FDA Deals Major Blow to Patients with Alzheimer’s-Related Psychosis

“The FDA is telling Alzheimer’s patients to wait and hope, but we can’t wait.” -- Vradenburg

Washington, D.C. [August 5, 2022] – Yesterday, Acadia Pharmaceuticals announced that it has been told by the FDA it must conduct even more clinical trials before the agency will consider approving the use of a drug to treat some of the most frightening, most bothersome symptoms of Alzheimer’s disease: hallucinations and delusions. The drug, pimavanserin, was approved in 2016 to treat those symptoms in Parkinson’s disease. There are currently no drugs approved to treat hallucinations and delusions in Alzheimer’s.

“With this decision, the FDA is telling Alzheimer’s patients to wait and hope, but we can’t wait,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “It’s hard to imagine the fear and suffering patients and their loved ones feel when someone with Alzheimer’s experiences severe hallucinations or delusions and there are no treatments approved. FDA needs to work urgently with Acadia to determine the minimum additional data needed to determine whether the drug is safe and effective. 

“On the heels of Medicare’s denial of coverage of the only disease-modifying drug on the market, this is just more disappointing news.”

Hallucinations and delusions are among the most significant contributors to the wrenching decision some families make that they cannot take care of their loved one at home. As part of the public comment portion of an FDA advisory committee meeting in June, UsAgainstAlzheimer’s board member Meryl Comer shared her firsthand experience caring for someone living with Alzheimer’s-related psychosis. Read her prepared remarks here.

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UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.