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This database contains 27 studies, archived under the term: "clinical protocols"

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Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: study protocol for a randomized controlled trial

Background: Many older people with neuropsychiatric disorders such as Alzheimer’s disease and frontotemporal dementia suffer from sleeping problems and often show nocturnal restlessness. Professionals and informal carers face considerable problems in solving these problems. Attempts to diminish these problems with medication in a safe and responsible manner have proven hardly effective or not effective at […]

Conservative versus surgical management of idiopathic normal pressure hydrocephalus: a prospective double-blind randomized controlled trial: study protocol

There is no level I evidence to indicate whether placement of a shunt is effective in the management of idiopathic normal pressure hydrocephalus (INPH), because no trial has as yet compared the placement of a shunt versus no shunt in a randomized controlled manner. We started recruiting patients into a prospective double-blind randomized controlled study […]

The antipsychotic discontinuation in Alzheimer disease trial: clinical rationale and study design

Objectives: : Research studies on the effects of discontinuing antipsychotic medications in patients with dementia have not identified specific target symptoms or response to antipsychotics prior to discontinuation. The Antipsychotic Discontinuation in Alzheimer Disease (ADAD) trial addresses these issues in a randomized, double-blind, placebo-controlled, multicenter risperidone treatment and discontinuation trial. In Phase A, AD patients […]

Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids

Background: Stroke is a common cause of cognitive impairment and dementia. However, effective strategies for reducing the risk of post-stroke dementia remain undefined. Potential strategies include intensive lowering of blood pressure and/or lipids.; Design: multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial phase IV trial in secondary and primary care.; Participants: 100 participants from 30 UK […]

A 12-week multidomain intervention versus active control to reduce risk of Alzheimer’s disease: study protocol for a randomized controlled trial

Background: Disappointing results from clinical trials of disease-modifying interventions for Alzheimer’s dementia (AD), along with reliable identification of modifiable risk factors in mid life from epidemiological studies, have contributed to calls to invest in risk-reduction interventions. It is also well known that AD-related pathological processes begin more than a decade before the development of clinical […]

Medication adherence and tolerability of Alzheimer’s disease medications: study protocol for a randomized controlled trial

Background: The class of acetylcholinesterase inhibitors (ChEI), including donepezil, rivastigmine, and galantamine, have similar efficacy profiles in patients with mild to moderate Alzheimer’s disease (AD). However, few studies have evaluated adherence to these agents. We sought to prospectively capture the rates and reasons for nonadherence to ChEI and determine factors influencing tolerability and adherence.; Methods/design: […]

Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)

Background: Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers.; Methods/design: In this multi-centre, single-blind […]

Act In case of Depression: the evaluation of a care program to improve the detection and treatment of depression in nursing homes. Study Protocol

Background: The aim of this study is evaluating the (cost-) effectiveness of a multidisciplinary, evidence based care program to improve the management of depression in nursing home residents of somatic and dementia special care units. The care program is an evidence based standardization of the management of depression, including standardized use of measurement instruments and […]

Promotion of the mind through exercise (PROMoTE): a proof-of-concept randomized controlled trial of aerobic exercise training in older adults with vascular cognitive impairment

Background: Sub-cortical vascular ischaemia is the second most common etiology contributing to cognitive impairment in older adults, and is frequently under-diagnosed and under-treated. Although evidence is mounting that exercise has benefits for cognitive function among seniors, very few randomized controlled trials of exercise have been conducted in populations at high-risk for progression to dementia. Aerobic-based […]

The ACTION study: methodology of a trial to evaluate safety and efficacy of a higher dose rivastigmine transdermal patch in severe Alzheimer’s disease

Background: Two sizes of rivastigmine patch (5 cm(2) and 10 cm(2)) are currently approved in the US and Europe, while a 20 cm(2) rivastigmine patch has also been tested. A 15 cm(2) rivastigmine patch may provide an optimal balance between efficacy and safety. Earlier studies have demonstrated the efficacy of rivastigmine in severe Alzheimer’s disease […]

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