Abstract Details

Title Pimavanserin for Treatment of Comorbid Depression in Patients With Parkinson’s Disease

Topic Movement Disorders

Presentation(s) S41 - Parkinson's Disease Interventions and Clinical Trials (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

Objective To assess the utility of pimavanserin (PIM) for treatment of adults with Parkinson’s disease (PD) and depressive symptoms.

Background Depression occurs in ~50% of PD patients, increases in severity as the disease progresses, and is associated with increased morbidity.

Design/Methods This 8-week, open-label, single-arm study evaluated the safety and efficacy of PIM as an adjunct to SSRI or SNRI treatment or as monotherapy in adults with PD and depressive symptoms (baseline Hamilton Depression Scale 17-item version [HAMD-17] total score ≥15). The primary endpoint was change from Baseline to Week 8 in the HAMD-17.

Results Of the 47 patients in the safety population, 51.1% were male, and average age was 69.3 years, with 26 patients receiving PIM adjunctive therapy with SSRI/SNRI and 21 receiving PIM monotherapy. Patients in the efficacy population (N=45) had a Baseline mean(SD) HAMD-17 of 19.2(3.1). Change from Baseline to Week 8 (least squares mean(SE) in the HAMD-17 was –10.8(0.6) (95% CI; –12.0,–9.5; P<0.0001), with significant improvement seen as early as Week 2 (–7.3[0.9]; P<0.0001). HAMD-17 changes from Baseline to Week 8 were similar for adjunctive treatment and monotherapy: –10.2(0.8) and –11.2(1.0), respectively. Treatment responses (≥50% improvement on the HAMD-17) were seen in 60% of PIM-treated patients at Week 8, and 44.4% reached remission (HAMD-17 ≤7). Forty patients (85.1%) completed the study, and 7 (14.9%) terminated early (adverse event, n=3; protocol violation, n=2; lost to follow-up/other, n=1 each). Twenty-one patients reported adverse events, the most common being falls (8.5%), nausea (6.4%), diarrhea (4.3%), edema (4.3%), skin abrasion (4.3%), and urinary tract infection (4.3%).

Conclusions These data suggest that PIM treatment was associated with improvement of depressive symptoms as measured by HAMD-17 in patients with PD and well tolerated. Additional placebo-controlled data are needed to determine fully the efficacy of PIM in patients with comorbid PD and depression.

Authors/Disclosures
Victor Abler, DO (Acadia Pharmaceuticals) PRESENTER	Dr. Abler has received stock or an ownership interest from Acadia Pharmaceuticals .
Michael T. Guskey, PharmD (ACADIA Pharmaceuticals)	No disclosure on file
Gustavo Alva, MD	No disclosure on file
Jason L. Aldred, MD, FAAN (Selkirk Neurology)	Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $0-$499 for serving as a Consultant for Quadralynx. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Atara. The institution of Dr. Aldred has received research support from Takeda. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Theravance. The institution of Dr. Aldred has received research support from Triplet Therapeutics. The institution of Dr. Aldred has received research support from UCB. The institution of Dr. Aldred has received research support from Cerevel . The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from Athira. The institution of Dr. Aldred has received research support from IRL. The institution of Dr. Aldred has received research support from NeuroDerm.
	No disclosure on file
Marc Cantillon, MD, FAAN	No disclosure on file
James Norton, Jr., PhD (ACADIA Pharmaceuticals Inc.)	No disclosure on file
	No disclosure on file

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