AN OPEN-LABEL TRIAL OF YOKUKANSAN ON SLEEP DISTURBANCE IN ALZHEIMER’S DISEASE AND OTHER DEMENTIA

2015 ◽  
pp. 1-6
Author(s):  
Y. Hayashi ◽  
Y. Ishida ◽  
K. Okahara ◽  
Y. Mitsuyama
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Sleep Disturbances ◽  
Sleep Onset ◽  
Therapeutic Interventions ◽  
Secondary Outcome ◽  
Neuropsychiatric Inventory ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Trial

Background: An effective hypnotic drug with a low risk of adverse reactions is required for Alzheimer’s disease (AD) patients, because the therapeutic interventions to improve sleep quality may help alleviate some symptoms of AD including cognitive function. Objective: The aim of this study was to investigate the efficacy and safety of Yokukansan in sleep disturbances in patients with AD and other dementia. Design: An open-label trial. Setting: Two sites consist of university and hospital in Japan. Participants: Thirteen patients (7 men and 6 women, average age = 76.0 ± 7.2 (mean ± SD) years old) including 12 AD and 1 frontotemporal dementia. Intervention: Treatment with Yokukansan (5–7.5 g/day) was given for 8 weeks. Measurements: The primary outcome measure was the Sleep Disorder Inventory (SDI) based on the Neuropsychiatric Inventory, an instrument developed by the Alzheimer’s Disease Cooperative Study. Secondary outcome measures included the objective actigraphic evaluations, Neuropsychiatric Inventory-Questionnaire (NPI-Q), MINI-Mental State Examination (MMSE). These assessments were evaluated at baseline, and weeks 4 and 8. Results: After 4 and 8 weeks treatment with Yokukansan, significant improvements were observed in the SDI total score, caregivers’ distress score, and NPI-Q total score. In actigraph data, wake after sleep onset (WASO) time (min), was significantly improved. The MMSE score did not change during the treatment. No serious adverse events were caused by YKS. Conclusion: The present results suggest that Yokukansan is safe and beneficial in the treatment of sleep disturbances and that it can possibly reduce the burden of care of demented patients.

scholarly journals Different Apathy Profile in Behavioral Variant of Frontotemporal Dementia and Alzheimer's Disease: A Preliminary Investigation

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Davide Quaranta ◽  
Camillo Marra ◽  
Concettina Rossi ◽  
Guido Gainotti ◽  
Carlo Masullo
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Frontotemporal Dementia ◽  
Sleep Disturbances ◽  
Preliminary Investigation ◽  
Univariate Analysis ◽  
Behavioral Changes ◽  
Neuropsychiatric Inventory ◽  
Multivariate Logistic Regression ◽  
Clinical Expression

Apathy is one of the most common behavioral symptoms of dementia; it is one of the salient features of behavioral variant of frontotemporal dementia (bvFTD) but is also very frequent in Alzheimer's disease. This preliminary investigation was aimed at assessing the type of apathy-related symptoms in a population of bvFTD and AD subjects showing comparable apathy severity. Each patient underwent a comprehensive neuropsychological assessment; behavioral changes were investigated by the neuropsychiatric inventory (NPI), using the NPI-apathy subscale to detect apathetic symptoms. At univariate analysis, bvFTD subjects showed lack of initiation (χ2=4.602,p=0.032), reduced emotional output (χ2=6.493,p=0.008), and reduced interest toward friends and family members (χ2=4.898,p=0.027), more frequently than AD subjects. BvFTD displayed higher scores than AD on NPI total score (p=0.005) and on subscales assessing agitation (p=0.004), disinhibition (p=0.007) and sleep disturbances (p=0.025); conversely, AD subjects were more impaired on memory, constructional abilities, and attention. On multivariate logistic regression, reduced emotional output was highly predictive of bvFTD (OR=18.266;p=0.008). Our preliminary findings support the hypothesis that apathy is a complex phenomenon, whose clinical expression is conditioned by the site of anatomical damage. Furthermore, apathy profile may help in differentiating bvFTD from AD.

