Patricia Inacio, PhD, science writer —

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…

Gain Therapeutics‘ investigational STAR (small-molecule structurally targeted allosteric regulators) candidate lowered toxic amyloid-beta and tau protein levels, both hallmarks of Alzheimer’s disease, in a cellular model of the disease. Treatment with the STAR molecule enhanced the survival and boosted communication between nerve cells, the company announced. The…

Alzamend Neuro’s experimental oral therapy for dementia related to Alzheimer’s disease may deliver the benefits of marketed lithium-based treatments but with fewer side effects, data from a completed Phase 1 trial show. A 150 milligrams (mg) dose of the therapy, called AL001, led to similar levels of lithium…

Biogen, the co-developer of Aduhelm (aducanumab) has submitted the final protocol for ENVISION — the Phase 4 post-marketing study of the therapy in early Alzheimer’s disease — to the U.S. Food and Drug Administration (FDA) for review and approval, the company has announced. Screening of the first…

Prothena has begun testing single ascending doses (SAD) of PRX012, its investigational anti-amyloid beta antibody therapy, in a Phase 1 clinical trial with healthy volunteers and people with Alzheimer’s disease. This follows the recent approval of the company’s investigational new drug (IND) application for PRX012 by the U.S.

LX1001, a one-time gene therapy for Alzheimer’s disease being developed by Lexeo Therapeutics, raised levels of the protective APOE2 protein in the cerebrospinal fluid (CSF), early data from an ongoing Phase 1/2 trial shows. Findings in a first patient group treated at low dose also showed the gene therapy reduced the…