Dataset Information

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

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 ?4 status, odor identification deficits, and MRI entorhinal/hippocampal cortex atrophy at baseline are evaluated as neurobiological moderators of donepezil treatment effects.

SUBMITTER: Pelton GH

PROVIDER: S-EPMC3981878 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Pelton Gregory H GH Andrews Howard H Roose Steven P SP Marcus Sue M SM D'Antonio Kristina K Husn Hala H Petrella Jeffrey R JR Zannas Anthony S AS Doraiswamy P Murali PM Devanand D P DP

Contemporary clinical trials 20131205 2

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 pl ...[more]

PMID: 24315979

Similar Datasets

Project description:IMPORTANCE:Problem adaptation therapy (PATH) is a treatment for older adults with major depression, cognitive impairment (from mild cognitive deficits to moderate dementia), and disability. Antidepressants have limited efficacy in this population and psychosocial interventions are inadequately investigated. OBJECTIVE:To test the efficacy of 12-week PATH vs supportive therapy for cognitively impaired patients (ST-CI) in reducing depression and disability in 74 older adults with major depression, cognitive impairment, and disability. DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial at the Weill Cornell Institute of Geriatric Psychiatry from April 1, 2006, to September 31, 2011. Interventions were administered at the participants' homes. Participants included 74 older individuals (age ? 65 years) with major depression and cognitive impairment to the level of moderate dementia. They were recruited through collaborating community agencies of Weill Cornell Institute of Geriatric Psychiatry and were randomly assigned to 12 weekly sessions of PATH or ST-CI (14.8% attrition rate). INTERVENTIONS:Home-delivered PATH vs home-delivered ST-CI. Problem adaptation therapy integrates a problem-solving approach with compensatory strategies, environmental adaptations, and caregiver participation to improve patients' emotion regulation. Supportive therapy for cognitively impaired patients focuses on expression of affect, understanding, and empathy. MAIN OUTCOMES AND MEASURES:Mixed-effects models for longitudinal data compared the efficacy of PATH with that of ST-CI in reducing depression (Montgomery-Asberg Depression Rating Scale) and disability (World Health Organization Disability Assessment Schedule II) during 12 weeks of treatment. RESULTS:Participants in PATH had significantly greater reduction in depression (Cohen d, 0.60; 95% CI, 0.13-1.06; treatment × time, F(1,179) = 8.03; P =?.005) and disability (Cohen d, 0.67; 95% CI, 0.20-1.14; treatment × time, F(1,169) = 14.86; P =?.001) than ST-CI participants during the 12-week period (primary outcomes). Furthermore, PATH participants had significantly greater depression remission rates than ST-CI participants (37.84% vs 13.51%; ?(2) = 5.74; P =?.02; number needed to treat = 4.11) (secondary outcome). CONCLUSIONS AND RELEVANCE:Problem adaptation therapy was more efficacious than ST-CI in reducing depression and disability. Problem adaptation therapy may provide relief to a large group of depressed and cognitively impaired older adults who have few treatment options. TRIALS REGISTRATION:Clinicaltrials.gov Identifier: NCT00368940.

Project description:Higher levels of optimism have been linked with positive health behaviors, biological processes, and health conditions that are potentially protective against cognitive impairment in older adults. However, the association between optimism and cognitive impairment has not been directly investigated. We examined whether optimism is associated with incident cognitive impairment in older adults.Data are from the Health and Retirement Study. Optimism was measured by using the Life Orientation Test-R and cognitive impairment with a modified version of the Telephone Interview for Cognitive Status derived from the Mini-Mental State Examination. Using multiple logistic regression models, we prospectively assessed whether optimism was associated with incident cognitive impairment in 4624 adults 65 years and older during a 4-year period.Among participants, 312 women and 190 men developed cognitive impairment during the 4-year follow-up. Higher optimism was associated with decreased risk of incident cognitive impairment. When adjusted for sociodemographic factors, each standard deviation increase in optimism was associated with reduced odds (odds ratio [OR] = 0.70, 95% confidence interval [CI] = 0.61-0.81) of becoming cognitively impaired. A dose-response relationship was observed. Compared with those with the lowest levels of optimism, people with moderate levels had somewhat reduced odds of cognitive impairment (OR = 0.78, 95% CI = 0.59-1.03), whereas people with the highest levels had the lowest odds of cognitive impairment (OR = 0.52, 95% CI = 0.36-0.74). These associations remained after adjusting for health behaviors, biological factors, and psychological covariates that could either confound the association of interest or serve on the pathway.Optimism was prospectively associated with a reduced likelihood of becoming cognitively impaired. If these results are replicated, the data suggest that potentially modifiable aspects of positive psychological functioning such as optimism play an important role in maintaining cognitive functioning.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure