Developing a cost-effective and efficient safety case management solution for data coordinating center projects.

A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA.

Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer's Disease (NorAD): study protocol for a randomised clinical trial and COVID-19 amendments.

Background: Guanfacine is a α2A adrenergic receptor agonist approved for treating attention deficit hyperactivity disorder (ADHD). It is thought to act via postsynaptic receptors in the prefrontal cortex, modulating executive functions including the regulation of attention. Attention is affected early in Alzheimer's disease (AD), and this may relate to pathological changes within the locus coeruleus, the main source of noradrenergic pathways within the brain.

Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data.

Introduction: The novel coronavirus SARS-CoV-2, which emerged in December 2019, has caused millions of deaths and severe illness worldwide. Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 September 2021, over 48 million people have received their first vaccine dose and over 44 million people have received their second vaccine dose across the UK.

Developing supportive local communities: Perspectives from people with dementia and caregivers participating in the IDEAL programme.

Communities play an important role in supporting people living with dementia. The aim of this study was to explore what could be changed in the local community to enable those with dementia to live well. People with dementia and carers taking part in the IDEAL programme responded to open-ended questions.

Living well with dementia: What is possible and how to promote it.

The focus on living well with dementia encourages a more positive and empowering approach. The right support can improve the experience of living with dementia. An holistic approach to assessing the needs of people with dementia and identifying the factors that impact on their well‐being is essential.

Online Education and Cognitive Behavior Therapy Improve Dementia Caregivers' Mental Health: A Randomized Trial.

Objectives: To compare online cognitive-behavioral therapy (CBT) with and without telephone support respectively to online psychoeducation in a randomized controlled trial (RCT) in caregivers of people with dementia with mild anxiety or depression.

Design: Three-arm parallel-group RCT comparing online CBT with and without telephone support respectively to online psychoeducation.

Setting And Participants: Online study with caregivers of people with dementia.

Mild cognitive impairment: the Manchester consensus.

Given considerable variation in diagnostic and therapeutic practice, there is a need for national guidance on the use of neuroimaging, fluid biomarkers, cognitive testing, follow-up and diagnostic terminology in mild cognitive impairment (MCI). MCI is a heterogenous clinical syndrome reflecting a change in cognitive function and deficits on neuropsychological testing but relatively intact activities of daily living. MCI is a risk state for further cognitive and functional decline with 5-15% of people developing dementia per year.

What Are the Benefits of Pet Ownership and Care Among People With Mild-to-Moderate Dementia? Findings From the IDEAL programme.

Pet ownership has been associated with positive outcomes in many populations, yet the associations with physical and psychological wellbeing in people with dementia remain unclear. The current study used baseline data from 1,542 people living at home with mild-to-moderate dementia from the Improving the experience of Dementia and Enhancing Active Life (IDEAL) programme. Regression analyses investigated associations of pet ownership and pet care with self-reports of walking, loneliness, depression, and quality of life (QoL).

Potential human transmission of amyloid β pathology: surveillance and risks.

Studies in experimental animals show transmissibility of amyloidogenic proteins associated with prion diseases, Alzheimer's disease, Parkinson's disease, and other neurodegenerative diseases. Although these data raise potential concerns for public health, convincing evidence for human iatrogenic transmission only exists for prions and amyloid β after systemic injections of contaminated growth hormone extracts or dura mater grafts derived from cadavers. Even though these procedures are now obsolete, some reports raise the possibility of iatrogenic transmission of amyloid β through putatively contaminated neurosurgical equipment.

Factors associated with self- and informant ratings of quality of life, well-being and life satisfaction in people with mild-to-moderate dementia: results from the Improving the experience of Dementia and Enhancing Active Life programme.

Background: a large number of studies have explored factors related to self- and informant ratings of quality of life in people with dementia, but many studies have had relatively small sample sizes and mainly focused on health conditions and dementia symptoms. The aim of this study is to compare self- and informant-rated quality of life, life satisfaction and well-being, and investigate the relationships of the two different rating methods with various social, psychological and health factors, using a large cohort study of community-dwelling people with dementia and carers in Great Britain.

Methods: this study included 1,283 dyads of people with mild-to-moderate dementia and their primary carers in the Improving the experience of Dementia and Enhancing Active Life study.

Use and costs of services and unpaid care for people with mild-to-moderate dementia: Baseline results from the IDEAL cohort study.

Introduction: We examined 3-month service use and costs of care for people with mild-to-moderate dementia in Great Britain.

Methods: We analyzed Improving the experience of Dementia and Enhancing Active Life cohort study baseline data on paid care, out-of-pocket expenditure, and unpaid care from participants with dementia (N = 1547) and their carers (N = 1283). In regression analyses, we estimated per-group mean costs of diagnostic and sociodemographic subgroups.

