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FDA Rejects Nuplazid to Treat Dementia-related Psychosis

The U.S. Food and Drug Administration (FDA) has rejected Acadia Pharmaceuticals’ request that Nuplazid (pimavanserin) be the first approved treatment of hallucinations and delusions associated with dementia-related psychosis. The decision comes less than nine months since the agency agreed to review the company’s supplemental new drug application, and a month…

Sargramostim, Immune System Activator, May Aid Cognition, Small Trial Finds

People with mild-to-moderate Alzheimer’s disease  treated for three weeks with sargramostim, a medication that activates the immune system, showed improvements in cognition in a small clinical trial. These results support further investigation of sargramostim — and, more generally, the strategy of targeted immune activation — in treating Alzheimer’s, its…

Donanemab Shows Potential for Early Alzheimer’s in Phase 2 Trial

Donanemab showed an ability to slow cognitive decline and the loss of daily life abilities in people at earlier stages of Alzheimer’s disease relative to those given a placebo in the Phase 2 TRAILBLAZER-ALZ trial, researchers report. A plaque-targeting therapy, donanemab also cleared substantial amounts of amyloid plaques in the brains…

Neurostimulation Slows Decline in Mild-to-moderate Alzheimer’s, Trial Finds

Non-invasive neurostimulation given to people with mild-to-moderate Alzheimer’s disease significantly and safely slowed their rate of functional and cognitive decline, meeting key goals of the Phase 2 OVERTURE study, according to data presented at the 2021 AD/PD Conference. Its neurostimulation device, being referred to as a digital therapeutic, uses gamma frequency…

FDA Finds ‘Deficiencies’ in Request for Nuplazid to Treat Dementia-Related Psychosis

The U.S. Food and Drug Administration (FDA) found “deficiencies” that preclude discussing further steps in the approval process for Nuplazid (pimavanserin) as a possible treatment of dementia-related psychosis, according to a press release from Acadia Pharmaceuticals, Nuplazid’s maker. Discussions on “labeling and post-marketing requirements/commitments” cannot take place before certain…