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Table 3 Factors that may effect global Alzheimer's disease clinical trials
| Host factors that may affect disease progression |
|---|
| General health and standard of care |
| Education |
| 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 |
| Translation |
| Acculturation |
| 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 |
