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"Rabins, Peter V"
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Progression of Cognitive, Functional, and Neuropsychiatric Symptom Domains in a Population Cohort With Alzheimer Dementia: The Cache County Dementia Progression Study
Progression of Alzheimer dementia (AD) is highly variable. Most estimates derive from convenience samples from dementia clinics or research centers where there is substantial potential for survival bias and other distortions. In a population-based sample of incident AD cases, we examined progression of impairment in cognition, function, and neuropsychiatric symptoms, and the influence of selected variables on these domains.
Longitudinal, prospective cohort study.
Cache County (Utah).
Three hundred twenty-eight persons with a diagnosis of possible/probable AD.
Mini-Mental State Exam (MMSE), Clinical Dementia Rating sum-of-boxes (CDR-sb), and Neuropsychiatric Inventory (NPI).
Over a mean follow-up of 3.80 (range: 0.07–12.90) years, the mean (SD) annual rates of change were −1.53 (2.69) scale points on the MMSE, 1.44 (1.82) on the CDR-sb, and 2.55 (5.37) on the NPI. Among surviving participants, 30% to 58% progressed less than 1 point per year on these measures, even 5 to 7 years after dementia onset. Rates of change were correlated between MMSE and CDR-sb (r = −0.62, df = 201, p < 0.001) and between the CDR-sb and NPI (r = 0.20, df = 206, p < 0.004). Female subjects (LR χ2 = 8.7, df = 2, p = 0.013) and those with younger onset (likelihood ratio [LR] χ2 = 5.7, df = 2, p = 0.058) declined faster on the MMSE. Although one or more apolipoprotein E η 4 alleles and ever use of FDA-approved antidementia medications were associated with initial MMSE scores, neither was related to the rate of progression in any domain.
A significant proportion of persons with AD progresses slowly. The results underscore differences between population-based versus clinic-based samples and suggest ongoing need to identify factors that may slow the progression of AD.
Journal Article
Sertraline for the Treatment of Depression in Alzheimer Disease
Depression is common in Alzheimer disease (AD), and antidepressants are commonly used for its treatment, however, evidence for antidepressant efficacy in this population is lacking. The authors conducted a multicenter, randomized, placebo-controlled trial titled “Depression in Alzheimer's Disease-2” to assess the efficacy and tolerability of sertraline for depression in AD.
One hundred thirty-one participants from five U.S. medical centers with mild-to-moderate AD (Mini-Mental State Examination scores 10-26) and depression of AD were randomized to double-blinded treatment with sertraline (N = 67) or placebo (N = 64), with a target dosage of 100 mg daily. Efficacy was assessed using logistic regressions and mixed effects models in an intention-to-treat analysis with imputation of missing data. Principal outcome measures were modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC), change in Cornell Scale for Depression in Dementia (CSDD) scores, and remission defined by both mADCS-CGIC score ≤2 and CSDD score ≤6.
mADCS-CGIC ratings (odd ratio [OR = 1.01], 95% confidence interval [CI]: 0.52-1.97, p = 0.98), CSDD scores (median difference at 12 weeks 1.2, 95% CI: 1.65-4.05, p = 0.41), and remission at 12 weeks of follow-up (OR = 2.06, 95% CI: 0.84-5.04, p = 0.11) did not differ between sertraline (N = 67) and placebo (N = 64). Sertraline-treated patients experienced more adverse events, most notably gastrointestinal and respiratory, than placebo-treated patients.
Sertraline did not demonstrate efficacy for the treatment depression symptoms in patients with AD. In addition, its use was associated with an increased incidence of adverse events. Thus, selective serotonin reuptake inhibitors may be of limited value for treating depression in patients with AD.
Journal Article
Seeking Assent and Respecting Dissent in Dementia Research
Obtaining assent and respecting dissent are widely adopted safeguards when conducting dementia research involving individuals who lack consent capacity, but there is no consensus on how assent and dissent should be defined or what procedures should be used regarding them. Our objective was to provide recommendations on these issues based on the opinions of knowledgeable key informants.
Cross-sectional qualitative research.
University research institutions.
Forty informants, including 1) nationally known experts on dementia and research ethics, 2) dementia researchers, and 3) dementia caregivers and advocates.
Semistructured individual and focus group interviews, audio recorded, and transcribed for content analysis.
