Study on COgnition and Prognosis in the Elderly (SCOPE): Baseline characteristics

The Study an COgnition and Prognosis in the Elderly (SCOPE) is a multi-cent re, prospective, randomized, double-blind, parallel group study. The primar y objective of SCOPE is to assess the effect of the angiotensin II type 1 ( AT(1)) receptor blocker, candesartan cilexetil 8-16 mg once daily, on major cardiovascular events in elderly patients (70-89 years of age) with mild h ypertension (DBP 90-99 and/or SEP 160-179 mmHg). The secondary objectives o f the study are to test the hypothesis that antihypertensive therapy can pr event cognitive declin (as measured by the Mini Mental State Examination, M MSE) and dementia, and to assess the effect of therapy on total mortality, myocardial infarction (MI), stroke, renal function, and hospitalization. A total of 4964 patients from 15 participating countries were recruited durin g the randomization phase of SCOPE, exceeding the target population of 4000 . The mean age of the patients at enrolment was 76 years, the ratio of male to female patients was approximately 1:2, and 52% of patients were already being treated with an antihypertensive agent at enrolment. The majority of patients (88%) were educated to at least primary school level. At randomiz ation, mean sitting blood pressure values were SEP 166 mmHg and DBP 90 mmHg , and the mean MMSE score was 28. Previous cardiovascular disease in the st udy population included myocardial infarction (4%), stroke (4%) and atrial fibrillation (4%). Men, more often than women, had a history of previous MI, stroke and atrial fibrillation. A greater percentage of men were smokers (13% vs 6% in women ) and had attended university (11% vs 3% of women). Of the randomized patie nts, 21% were 80 years of age. In this age group smoking was less common (4 % vs 10% for 70-79-year-olds) and fewer had attended university (4% vs 7% f or 70-79-year-olds) The incidence of MI was similar in both age groups. How ever, stroke and atrial fibrillation had occurred approximately twice as fr equently in the older patients. The patients' mean age at baseline was similar in the participating countri es, and most countries showed the approximate 1:2 ratio for male to female patients. There was also Little inter-country variation in terms of mean SE P, DBP or MMSE score. However, there was considerable regional variation in the percentage of patients on therapy prior to enrolment.