title: Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study.
abstract: OBJECTIVE
  To examine the efficacy and tolerability of atomoxetine (ATX) in improving cognitive performance of patients with Alzheimer dementia.
  
  
  METHODS
  A randomized, double-blind, placebo (PLA)-controlled, parallel-groups study, starting with a 5-33-day screening and evaluation period, followed by a 6-month treatment period.
  
  
  METHODS
  Eight independent or academic outpatient clinics in the United States.
  
  
  METHODS
  Male or female patients, aged 55 years and older, with mild-to-moderate Alzheimer disease (Mini-Mental State Examination score between 10 and 26) at baseline.
  
  
  METHODS
  ATX (25-80 mg/day) or PLA for up to 6 months, added to ongoing cholinesterase-inhibitor therapy.
  
  
  METHODS
  Alzheimer Disease Assessment Scale-Cognitive Portion (ADAS-Cog, primary measure), Clinician's Interview-Based Impression of Change score at end point, Neuropsychiatric Inventory, and Alzheimer's Disease Cooperative Study Inventory-Activities of Daily Living Inventory total score, safety measures (secondary measures).
  
  
  RESULTS
  Patients' (N = 92) scores on assessments of cognitive function, global clinical impression, and neuropsychiatric symptoms were not significantly different between treatment groups. Neither group showed significant changes from baseline on the primary measure of efficacy, the ADAS-Cog. The ATX group showed a significantly greater increase of heart rate, and the mean increase in diastolic blood pressure and decrease in weight differed significantly from the decrease in pressure and weight increase in the PLA group. No other clinically meaningful safety results were obtained.
  
  
  CONCLUSIONS
  Addition of ATX to ongoing cholinesterase-inhibitor therapy was generally well tolerated but did not significantly improve cognitive function.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. mohsri@lilly.com
authors.forename: Richard C
authors.initials: RC
authors.lastname: Mohs
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Shiovitz
authors.forename: Pierre N
authors.initials: PN
authors.lastname: Tariot
authors.forename: Anton P
authors.initials: AP
authors.lastname: Porsteinsson
authors.forename: Kurt D
authors.initials: KD
authors.lastname: Baker
authors.forename: Peter D
authors.initials: PD
authors.lastname: Feldman
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology; D000069445:Atomoxetine Hydrochloride; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects*; D003072:Cognition Disorders / Q000188:drug therapy / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D011437:Propylamines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018759:Adrenergic Uptake Inhibitors; D002800:Cholinesterase Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride