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Harmony: Demographic and baseline characteristics from the 12‐week, open‐label treatment phase
Author(s) -
Foff Erin P.,
McEvoy Bradley,
ErtenLyons Deniz,
Sultzer David L.,
Stankovic Srdjan
Publication year - 2020
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.045205
Subject(s) - dementia , dementia with lewy bodies , psychosis , vascular dementia , antipsychotic , medicine , placebo , population , extrapyramidal symptoms , frontotemporal dementia , psychology , psychiatry , disease , schizophrenia (object oriented programming) , pathology , alternative medicine , environmental health
Background Approximately 2.4 million patients in the U.S. experience delusions and hallucinations associated with dementia‐related psychosis (DRP) with no approved therapies. Pimavanserin is a 5HT2A inverse agonist/antagonist approved in the U.S. for treating hallucinations and delusions associated with Parkinson’s disease psychosis. The objective is to examine baseline characteristics from patients with DRP enrolled in the HARMONY study, a pivotal Phase 3, placebo‐controlled, randomized withdrawal study. Method Eligible patients with dementia due to Alzheimer’s disease (AD), Parkinson’s disease dementia (PDD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD) or vascular dementia (VaD) with moderate to severe psychosis (SAPS H+D total score ≥10 AND a CGI‐S score ≥4 AND a SAPS H+D global item (H7 or D13) score ≥4) were enrolled into the 12‐week open‐label (OL) period where they received pimavanserin 34 mg once daily. Patients with sustained response to pimavanserin during the OL were randomized into the double‐blind portion of the trial where they received pimavanserin or placebo and were assessed for relapse of psychosis. Demographic and baseline characteristics of the population were summarized. Result Of 392 patients enrolled, 66.3% of patients had a most likely clinical diagnosis of AD,15.1% PDD, 9.7% VaD, 7.1% DLB, and 1.8% FTD. A non‐specific dementia diagnosis had been given in the past to 110/390 (28.2%) subjects, and 46.9% had previously used an off‐label antipsychotic for DRP. Most patients had moderate dementia (70.2%), and the mean (SE) duration of cognitive impairment was 4.3 (0.1) years. The population was expectedly frail: at baseline, mean age was 74.5 (0.4) years, 46.4% of patients were taking > 5 concomitant medications, and 70.4% had at least 3 comorbid medical conditions. At baseline, mean (SE) scores for SAPS‐H+D, SAPS‐H, SAPS‐D, and CGI‐S were 24.4 (0.47), 14.2 (0.32), 10.2 (0.33), and 4.7 (0.03), respectively; mean (SE) MMSE score was 16.7 (0.24), and 84% had delusions and 79% visual hallucinations. Baseline and disease characteristics by clinical subtype will be summarized. Conclusion Baseline characteristics in the open‐label phase of HARMONY indicate target enrollment of patients with the most common neurodegenerative dementias and moderate to severe psychosis consisting mostly of elderly patients with multiple co‐morbidities.