A Large, Community-Based, Open-Label Trial of Donepezil in the Treatment of Alzheimer’s Disease

2003 ◽  
Vol 16 (1) ◽  
pp. 15-24 ◽  
Author(s):  
Norman R. Relkin ◽  
William E. Reichman ◽  
John Orazem ◽  
Thomas McRae
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Open Label ◽  
Community Based ◽  
Large Community ◽  
Open Label Trial

[P-205]: Safety and efficacy of donepezil in a 12-week, open-label trial in African Americans with mild to moderate Alzheimer's disease

2005 ◽  
Vol 1 ◽  
pp. S73-S73
Author(s):  
Patrick Griffith ◽  
Peter Lichtenberg ◽  
Robert Goldman ◽  
Lynn Burger ◽  
June Lato ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
African Americans ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Trial

scholarly journals OBJECTIVELY MEASURED SLEEP CHARACTERISTICS OF OLDER ADULTS WITH AND WITHOUT ALZHEIMER’S DISEASE

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S1-S2
Author(s):  
Alex Laffer ◽  
Hilary J Hicks ◽  
Genna Losinski ◽  
Amber Watts
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Sleep Disturbances ◽  
Sleep Onset ◽  
Living Environment ◽  
Sleep Onset Latency ◽  
Significant Group ◽  
Time In Bed ◽  
Increased Risk

Abstract Older adults commonly experience disturbed sleep such as difficulty initiating or maintaining sleep. Older adults who experience impaired sleep are at increased risk for cognitive decline or developing Alzheimer’s disease (AD). Research has shown that people with AD experience changes in sleep patterns, however, these changes are not well characterized. To better understand sleep in an older adult population with and without AD, the present study aimed to describe and compare objective sleep characteristics in both. Participants were older adults (126 with and 41 without AD) who wore an ActiGraph GT9X monitor on their non-dominant wrist for 7 days in a free-living environment. Results suggest that, compared to those without AD, participants with AD spent significantly more time in bed, t (165) = -4.37, p = .001), slept for longer durations, t (165) = -2.39, p = .044), and had less efficient sleep, t (165) = 2.71, p = .007. Participants with AD also had significantly greater sleep onset latency, more time awake after sleep onset, longer awakening lengths, and tended to arise later in the morning (all p ≤ .016). No differences were found between the groups in age, bedtime, or the number of awakenings during the night. These findings add to our understanding of the sleep disturbances experienced by older adults with and without AD. Significant group differences suggest that interventions may be necessary in treating sleep disturbances for older adults with and without AD. Future studies should examine sleep longitudinally to understand risk factors related to AD.

scholarly journals Senolytic Therapy to Modulate the Progression of Alzheimer’s Disease (SToMP-AD): A Pilot Clinical Trial

2021 ◽  
pp. 1-8
Author(s):  
M.M. Gonzales ◽  
V.R. Garbarino ◽  
E. Marques Zilli ◽  
R.C. Petersen ◽  
J.L. Kirkland ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Early Stage ◽  
Primary Objective ◽  
Secondary Outcome ◽  
Protein Accumulation ◽  
Open Label ◽  
Double Blind ◽  
Organ Systems

Preclinical studies indicate an age-associated accumulation of senescent cells across multiple organ systems. Emerging evidence suggests that tau protein accumulation, which closely correlates with cognitive decline in Alzheimer’s disease and other tauopathies, drives cellular senescence in the brain. Pharmacologically clearing senescent cells in mouse models of tauopathy reduced brain pathogenesis. Compared to vehicle treated mice, intermittent senolytic administration reduced tau accumulation and neuroinflammation, preserved neuronal and synaptic density, restored aberrant cerebral blood flow, and reduced ventricular enlargement. Intermittent dosing of the senolytics, dasatinib plus quercetin, has shown an acceptable safety profile in clinical studies for other senescence-associated conditions. With these data, we proposed and herein describe the objectives and methods for a clinical vanguard study. This initial open-label clinical trial pilots an intermittent senolytic combination therapy of dasatinib plus quercetin in five older adults with early-stage Alzheimer’s disease. The primary objective is to evaluate the central nervous system penetration of dasatinib and quercetin through analysis of cerebrospinal fluid collected at baseline and after 12 weeks of treatment. Further, through a series of secondary outcome measures to assess target engagement of the senolytic compounds and Alzheimer’s disease-relevant cognitive, functional, and physical outcomes, we will collect preliminary data on safety, feasibility, and efficacy. The results of this study will be used to inform the development of a randomized, double-blind, placebo-controlled multicenter phase II trial to further explore of the safety, feasibility, and efficacy of senolytics for modulating the progression of Alzheimer’s disease. Clinicaltrials.gov registration number and date: NCT04063124 (08/21/2019).

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