Obstacles And Opportunities In Alzheimer’s Clinical Trial Recruitment

Watson, Jennifer; Ryan, Laurie; Silverberg, Nina; Cahan, Vicky; Bernard, Marie A.

doi:10.1377/hlthaff.2013.1314

Cited by 149 publications

(187 citation statements)

References 25 publications

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“…Difficulty in participant recruitment is a major reason for both lengthening the duration of clinical trials and increasing their costs, thus reducing efficiency. The struggle to enroll participants is a long-standing problem, dating back at least to the mid-1990s [9], and is a widespread difficulty for most dementia clinical trials and longitudinal studies [10][11][12][13].…”

Section: The Problemmentioning

confidence: 99%

The crisis in recruitment for clinical trials in Alzheimer's and dementia: An action plan for solutions

Fargo

Carrillo

Weiner

et al. 2016

Alzheimer's & Dementia

100

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Section: The Problemmentioning

confidence: 99%

The crisis in recruitment for clinical trials in Alzheimer's and dementia: An action plan for solutions

Fargo

Carrillo

Weiner

et al. 2016

Alzheimer's & Dementia

100

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“…Regardless of limited symptomatic treatment, there are no proven disease‐modifying interventions. Despite huge and growing costs of care, a pipeline of candidate drugs, >400 registered trials, tens of thousands of patients, billions of dollars in both US federal and pharmaceutical company investment, more than a century of clinical expertise, and thousands of professional careers, dozens of pharmaceutical and biotechnology firms have foundered and failed in attempts to prevent, slow, or alter the course of the dementias.…”

Section: Part 1: the Need For A Modelmentioning

confidence: 99%

A unified model of dementias and age‐related neurodegeneration

Fossel

2020

Alzheimer's & Dementia

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Those working with Alzheimer's and other dementias have been frustrated by the implacability of these diseases. Regardless of limited symptomatic treatment, 1 there are no proven disease-modifying interventions. Despite huge and growing costs of care, 2 a pipeline of candidate drugs, 3 >400 registered trials, 4 tens of thousands of patients, 5 billions of dollars in both US federal 6 and pharmaceutical company investment, 7,8 more than a century of clinical expertise, and thousands of professional careers, dozens of pharmaceutical and biotechnology firms have foundered and failed 9 in attempts to prevent, slow, or alter the course of the dementias.This article presents a novel model to explain the relationships between age-related neurodegenerative disorders (eg, dementias) and the underlying molecular mechanisms of the aging process. The hypothesis is prompted by the fact that accepted conceptual models have failed to yield effective interventions for Alzheimer's or other dementias. 10 This article is a specific response to the Alzheimer's & Dementia editorial of November 2015, 11 which called for a systemic re-evaluation of our current models and their ability to answer fundamental questions regarding complex brain disorders and their relationship to clinical dementia, as well as the failure to yield effective clinical interventions.The article is divided into three parts. The first part explores current models of age-related neurogenerative diseases. The second part proposes a specific model and details both its working and its implications.The third part applies the model to answering the 10 key questions proposed by the Alzheimer's & Dementia editorial. The intent is to provide a conceptual model that accords with known data and proposes a novel point of clinical intervention. The model is intended to provoke discussion and provide a point of departure, rather than to offer a complete and final model for age-related neurodegenerative disease. The value of any such model rests on the outcome of clinical trials, but the model offers potentially innovative pathways to such trials. Current dementia modelsAlthough there is no general explanation for the failure to identify an effective intervention, there is growing consensus that a major factor is the lack of a comprehensive model for the dementias. 12 Over the past century, 13 several models have attained varying degrees of acceptance.Such models generally assume (or imply) a predominant single cause of Alzheimer's disease (AD; Figure 1).Such models suggest that, although several factors may contribute to the pathology, most Alzheimer's pathology results from a single predominant cause, such as amyloid plaque. In Figure 1, A (the predominant cause) is the leading causal factor, whereas B, C, D, and E represent contributing (but less significant or even incidental) factors.Until recently, the foremost among such explanations has been amyloid (A ) theory, [14][15][16][17] in various iterations. Other candidates have been tau tangles, 18-20 mitochondrial dysfun...

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“…experienced at least one fall in the last 6 months and / or scored moderate or high risk of falls in their last falls risk (FRASE) screening; (2) likely to benefit from taking part in a falls prevention programme in TC and / or nursing home physiotherapist's professional opinion. Residents were excluded if the following applied: (1) are bed or chair bound (2) require assistance of two people to walk; (3) had falls due to polypharmacy or unknown reasons; (4) are clinically unstable according to TC; (5) are not likely to benefit from participating in the falls prevention programme for any reason in TC's / the nursing home physiotherapist's professional opinion (6) are fitted with a pacemaker.…”

Section: Sampling and Participantsmentioning

confidence: 99%

“…Older adults, particularly those with impaired mobility and/or cognitive disorders such as dementia, are typically under recruited in clinical trials, even though they experience the greatest need for healthcare services [1][2][3][4][5][6]. Reasons for underrepresentation are disparate but may relate to comorbidities, communication difficulties (due to hearing or vision impairment), and physical immobility that constrains transportation to a research site [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study (Preprint)

Donnelly¹,

Reginatto²,

Kearns³

et al. 2017

Preprint

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BACKGROUND Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. OBJECTIVE The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. METHODS Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities co-ordinator, and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. RESULTS Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. CONCLUSIONS A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.

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Obstacles And Opportunities In Alzheimer’s Clinical Trial Recruitment

Cited by 149 publications

References 25 publications

The crisis in recruitment for clinical trials in Alzheimer's and dementia: An action plan for solutions

The crisis in recruitment for clinical trials in Alzheimer's and dementia: An action plan for solutions

A unified model of dementias and age‐related neurodegeneration

The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study (Preprint)

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