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Table 3 Factors that may effect global Alzheimer's disease clinical trials

From: Globalization of Alzheimer's disease clinical trials

Host factors that may affect disease progression

   General health and standard of care


Population factors that may affect drug pharmacokinetics

   Body size

   Polymorphisms of drug metabolizing enzymes

Population factors that may affect Alzheimer's disease biology

   Genotypes such as apolipoprotein E ε4 allele carrier status

   Head size

Alzheimer's disease diagnosis

   Attitudes toward aging

   Expertise in AD diagnosis

   Behavioral manifestations of AD

   Availability of advanced diagnostics, such as neuroimaging

Clinical trial instrumentation



   Perspectives on behavioral changes, such as apathy

Cultural effects on measures such as the difficulty of obtaining ADL information where domestic help is widely available

Clinical trial conduct

   Experience of investigators

   Patient and caregiver attitudes

   Training of raters

Institutional review boards and human protection

   Availability of standard AD therapies

Clinical trial data analysis

   Sample size considerations

   Extrapolation of data between countries

   Bridging studies

Regulatory factors

   Multi-regional development program requirements

   Country-specific development program requirements

Sample handling

   Sample collection and export

   Laboratory standardization procedures

Supply line factors

   Importation laws

  1. AD, Alzheimer's disease; ADL, activities of daily living.