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This database contains 52 studies, archived under the term: "research design"

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Dementia in residential care: education intervention trial (DIRECT); protocol for a randomised controlled trial

Background: There is scope to improve the quality of life (QOL) of people with dementia living in residential care facilities (RCF). The DIRECT study will determine if delivery of education to General Practitioners (GPs) and care staff improves the quality of life of residential care recipients with cognitive impairment.; Methods/design: A prospective randomised controlled trial […]

Health and nutritional promotion program for patients with dementia (NutriAlz Study): design and baseline data

Background: There is a lack of data on global weight loss prevention programs for patients with dementia or clear evidence about their impact on a functional level, caregiver burden or the use of healthcare and social resources. NutriAlz is a socio-educative and nutritional intervention program to prevent weight loss and loss of function in dementia […]

Alzheimer’s Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results

Background: The Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT) was designed to address whether non-steroidal anti-inflammatory drugs (NSAIDs) can prevent or delay the onset of Alzheimer’s disease (AD).; Methods: ADAPT was a randomized, double-placebo-controlled, multicenter chemoprevention trial conducted at six U.S. dementia research clinics. At entry, participants were required to test “normal” on a battery of […]

Cost-effectiveness of post-diagnosis treatment in dementia coordinated by Multidisciplinary Memory Clinics in comparison to treatment coordinated by general practitioners: an example of a pragmatic trial

Background: With the rising number of dementia patients with associated costs and the recognition that there is room for improvement in the provision of dementia care, the question arises on how to efficiently provide high quality dementia care.; Objective: To describe the design of a study to determine multidisciplinary memory clinics’ (MMC) effectiveness and cost-effectiveness […]

Methodological issues in the non pharmacological treatment of BPSD in nursing home–the TNM study

Behavioural and psychological symptoms of dementia (BPSD) such as agitation, aggressiveness, oppositional behaviour and psychotic symptoms are often reported by caregivers and staff members in institutions for the elderly. Taking into account the limited efficacy and the importance of side effects observed with psychotropic agents, the majority of existing guideline underlines the importance of non-pharmacological […]

DOMINO-AD protocol: donepezil and memantine in moderate to severe Alzheimer’s disease – a multicentre RCT

Background: Alzheimer’s disease (AD) is the commonest cause of dementia. Cholinesterase inhibitors, such as donepezil, are the drug class with the best evidence of efficacy, licensed for mild to moderate AD, while the glutamate antagonist memantine has been widely prescribed, often in the later stages of AD. Memantine is licensed for moderate to severe dementia […]

Dementia care initiative in primary practice: study protocol of a cluster randomized trial on dementia management in a general practice setting

Background: Current guidelines for dementia care recommend the combination of drug therapy with non-pharmaceutical measures like counselling and social support. However, the scientific evidence concerning non-pharmaceutical interventions for dementia patients and their informal caregivers remains inconclusive. Targets of modern comprehensive dementia care are to enable patients to live at home as long and as independent […]

Effectiveness of balance training exercise in people with mild to moderate severity Alzheimer’s disease: protocol for a randomised trial

Background: Balance dysfunction and falls are common problems in later stages of dementia. Exercise is a well-established intervention to reduce falls in cognitively intact older people, although there is limited randomised trial evidence of outcomes in people with dementia. The primary objective of this study is to evaluate whether a home-based balance exercise programme improves […]

Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol

Background: The growing number of people with dementia, and the increasing cost of care, provides a major incentive to develop and test methods of supporting them in the community for longer. Most attention has been given to pharmacological interventions, but there is increasing recognition that psychosocial interventions may be equally effective, even preferable where medication […]

Methodological improvements in quantifying cognitive change in clinical trials: an example with single-dose administration of donepezil

Objectives: Change in cognitive function in response to a pharmacologic challenge can be observed with greater sensitivity by employing cognitive tests with optimal psychometric properties and a statistical approach that more accurately accounts for individual variability in performance. To demonstrate this approach we examined the cognitive effects of a single acute dose administration of an […]

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