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6 results

  • Dissonance in the face of Alzheimer's disease breakthroughs: clinician and lay stakeholder acceptance, concerns and willingness to pay for emerging disease-modifying therapies

  • Irina Kinchin, Sharon Walsh, Rachel Dinh, Margaret Kapuwa, Sean P. Kennelly, Ann-Marie Miller, Ann Nolan, Sean O'Dowd, Laura O'Philbin, Suzanne Timmons, Iracema Leroi
  • Journal:
    The British Journal of Psychiatry / Volume 224 / Issue 6 / June 2024
    Published online by Cambridge University Press:
    17 April 2024, pp. 230-236
    Print publication:
    June 2024
    • Article
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  • Background

    Introducing new disease-modifying therapies (DMTs) for Alzheimer's disease demands a fundamental shift in diagnosis and care for most health systems around the world. Understanding the views of health professionals, potential patients, care partners and taxpayers is crucial for service planning and expectation management about these new therapies.

    Aims

    To investigate the public's and professionals’ perspectives regarding (1) acceptability of new DMTs for Alzheimer's disease; (2) perceptions of risk/benefits; (3) the public's willingness to pay (WTP).

    Method

    Informed by the ‘theoretical framework of acceptability’, we conducted two online surveys with 1000 members of the general public and 77 health professionals in Ireland. Descriptive and multivariate regression analyses examined factors associated with DMT acceptance and WTP.

    Results

    Healthcare professionals had a higher acceptance (65%) than the general public (48%). Professionals were more concerned about potential brain bleeds (70%) and efficacy (68%), while the public focused on accessibility and costs. Younger participants (18–24 years) displayed a higher WTP. Education and insurance affected WTP decisions.

    Conclusions

    This study exposes complex attitudes toward emerging DMTs for Alzheimer's disease, challenging conventional wisdom in multiple dimensions. A surprising 25% of the public expressed aversion to these new treatments, despite society's deep-rooted fear of dementia in older age. Healthcare professionals displayed nuanced concerns, prioritising clinical effectiveness and potential brain complications. Intriguingly, younger, better-educated and privately insured individuals exhibited a greater WTP, foregrounding critical questions about healthcare equity. These multifaceted findings serve as a guidepost for healthcare strategists, policymakers and ethicists as we edge closer to integrating DMTs into Alzheimer's disease care.

  • 40 - Alzheimer’s Disease Neuroimaging Initiative

  • from Section 6 - Public–Private Partnerships in Alzheimer’s Disease Drug Development
  • Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
  • Book:
    Alzheimer's Disease Drug Development
    Published online:
    03 March 2022
    Print publication:
    31 March 2022, pp 455-464

  • Summary

    The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a longitudinal, observational study initiated in 2004 with the aim to develop and validate biomarkers for Alzheimer’s disease (AD) trials. From its inception, ADNI has been a model of a public–private partnership, with industry partners involved not only through financial support but in a guidance capacity. Through the development of standardized methods, ADNI has collected imaging and fluid biomarker data from cognitively normal, early and late mild cognitive impairment, and AD participants which is available to qualified researchers without embargo. Moreover, these methods have been incorporated into companion studies worldwide. The data that have been collected have provided important insights into the progression of AD pathology over time, assists in understanding which biomarkers may be most useful in clinical trials and have facilitated the design of studies of disease-modifying therapies.

  • 18 - Clinical Trial Development in Frontotemporal Lobar Degeneration

  • from Section 3 - Alzheimer’s Disease Clinical Trials
  • Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
  • Book:
    Alzheimer's Disease Drug Development
    Published online:
    03 March 2022
    Print publication:
    31 March 2022, pp 216-231

  • Summary

    Frontotemporal lobar degeneration (FTLD), a major cause of dementia worldwide, is an unrelenting and ultimately fatal set of pathological processes without any approved disease-modifying therapies. Clinical trial development in FTLD has previously been challenging, due to its pathological heterogeneity aand the clinical heterogeneity of frontotemporal dementia (FTD) and other clinical syndromes that arise from FTLD. Advances in FTLD basic science research have recently translated into a growing field of FTLD clinical trial development, with a particular focus on therapies tailored to distinct clinical syndromes with the highest specificity for particular FTLD pathophysiologies. The expansion of FTLD clinical programs has been fostered by a variety of advocacy groups and a number of large multi-site clinical research consortia, the latter of which have advanced the investigation of fluid biomarkers and clinical and neuroimaging measures for use in future clinical trials. This chapter covers the unique considerations of clinical trials in patients with FTLD pathology and review previous and current clinical trial programs investigating disease-modifying therapies targeting FTLD.

