Abstract Details

Title Pimavanserin treatment of hallucinations and delusions in patients with Parkinson’s disease dementia: post hoc analysis of the HARMONY trial

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 006

Objective Describe the efficacy and safety of pimavanserin 34 mg for the treatment of hallucinations and delusions in a subgroup of patients with Parkinson’s Disease dementia (PDD) in HARMONY.

Background Pimavanserin 34 mg is approved in the US to treat hallucinations and delusions associated with Parkinson’s Disease psychosis (PDP) and was investigated for the treatment of dementia-related psychosis (DRP), including PDD patients, in HARMONY.

Design/Methods HARMONY (NCT03325556) was a Phase 3, placebo-controlled, randomized discontinuation study. Eligible patients received pimavanserin for 12 weeks during the open-label (OL) period (N=392). Patients with sustained response at weeks 8 and 12 were randomized 1:1 to continue pimavanserin or receive placebo for up to 26 weeks in the double-blind (DB) period. The primary endpoint was time from randomization to psychosis relapse. The Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) and Mini-Mental State Examination (MMSE) were used to evaluate motor function and cognition.

Results 59 enrollees had PDD and initiated pimavanserin 34 mg, 49/59 continued to receive pimavanserin 34 mg. In the OL period, most PDD patients (73.5% [36/49]) exhibited a sustained response and were randomized to pimavanserin (n=16) or placebo (n=20). The risk of psychosis relapse was lower with pimavanserin than placebo (hazard ratio: 0.052; 95% CI: 0.016, 0.166; 1-sided P<0.0001). 1 pimavanserin-treated and 9 placebo-treated patients met relapse criteria. In the OL period, 46.9% (n=23) of patients experienced any treatment-emergent adverse event (TEAE). During the DB period, TEAE rates were balanced (pimavanserin, 31.3% [n=5], placebo, 45.0% [n=9]). There was no negative effect of pimavanserin on ESRS-A or MMSE scores over the duration of the study.

Conclusions Pimavanserin 34 mg reduced the risk of psychosis relapse in PDD patients. Pimavanserin was well tolerated, with no negative effect on motor or cognitive function. These data show the maintenance of antipsychotic efficacy and safety of pimavanserin in PDD patients.

Authors/Disclosures
Daniel Weintraub PRESENTER	Daniel Weintraub has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clintrex. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Daniel Weintraub has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Modality.ai. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CuraSen. Daniel Weintraub has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Takeda. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boehringer Ingelheim. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Daniel Weintraub has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorder Society. The institution of Daniel Weintraub has received research support from NIH. The institution of Daniel Weintraub has received research support from Fox Foundation. The institution of Daniel Weintraub has received research support from IPMDS. Daniel Weintraub has received intellectual property interests from a discovery or technology relating to health care.
Alberto J. Espay, MD, FAAN (University of Cincinnati)	Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Tanabe Pharma America (formerly, Neuroderm). Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NeuroDiagnostics, Inc (SYNAPS Dx). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Intrance Medical Systems, Inc.. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis Precision Medicines. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Citrus Health. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Vibhash D. Sharma, MD, FAAN (University of Texas Southwestern Medical Center)	Dr. Sharma has nothing to disclose.
Pierre Tariot (Banner Alzheimer's Institute)	Pierre Tariot has received personal compensation for serving as an employee of Banner Alzheimer's Institute. Pierre Tariot has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Pierre Tariot has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AC Immune. Pierre Tariot has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Pierre Tariot has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for WebMD. Pierre Tariot has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arcadia. Pierre Tariot has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Pierre Tariot has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BioXcel. Pierre Tariot has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cortexyme. Pierre Tariot has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Pierre Tariot has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for eNOVA. Pierre Tariot has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Pierre Tariot has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Syneos. Pierre Tariot has received intellectual property interests from a discovery or technology relating to health care.
Victor Abler, DO (Acadia Pharmaceuticals)	Dr. Abler has stock in Acadia Pharmaceuticals .
Sanjeev Pathak, MD (Acadia Pharmaceuticals)	Dr. Pathak has received personal compensation for serving as an employee of Acadia Pharmaceuticals.
	No disclosure on file

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