Assent and dissent should be defined broadly and based on an assessment of how adults who lack consent capacity can express or indicate their preferences verbally, behaviorally, or emotionally. Assent requires the ability to indicate a meaningful choice and at least a minimal level of understanding. Assent should be required whenever an individual has the ability to assent, and dissent should be binding if it is unequivocal or sustained after an effort to relieve concerns and/or distress. Standards for seeking assent and respecting dissent should not be linked to the risks or potential benefits of a study. Lacking the ability to assent and/or dissent should not automatically preclude research participation.
Obtaining assent and respecting dissent from individuals who lack consent capacity for dementia research allows them to participate, to the extent possible, in the consent process. Assent and dissent are important independent ethical constructs.
Journal Article
Changes in QTc Interval in the Citalopram for Agitation in Alzheimer's Disease (CitAD) Randomized Trial
A Food and Drug Administration (FDA) safety communication in August 2011 warned that citalopram was associated with a dose dependent risk of QT prolongation and recommended dose restriction in patients over the age of 60 but did not provide data for this age group.
CitAD was a randomized, double-masked, placebo-controlled, multicenter clinical trial for agitation in Alzheimer's disease (AD). Participants were assigned to citalopram (target dose of 30 mg/day) or placebo in a 1 ∶ 1 ratio. 186 people, 181 of whom were over the age of 60, having probable AD with clinically significant agitation were recruited from September 2009 to January 2013. After the FDA safety communication about citalopram, ECG was added to the required study procedures before enrollment and repeated at week 3 to monitor change in QTc interval. Forty-eight participants were enrolled after enhanced monitoring began.
Citalopram treatment was associated with a larger increase in QTc interval than placebo (difference in week 3 QTc adjusting for baseline QTc: 18.1 ms [95% CI: 6.1, 30.1]; p = 0.004). More participants in the citalopram group had an increase ≥ 30 ms from baseline to week 3 (7 in citalopram versus 1 in placebo; Fisher's exact p = 0.046), but only slightly more in the citalopram group met a gender-specific threshold for prolonged QTc (450 ms for males; 470 ms for females) at any point during follow-up (3 in citalopram versus 1 in placebo, Fisher's exact p = 0.611). One of the citalopram participants who developed prolonged QTc also displayed ventricular bigeminy. No participants in either group had a cardiovascular-related death.
Citalopram at 30 mg/day was associated with improvement in agitation in patients with AD but was also associated with QT prolongation.
ClinicalTrials.gov NCT00898807.
Journal Article
The 36-hour day : a family guide to caring for people who have Alzheimer disease, related dementias, and memory loss
Provides practical and legal advice on caring for those who can no longer care for themselves, including information on dealing with such daily problems as eating and exercising, and suggests ways to cope with mood swings and false ideas.
Book
Sertraline for the Treatment of Depression in Alzheimer Disease: Week-24 Outcomes
Depression and antidepressant use are common in Alzheimer disease (AD), but the effect of antidepressant treatment for depression on longer term outcomes is unknown. The authors report the Week-24 outcomes of patients who participated in a 12-week efficacy study of sertraline for depression of AD.
One hundred thirty-one participants (sertraline = 67, placebo = 64) with mild-moderate AD and depression participated in the study. Patients who showed improvement on the modified Alzheimer's Disease Cooperative Study Clinical Global Impression-Change (mADCS-CGIC) after 12 weeks of randomized treatment with sertraline or placebo continued double-blinded treatment for an additional 12 weeks. Depression response and remission at 24 weeks were based on mADCS-CGIC score and change in Cornell Scale for Depression in Dementia (CSDD) score. Secondary outcome measures included time to remission, nonmood neuropsychiatric symptoms, global cognition, function, and quality of life.
One hundred seventeen (89.3%) participants completed all study assessments and 74 (56.5%; sertraline = 38, placebo = 36) completed all 24 weeks on randomized treatment. By 24 weeks, there were no between-group differences in depression response (sertraline = 44.8%, placebo = 35.9%; odds ratio [95% CI] = 1.23 [0.64–2.35]), change in CSDD score (median difference = 0.6 [95% CI: −2.26 to 3.46], χ2 [df = 2] = 1.03), remission rates (sertraline = 32.8%, placebo = 21.8%; odds ratio [95% CI] = 1.61 [0.70–3.68]), or secondary outcomes. Common selective serotonin reuptake inhibitor-associated adverse events, specifically diarrhea, dizziness, and dry mouth, and pulmonary serious adverse events were more frequent in sertraline-randomized patients than in placebo subjects.
Sertraline treatment is not associated with delayed improvement between 12 and 24 weeks of treatment and may not be indicated for the treatment of depression of AD.
Journal Article