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Should EOAD patients be included in clinical trials?
Kinga Szigeti1, Rachelle S Doody
1Department of Neurology and Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, 7200B Cambridge Street, Suite E5,101, Houston, TX 77030, USA. rdoody@bcm.edu.
Alzheimer'S Research & Therapy
|February 25, 2011
Summary
Early-onset Alzheimer disease (AD) presents unique challenges, impacting younger individuals and families disproportionately. This review contrasts early- and late-onset AD, highlighting disparities in research and ethical concerns.
Area of Science:
- Neurodegenerative Diseases
- Gerontology
- Clinical Neurology
Background:
- Alzheimer disease (AD) affects 1 in 68 individuals.
- A common but arbitrary cutoff of 65 years distinguishes early- and late-onset AD.
- Most clinical trials focus on late-onset AD, potentially overlooking early-onset cases.
Purpose of the Study:
- To compare and contrast early- and late-onset AD.
- To analyze clinical, neuropsychological, imaging, genetic, biomarker, and pathological features.
- To discuss ethical considerations regarding clinical trial inclusion.
Main Methods:
- Literature review and comparative analysis.
- Examination of clinical, imaging, genetic, and pathological data.
- Ethical framework analysis.
Main Results:
- Early-onset AD, though less prevalent, impacts the active working population, causing significant individual and familial distress.
- Distinct clinical and pathological profiles may exist between early- and late-onset AD.
- Exclusion of early-onset AD patients from trials raises ethical questions of justice and non-abandonment.
Conclusions:
- The arbitrary age cutoff for AD onset requires re-evaluation.
- Further research is needed to understand the specific characteristics of early-onset AD.
- Ethical guidelines must ensure equitable access to clinical trials for all AD patient groups.
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