INTRODUCTION: Most @entity195 ( @entity195 ) clinical trials enroll @entity1 multinationally. Yet, few data exist to guide investigators and sponsors regarding the types of @entity1 enrolled in these studies and whether @entity1 characteristics vary by region. METHODS: We used data derived from four multinational phase III trials in mild to moderate @entity195 to examine whether regional differences exist with regard to @entity1 demographics, safety reporting, and baseline scores on the Mini Mental State Examination (MMSE), the 11-item @entity195 Assessment Scale-Cognitive subscale ( @entity11509 -cog11), the Clinical @entity303 Rating scale Sum of Boxes (CDR-SB), the @entity195 Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), and the Neuropsychiatric Inventory (NPI). We assigned 31 participating nations to 7 geographic regions: North America, South America/Mexico, Western Europe/Israel, Eastern Europe/Russia, Australia/South Africa, Asia, and Japan. RESULTS: North America, Western Europe/Israel, and Australia/South Africa enrolled similar proportions of @entity1 , @entity2204 carriers, and @entity1 with spouse study partners, whereas Asia, Eastern Europe/Russia, and South America/Mexico had lower proportions for these variables. North America and South America/Mexico enrolled older subjects, whereas Asia and South America/Mexico enrolled less-educated @entity1 than the remaining regions. Approved @entity195 therapy use differed among regions (range: 73% to 92%) and was highest in North America, Western Europe/Israel, and Japan. Dual therapy was most frequent in North America (48%). On the MMSE, North America, Western Europe/Israel, Japan, and Australia/South Africa had higher (better) scores, and Asia, South America/Mexico, and Eastern Europe/Russia had lower scores. Eastern Europe/Russia had more impaired @entity11509 -cog11 scores than all other regions. Eastern Europe/Russia and South America/Mexico had more impaired scores for the ADCS-ADL and the CDR-SB. Mean scores for the CDR-SB in Asia were milder than all regions except Japan. NPI scores were lower in Asia and Japan than in all other regions. @entity1 in North America and Western Europe/Israel reported more adverse events than those in Eastern Europe/Russia and Japan. CONCLUSIONS: These findings suggest that trial populations differ across geographic regions on most baseline characteristics and that multinational enrollment is associated with sample heterogeneity. The data provide initial guidance with regard to the regional differences that contribute to this heterogeneity and are important to consider when planning global trials.

Comparing recruitment, retention, and safety reporting among geographic regions in multinational XXXX clinical trials.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients', 'participant', 'Participants', 'men'] @entity11509 :: ('8540', 'Gene') :: ['ADAS'] @entity2204 :: ('348', 'Gene') :: ['apolipoprotein E   4'] @entity303 :: ('MESH:D003704', 'Disease') :: ['Dementia'] @entity195 :: ('MESH:D000544', 'Disease') :: ['AD', "Alzheimer's disease", "Alzheimer's Disease"]
@entity195 :: (MESH:D000544,Disease) :: ['Alzheimer's disease']
