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Contemp Clin Trials. 2014 Mar;37(2):200-8. doi: 10.1016/j.cct.2013.11.015. Epub 2013 Dec 5.

Donepezil treatment of older adults with cognitive impairment and depression (DOTCODE study): clinical rationale and design.

Author information

  • 1Division of Geriatric Psychiatry, New York State Psychiatric Institute, NY, USA; Department of Psychiatry, College of Physicians and Surgeons, Columbia University, NY, USA.
  • 2Department of Psychiatry, College of Physicians and Surgeons, Columbia University, NY, USA; Department of Biostatistics, Mailman School of Public Health, Columbia University, NY, USA.
  • 3Division of Geriatric Psychiatry, New York State Psychiatric Institute, NY, USA.
  • 4Department of Psychiatry, Duke University Medical Center, Durham, NC, USA.
  • 5Department of Radiology, Duke University Medical Center, Durham, NC, USA.
  • 6Department of Psychiatry, Duke University Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA; Department of Duke Institute for Brain Sciences, Duke University Medical Center, Durham, NC, USA.

Abstract

Treatment strategies for patients with depression and cognitive impairment (DEP-CI), who are at high risk to develop a clinical diagnosis of dementia, are not established. This issue is addressed in the donepezil treatment of cognitive impairment and depression (DOTCODE) pilot clinical trial. The DOTCODE study is the first long-term treatment trial that assesses differences in conversion to dementia and cognitive change in DEP-CI patients using a study design of open antidepressant medication plus add-on randomized, double-blind, placebo-controlled treatment with the acetylcholinesterase inhibitor donepezil. In Phase 1, DEP-CI patients receive optimized antidepressant treatment for 16 weeks. In Phase 2, antidepressant treatment is continued with the addition of randomized, double-blind treatment with donepezil or placebo. The total study duration for each patient is 78 weeks (18 months). Eighty DEP-CI outpatients (age 55 to 95 years) are recruited: 40 at New York State Psychiatric Institute/Columbia University and 40 at Duke University Medical Center. The primary outcome is conversion to a clinical diagnosis of dementia. The secondary outcomes are cognitive change scores in Selective Reminding Test (SRT) total recall and the modified Alzheimer's Disease Assessment Scale (ADAS-cog). Other key assessments include the 24-item Hamilton Depression Rating Scale and antidepressant response; Clinical Global Impression (CGI) for depression, cognition, and global status; neuropsychological test battery for diagnosis; informant report of functional abilities (Pfeffer FAQ); and Treatment Emergent Symptom Scale (TESS) for somatic side effects. Apolipoprotein E ε4 status, odor identification deficits, and MRI entorhinal/hippocampal cortex atrophy at baseline are evaluated as neurobiological moderators of donepezil treatment effects.

Copyright © 2013 Elsevier Inc. All rights reserved.

KEYWORDS:

Aging; Alzheimer's disease; Cognitive impairment; Depression; Donepezil; Memory decline; Randomized clinical trial

PMID:
24315979
[PubMed - in process]
PMCID:
PMC3981878
[Available on 2015/3/1]
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