Tackling gaps in developing life-changing treatments for dementia.

Since the G8 dementia summit in 2013, a number of initiatives have been established with the aim of facilitating the discovery of a disease-modifying treatment for dementia by 2025. This report is a summary of the findings and recommendations of a meeting titled "Tackling gaps in developing life-changing treatments for dementia", hosted by Alzheimer's Research UK in May 2018. The aim of the meeting was to identify, review, and highlight the areas in dementia research that are not currently being addressed by existing initiatives.

A Comprehensive Model of Factors Associated With Subjective Perceptions of "Living Well" With Dementia: Findings From the IDEAL Study.

Introduction: We aimed to better understand what predicts the capability to "live well" with dementia by identifying the relative contribution of life domains associated with the subjective experience of living well.

Methods: We analyzed data from 1547 individuals with mild-to-moderate dementia in the IDEAL cohort. We generated a "living well" latent factor from measures of quality of life, satisfaction with life, and well-being.

A Comprehensive Model of Factors Associated With Capability to "Live Well" for Family Caregivers of People Living With Mild-to-Moderate Dementia: Findings From the IDEAL Study.

Introduction: Understanding key influences on outcomes for caregivers of people with dementia is hampered by inconsistent conceptualization and measurement of outcomes and limited evidence about the relative impact of different variables. We aimed to address these issues.

Methods: We analyzed data from 1283 caregivers of community-dwelling individuals with mild-to-moderate dementia in the Improving the experience of Dementia and Enhancing Active Life cohort study.

Accelerated weathering parameters for some aromatic engineering thermoplastics. Part 2: Polycarbonate copolymers, polyarylate and ABS.

Understanding the responses of materials to environmental variables is essential for performing meaningful accelerated weathering and service life prediction. Samples of polycarbonate--resorcinol polyarylate copolymer (RPA), poly(acrylonitrile--butadiene--styrene) (ABS), and two polycarbonate copolymers with silicone or aliphatic diacids were exposed in the NIST (National Institute of Standards and Technology) SPHERE (Simulated Photodegradation via High Energy Radiant Exposure) to determine the effects of ultraviolet intensity (UV irradiance), temperature, relative humidity (RH), and UV wavelength on yellowing and gloss loss and were compared to other aromatic polymers. All showed proportional response to irradiance (i.

Accelerated weathering parameters for some aromatic engineering thermoplastics.

Samples of polycarbonate (PC), poly(butylene terephthalate) (PBT), a PC/PBT blend, and poly(styrene--acrylonitrile) (SAN), all containing 3% TiO (by mass), were exposed in the NIST (National Institutes of Standards and Technology) SPHERE (Simulated Photodegradation via High Energy Radiant Exposure) to determine the effects of UV intensity (irradiance), temperature, relative humidity (RH), and UV wavelength on yellowing and gloss loss. There was no effect of irradiance, such that the samples obeyed reciprocity and doubling the irradiance doubled the rate of degradation. The activation energy for yellowing was determined to be ≈ 20 kJ/mol for PC, PC/PBT, and SAN and ≈ 16 kJ/mol for PBT.

A manual-based intervention for carers of people with dementia and sleep disturbances: an acceptability and feasibility RCT.

Background: It has been estimated that between 25% and 40% of people living with dementia suffer from sleep disturbances, and there are currently no known effective treatments. Sleep disturbances may be the direct result of dementia or due to other comorbidities, such as pain and limited mobility. If carers' sleep is also disturbed, carers too can become tired and stressed, and this sometimes results in the breakdown of care in the home.

An intervention to improve sleep for people living with dementia: Reflections on the development and co-production of DREAMS:START (Dementia RElAted Manual for Sleep: STrAtegies for RelaTives).

Many people living with dementia experience sleep disturbances yet there are currently no known effective, safe and acceptable treatments. Working with those affected by dementia to co-produce interventions is increasingly promoted to ensure that approaches are fit for purpose and meet the specific needs of target groups. Our aim here is to outline and reflect upon the co-production of Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS:START), an intervention to improve sleep for people living with dementia.

DREAMS-START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people with dementia and sleep disturbances: a single-blind feasibility and acceptability randomized controlled trial.

Unlabelled: ABSTRACTBackground:40% of people with dementia have disturbed sleep but there are currently no known effective treatments. Studies of sleep hygiene and light therapy have not been powered to indicate feasibility and acceptability and have shown 40-50% retention. We tested the feasibility and acceptability of a six-session manualized evidence-based non-pharmacological therapy; Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS-START) for sleep disturbance in people with dementia.