Eligibility of Alzheimer's Disease Clinic Patients for Clinical Trials

This study reviews the published literature on racial and ethnic disparities among people with Alzheimer’s disease (AD) and related dementias in the United States. To identify relevant studies, we searched electronic sources for peer-reviewed journal articles and unpublished research reports that were published through July 2014; related to the AD population and their caregivers; and provided evidence of racial and ethnic disparities, discussed reasons for disparities, or described interventions to address disparities. The literature shows consistent and adverse disparities among blacks and Hispanics compared with non-Hispanic whites concerning AD, including the disease’s prevalence and incidence, mortality, participation in clinical trials, use of medications and other interventions, use of long-term services and supports, health care expenditures, quality of care, and caregiving. The literature suggests numerous underlying causes, including factors related to measurement of the disease, genetics, socioeconomic factors, cultural differences, lack of culturally competent clinicians, and discrimination. Although these disparities are well known, little is known about the effectiveness of various strategies, such as cultural competence training, to address these differences, and very few studies evaluate possible interventions.

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“…Black and Hispanic adults were less likely than whites to qualify for inclusion (Schneider, Olin, Lyness, & Chui, 1997).…”

Section: Participation In Research Studiesmentioning

confidence: 99%

Racial and Ethnic Disparities Among Individuals with Alzheimer’s Disease in the United States: A Literature Review

Lines¹,

Sherif²,

Wiener³

2014

115

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“…Individuals participating in clinical trials tend to be younger, with a higher level of education and a better financial situation than patients not included in the trials. 56,57 These individuals might deteriorate differently over the longer term and have lower mortality rates than the nonparticipants. A naturalistic study enrolls ordinary patients from a routine clinical setting using wide inclusion criteria, e.g., acceptance of coexisting illnesses and concomitant medications.…”

Section: Discussionmentioning

confidence: 99%

Prediction Models for Assessing Long-Term Outcome in Alzheimer’s Disease

Wattmo

2013

Am J Alzheimers Dis Other Demen

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In Alzheimer's disease (AD), placebo-controlled long-term studies of cholinesterase inhibitors (ChEIs) are not permitted for ethical reasons. Therefore, in these studies, patients' outcomes on cognitive and functional assessment scales must be compared with mathematical models or historical data from untreated cohorts. PubMed and previously published long-term extensions of clinical trials and naturalistic studies of ChEIs were examined to identify empirical statistical models and other approaches, such as use of data from historical cohorts or extrapolated changes from extension studies, that were used to draw comparisons between ChEI-treated and untreated patients. The models and methods were described. It is essential to be aware of the limitations of comparisons made with these approaches. Prediction models based on ChEI-treated patients can be used in studies of new treatments when those treatments are added to ChEIs. More sophisticated models that also accommodate patientspecific characteristics should be developed for comparisons in future long-term AD studies.

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“…Most subjects who participate in clinical trials are recruited from academic centers and are no more representative of the general population of AD patients than those who have been studied with PET. 60 Therefore, studies that may wish to use PET to monitor therapy or assess diagnosis in these individuals are well justified. In essence, the utility of both PET and SPECT need to be evaluated with regard to the specific situation.…”

Section: Remaining Questionsmentioning

confidence: 99%

Molecular neuroimaging in Alzheimer’s disease

Jagust

2004

Neurotherapeutics

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Summary: Considerable data exist to support the use of positron emission tomography (PET) and single photon emission computed tomography (SPECT) scanning as biomarkers for Alzheimer's disease (AD). The techniques are reasonably sensitive and specific in differentiating AD from normal aging, and recent studies with pathological confirmation show good sensitivity and specificity in differentiating AD from other dementias. These techniques also can detect abnormalities in groups of asymptomatic and presymptomatic individuals and may be able to predict decline to dementia. However, there are a number of existing questions related to the use of these techniques in samples that are fully representative of the spectrum of patients with dementia. For example, it is unclear how well PET and SPECT perform in comparison to a clinical diagnosis obtained in the same patient group, when autopsy is used as a gold standard. It will also be important to know what PET and SPECT add to the certainty of diagnosis in addition to the standard clinical diagnosis. Despite these unanswered questions, PET and SPECT may have application as biomarkers for AD in a number of clinical and research settings, especially in academic centers, where most of the existing studies have been done.

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Eligibility of Alzheimer's Disease Clinic Patients for Clinical Trials

Abstract: Selection criteria for AD clinical trials result in a demographically and clinically constrained subgroup that is not representative of the overall clinic population.

Cited by 117 publications

References 15 publications

Racial and Ethnic Disparities Among Individuals with Alzheimer’s Disease in the United States: A Literature Review

Racial and Ethnic Disparities Among Individuals with Alzheimer’s Disease in the United States: A Literature Review

Prediction Models for Assessing Long-Term Outcome in Alzheimer’s Disease

Molecular neuroimaging in Alzheimer’s disease

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