Patricia Inacio, PhD, science writer —

The U.S. Food and Drug Administration (FDA) has kept to its initial decision to reject a request by Acadia Pharmaceuticals to expand Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease-related psychosis. In a complete response letter (CRL) indicating it had finished its review of the…

A large clinical trial has received $45 million in U.S. funding to evaluate the efficacy of benfotiamine — a lab-made precursor of thiamine or vitamin B1 — in slowing the cognitive decline of those with mild Alzheimer’s disease or mild cognitive impairment. The five-year grant was awarded by the…

ALPHA-1062, Alpha Cognition’s investigational oral tablet for mild to moderate Alzheimer’s disease, may be a bioequivalent substitute for the approved therapy Razadyne, according to a pivotal trial with healthy volunteers. The pro-drug therapy — meaning that the medication is metabolized in the body, after administration — showed positive…

Early treatment with crenezumab, an investigational anti-amyloid antibody, failed to significantly slow or prevent cognitive decline in a group of people with a genetic risk for early-onset Alzheimer’s disease, data from a Phase 2 trial show. Numerical differences favoring crenezumab over a placebo were seen across…

A Phase 2 clinical trial will test BMND08, an investigational oral therapy based on a natural psychedelic, in treating depression and anxiety in people with Alzheimer’s disease, its developer, Biomind Labs, reported. The company’s announcement follows the trial’s approval by an institutional review board in Argentina.

Alzamend Neuro has dosed the first patient in the multiple ascending dose portion of its Phase 2a clinical trial of AL001, an investigational oral therapy for dementia related to Alzheimer’s disease. This multiple ascending dose (MAD) part follows positive results from a Phase 1 trial. Topline data…

Eisai has completed a rolling submission to the U.S. Food and Drug Administration (FDA) to seek approval for lecanemab (BAN2401), an investigational antibody for the treatment of early Alzheimer’s disease accompanied by beta-amyloid deposits in the brain. The request — made in the form of a biologics…

A U.S. Food and Drug Administration (FDA) advisory committee will host a virtual meeting to review a request to expand the approval of Nuplazid (pimavanserin) to include psychosis due to Alzheimer’s disease dementia. The FDA’s Psychopharmacologic Drugs Advisory committee meeting on the application recently submitted by Acadia Pharmaceuticals, which developed…

A Miami Veterans Affairs (VA) clinical site is now part of Longeveron’s Phase 2a clinical trial testing Lomecel-B — an investigational, bone marrow-derived, medicinal signaling cell (MSC) treatment — in patients with mild Alzheimer’s disease. The new clinical site was added following a Cooperative…

A first patient has been dosed in a Phase 2 trial of XPro1595, INmune Bio’s candidate therapy for Alzheimer’s disease. The MINDFuL trial (NCT05318976) aims to recruit around 201 people, ages 60–85, with mild Alzheimer’s and biomarkers of brain inflammation across multiple sites…