An MRI substudy of a donepezil clinical trial in mild cognitive impairment.
A magnetic resonance imaging (MRI) study was conducted as part of an intervention study in subjects with amnestic mild cognitive impairment (aMCI) to assess donepezil's treatment effect on brain atrophy. Adults with aMCI were randomly assigned to double-blind treatment with 10 mg/day donepezil hydrochloride or placebo for 48 weeks. Brain MRI scans were acquired at baseline and endpoint. The primary outcome measure was annualized percentage change (APC) in hippocampal volume; the main secondary outcome measure was APC in whole brain volumes. An analysis of variance (ANOVA) model including terms for treatment, site, and age was used to compare the treatment groups. APCs for hippocampal volumes were not significantly different between treatment groups. There were significant differences favoring the donepezil group for total (p = 0.001), ventricular region (p = 0.0002), and cortical region (p = 0.003) whole brain volumes. Although the primary MRI outcome measure was negative, the main secondary MRI outcome measure showed a positive result. These findings suggest a treatment effect of donepezil on brain atrophy in aMCI.
Schuff
Norbert
N
Center for Imaging of Neurodegenerative Disease, Veterans Affairs Medical Center, 114M, 4150 Clement St., San Francisco, CA 94121, USA. Norbert.Schuff@ucsf.edu
Suhy
Joyce
J
Goldman
Robert
R
Xu
Yikang
Y
Sun
Yijun
Y
Truran-Sacrey
Diana
D
Murthy
Anita
A
D000368:Aged; D000369:Aged, 80 and over; D001921:Brain / Q000187:drug effects / Q000473:pathology; D060825:Cognitive Dysfunction / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000494:pharmacology / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000494:pharmacology / Q000627:therapeutic use*; D016037:Single-Blind Method
D007189:Indans; D010880:Piperidines; D000077265:Donepezil