Washington, D.C. (April 5, 2021) - UsAgainstAlzheimer’s issued the following statement by George Vradenburg, chairman and co-founder, on the Food and Drug Administration’s (FDA) failure to approve Acadia’s drug pimavanserin as a treatment for dementia-related hallucinations and delusions.  

“We are extremely frustrated and disappointed that the FDA has failed to approve pimavanserin, which would have been the first therapy to treat dementia-related hallucinations and delusions. This drug was found to be safe and effective in a Phase 3 clinical trial whose study design was approved by the FDA.  And this drug was approved as safe and effective — and has been used for years — in people experiencing Parkinson’s-related psychosis.

“UsAgainstAlzheimer’s urges Acadia and the FDA to meet as soon as possible to find a path forward for this drug’s expeditious approval.

“Patients and their families desperately need help with these symptoms. About 8 million Americans are living with dementia, and dementia-related hallucinations and delusions affect the quality of life and health of about 2.4 million of them. These delusions and hallucinations take a severe emotional, financial and social toll – especially on caregivers who are challenged to deal with a loved one whose symptoms prevent them from understanding their reality. Dementia-related psychosis is one of the most frequent causes for families’ decisions to place their loved ones in institutional care settings, with the additional consequences of family separation and financial burden. 

“There are no other good options for treatment of dementia-related psychosis. Anti-psychotic drugs now being used as treatments for these delusions and hallucinations have limited effectiveness and severe side effects – including higher rates of death. The unmet need felt by patients and caregivers led to high hopes that this treatment would soon be available, but the FDA’s refusal to approve this treatment means they must wait even longer for a treatment.” 

The UsAgainstAlzheimer’s A-LIST®, Acadia and the Lewy Body Dementia Association jointly conducted a qualitative and quantitative study of people who have a diagnosis of dementia with psychotic symptoms or their care partners. The survey results show that many patients with dementia-related psychosis – who have symptoms such as visual hallucinations, auditory hallucinations, and persecutory delusions – are unaware of what’s happening or how to communicate what they are experiencing. This increases stress and anxiety and affects the daily lives of both patients and their caregivers. Two research posters reporting on this dementia-related psychosis research (links here and here) were presented at the 2020 AAIC conference.  

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About UsAgainstAlzheimer’s

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.