  • Chapter 18 - Epigenetic mechanisms in central nervous system disorders

  • Edited by James E. Barrett, Joseph T. Coyle, Michael Williams
  • Book:
    Translational Neuroscience
    Published online:
    05 July 2012
    Print publication:
    28 June 2012, pp 321-333

  • Summary

    Translational medicine is beginning to be successfully applied in multiple sclerosis (MS). This chapter reviews how advances in our understanding of MS and our ability to measure MS are contributing to the application of translational medicine in this disorder. It presents a historical perspective on the evolution of disease-modifying treatments, and then proceeds to provide a discussion on molecular pathophysiology. Next, the factors that contribute to the efficiency of translational medicine are explained. Lastly, the future of disease-modifying therapies is discussed. Interferon beta (IFNβ) was the first effective disease-modifying therapy to become available for MS. The factors that improve the efficiency of translational medicine in MS include: the identification of drug targets within well-validated biological pathways; and the use of pharmacodynamic markers, especially in early proof-of-concept and dose-ranging clinical trials. The continuing accumulation of knowledge and understanding of MS can help to accelerate the developing novel therapies for MS.

  • 28 - Mitoxantrone to treat multiple sclerosis

  • from Section III - Clinical trials of multiple sclerosis therapies
  • Edited by Jeffrey A. Cohen, Richard A. Rudick
  • Book:
    Multiple Sclerosis Therapeutics
    Published online:
    05 December 2011
    Print publication:
    20 October 2011, pp 344-357

  • Summary

    This chapter focuses on the various study designs used to estimate long-term treatment effects of disease-modifying therapies (DMTs) in multiple sclerosis (MS). It also discusses their strengths and weaknesses and the methodological challenges. Results suggest that sustained early treatment in MS patients can delay progression to significant disability and the studies support the concept that early treatment with DMTs has long-lasting effects. Long-term follow-up of patients have significant limitations, including loss of randomization and blinding, incomplete ascertainment, and the absence of an appropriate comparator. Long-term non-randomized observational trials (NROTs) include a wide range of study designs, such as prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, with the common feature that any intervention studied is determined by clinical practice and not by the protocol. Several epidemiological and statistical methods are available to deal with confounding, in both design and analytical phases of NROTs.

  • Chapter 19 - Treatment and prognosis of acute disseminated encephalomyelitis

  • from Section 4 - ADEM
  • Edited by Dorothée Chabas, University of California, San Francisco, Emmanuelle L. Waubant, University of California, San Francisco
  • Book:
    Demyelinating Disorders of the Central Nervous System in Childhood
    Published online:
    11 April 2011
    Print publication:
    17 March 2011, pp 212-222

  • Summary

    This chapter presents the literature review on disease-modifying therapies (DMT) for children with multiple sclerosis (MS). Four first-line DMTs have been approved for treatment of relapsing-remitting (RR) MS in the adult population. They include glatiramer acetate, interferon beta (IFNB)-1a IM, IFNB-1a SC, and IFNB-1b SC. Large phase III studies showed that chronic administration of recombinant IFNB reduced the number of relapses and slowed progression of physical disability in adult patients with RR MS. Abnormalities in liver function tests (LFTs) may be pronounced in younger children taking interferon. The glatiramer acetate is designed to mimic human myelin basic protein and is postulated to induce the myelin-specific response of suppressor T-lymphocytes and to inhibit specific effector T-lymphocytes. Breakthrough disease is a concern in the pediatric MS population. Proposed consensus criteria for breakthrough disease in adults include increase in relapse number, new or recurrent MRI lesions, and worsening of cognitive or motor disability.