title: The impact of metrifonate therapy on caregivers of patients with Alzheimer's disease: results from the MALT clinical trial. Metrifonate in Alzheimer's Disease Trial.
abstract: OBJECTIVE
  To assess the impact on burden reported by caregivers of patients with mild to moderate Alzheimer's disease (AD) who were treated with metrifonate during a randomized double blind clinical trial.
  
  
  METHODS
  Randomized clinical trial, with a 2-week screening period and a 26-week double blind, placebo controlled, treatment phase. Caregivers were assessed at baseline, at 12 weeks, and at end of trial.
  
  
  METHODS
  Caregivers were interviewed at clinics as part of the assessment of the patients.
  
  
  METHODS
  Six hundred and three caregivers of AD patients who were enrolled in the MALT trial; 591 (98%) provided data suitable for analysis at baseline, and 546 (91%) provided data allowing for inclusion in the analysis of change scores.
  
  
  METHODS
  The Caregiver Burden Assessment consisted of the Screen for Caregiver Burden, including both subjective (SCB-subj) and objective (SCB-obj) scores; the cognitive subscale of Poulshock and Deimling (PD); an abridged version of the Relatives Stress Scale (aRSS); assessments of time spent in providing care, including the Caregiver Activity Time Scale (CATS); and demographic and background variables on both the patient and caregiver.
  
  
  RESULTS
  Treatment of mild to moderate AD patients with metrifonate for a duration of 26 weeks significantly reduced the psychological burden of care to the caregivers, as measured by the SCB-subj, the PD, and the aRSS. There were no statistically significant differences on the measures assessing the time spent in caregiving, except for the caregiver's subjective impression of the change in time spent providing care during the trial. When comparing individual dose groups, most of the measures of burden showed the largest benefits in burden for the 60/80 mg group, followed by the 40/50 mg group, and then the placebo group. However, there was no statistically significant dose effect.
  
  
  CONCLUSIONS
  This study provides the first evidence from a randomized clinical trial of any acetylcholinesterase inhibitor used in the treatment of AD demonstrating a positive impact on the patient's caregiver as well as benefits to the patient. These results were shown consistently across several measurement scales and were observed after six months of treatment. These findings reinforce the clinical significance of research that has shown that metrifonate has beneficial impacts on the cognitive, behavioral, and functional abilities of AD patients. Because caregiver burden is a leading factor in the decision for institutional care placement, the ability to favorably impact that burden through pharmacological treatment of the patient is important.
authors.affiliation: MEDTAP International, Seattle, Washington, USA.
authors.forename: R
authors.initials: R
authors.lastname: Shikiar
authors.forename: A
authors.initials: A
authors.lastname: Shakespeare
authors.forename: P P
authors.initials: PP
authors.lastname: Sagnier
authors.forename: D
authors.initials: D
authors.lastname: Wilkinson
authors.forename: I
authors.initials: I
authors.lastname: McKeith
authors.forename: J F
authors.initials: JF
authors.lastname: Dartigues
authors.forename: B
authors.initials: B
authors.lastname: Dubois
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000451:nursing*; D000704:Analysis of Variance; D017028:Caregivers / Q000523:psychology*; D016009:Chi-Square Distribution; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014236:Trichlorfon / Q000627:therapeutic use*
chemical_list: D002800:Cholinesterase Inhibitors; D014236:Trichlorfon