2.2 Dementia-Related Psychosis

Pimavanserin – Dementia-Related Psychosis


Pimavanserin is a proprietary small molecule that we have advanced to Phase 3 development for dementia-related psychosis. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that are thought to play an important role in dementia-related psychosis.

About Dementia-Related Psychosis

Around 8 million people in the United States are living with dementia and approximately half are diagnosed with the disease. Studies suggest that approximately 30% of patients with dementia have psychosis, commonly consisting of hallucinations and delusions. Dementia-related psychosis is a serious medical condition for which there is currently no FDA-approved therapy.

Dementia related psychosis includes psychosis in:
–  Alzheimer’s disease
–  Dementia with Lewy bodies
–  Parkinson’s disease dementia
–  Vascular dementia
–  Frontotemporal dementia

Serious consequences have been associated with severe or persistent psychosis in patients with dementia such as repeated hospital admissions, earlier progression to nursing home care, more rapid progression of dementia, and increased risk of morbidity and mortality.


We are currently conducting a Phase 3, randomized, double-blind, placebo-controlled study, referred to as HARMONY, evaluating the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The objective of the study is to evaluate the ability of pimavanserin to prevent relapse of psychotic symptoms in a broad population of patients with the most common subtypes of dementia.

The FDA has granted Breakthrough Therapy Designation to pimavanserin for dementia-related psychosis.