PMID- 30569083
OWN - NLM
STAT- MEDLINE
DCOM- 20200803
LR  - 20200803
IS  - 2426-0266 (Electronic)
IS  - 2274-5807 (Linking)
VI  - 6
IP  - 1
DP  - 2019
TI  - Pimavanserin in Alzheimer's Disease Psychosis: Efficacy in Patients with More 
      Pronounced Psychotic Symptoms.
PG  - 27-33
LID - 10.14283/jpad.2018.30 [doi]
AB  - BACKGROUND: Pimavanserin is a 5-HT2A receptor inverse agonist/antagonist and is 
      approved in the United States for the treatment of hallucinations and delusions 
      associated with Parkinson's disease psychosis. OBJECTIVE: Evaluate the efficacy 
      of pimavanserin on symptoms of psychosis in patients with Alzheimer's disease 
      (AD). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: 
      Nursing home residents. PARTICIPANTS: Patients with AD psychosis. INTERVENTIONS: 
      Pimavanserin 34 mg or placebo daily for 12 weeks. MEASUREMENTS: The primary 
      endpoint was mean change from baseline at Week 6 on the Neuropsychiatric 
      Inventory-Nursing Home Version psychosis score (NPI-NH-PS). In the prespecified 
      subgroup analysis, the mean change in NPI-NH-PS and the responder rates among 
      those with baseline NPI-NH-PS >/=12 were evaluated. RESULTS: Of 181 patients 
      randomized (n=90 pimavanserin; n=91 placebo), 57 had baseline NPI-NH-PS >/=12 (n=27 
      pimavanserin; n=30 placebo). In this severe subgroup, large treatment effects 
      were observed (delta=-4.43, Cohen's d=-0.73, p=0.011), and >/=30% improvement was 
      88.9% vs. 43.3% (p<0.001) and >/=50% improvement was 77.8% vs. 43.3% (p=0.008) for 
      pimavanserin and placebo, respectively. The rate of adverse events (AEs) in the 
      severe subgroup was similar between treatment groups, and urinary tract 
      infection, fall, and agitation were most frequent. Serious AEs was similar with 
      pimavanserin (17.9%) and placebo (16.7%) with fewer discontinuations due to AEs 
      with pimavanserin (7.1%) compared to placebo (10.0%). Minimal change from 
      baseline occurred for the mean MMSE score over 12 weeks. CONCLUSIONS: 
      Pimavanserin demonstrated significant efficacy in AD psychosis in patients with 
      higher baseline severity of psychotic symptoms (NPI-NH-PS >/=12). Treatment with 
      pimavanserin showed an acceptable tolerability profile.
FAU - Ballard, C
AU  - Ballard C
AD  - Clive Ballard, MBChB, Institute of Health Research, University of Exeter Medical 
      School, Exeter EX1 2LU, UK, C.Ballard@exeter.ac.uk.
FAU - Youakim, J M
AU  - Youakim JM
FAU - Coate, B
AU  - Coate B
FAU - Stankovic, S
AU  - Stankovic S
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Switzerland
TA  - J Prev Alzheimers Dis
JT  - The journal of prevention of Alzheimer's disease
JID - 101638820
RN  - 0 (Piperidines)
RN  - 0 (Serotonin 5-HT2 Receptor Antagonists)
RN  - 8W8T17847W (Urea)
RN  - JZ963P0DIK (pimavanserin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/complications/*drug therapy/*psychology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nursing Homes
MH  - Piperidines/adverse effects/*therapeutic use
MH  - Psychotic Disorders/*complications/*drug therapy
MH  - Serotonin 5-HT2 Receptor Antagonists/adverse effects/therapeutic use
MH  - Treatment Outcome
MH  - Urea/adverse effects/*analogs & derivatives/therapeutic use
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - Pimavanserin
OT  - psychosis
OT  - severe
COIS- Dr. Ballard has received grants and personal fees from ACADIA and Lundbeck, 
      personal fees from Heptares, Roche, Lilly, Otsuka, Orion, GlaxoSmithKline, and 
      Pfizer. JY, BC, and SS, are employees and may be stockholders in ACADIA 
      Pharmaceuticals Inc.
EDAT- 2018/12/21 06:00
MHDA- 2020/08/04 06:00
CRDT- 2018/12/21 06:00
PHST- 2018/12/21 06:00 [entrez]
PHST- 2018/12/21 06:00 [pubmed]
PHST- 2020/08/04 06:00 [medline]
AID - 10.14283/jpad.2018.30 [doi]
PST - ppublish
SO  - J Prev Alzheimers Dis. 2019;6(1):27-33. doi: 10.14283/jpad.2018.30.