General health and standard of care
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Education
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Population factors that may affect drug pharmacokinetics
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Body size
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Polymorphisms of drug metabolizing enzymes
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Population factors that may affect Alzheimer's disease biology
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Genotypes such as apolipoprotein E ε4 allele carrier status
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Head size
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Alzheimer's disease diagnosis
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Attitudes toward aging
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Expertise in AD diagnosis
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Behavioral manifestations of AD
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Availability of advanced diagnostics, such as neuroimaging
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Clinical trial instrumentation
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Translation
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Acculturation
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Perspectives on behavioral changes, such as apathy
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Cultural effects on measures such as the difficulty of obtaining ADL information where domestic help is widely available
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Clinical trial conduct
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Experience of investigators
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Patient and caregiver attitudes
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Training of raters
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Institutional review boards and human protection
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Availability of standard AD therapies
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Clinical trial data analysis
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Sample size considerations
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Extrapolation of data between countries
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Bridging studies
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Regulatory factors
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Multi-regional development program requirements
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Country-specific development program requirements
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Sample handling
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Sample collection and export
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Laboratory standardization procedures
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Supply line factors
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Importation laws
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