S. Food and Drug Administration…

Altoida is starting a five-year study to feed its app-based Precision Neurology device with data from thousands of patients across all stages of Alzheimer’s, to help validate the device’s ability to diagnose the disease at the earliest phases. The device will use artificial intelligence (AI) to collect…

AlzeCure Pharma has been granted approval by Swedish regulatory authorities to start its third Phase 1 study of ACD856, the company’s leading therapeutic candidate for Alzheimer’s disease. The study is designed to test multiple ascending doses of the medication, which means that the amount of ACD856 will be…

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…

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…

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…