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

Abstract

The Study on COgnition and Prognosis in the Elderly (SCOPE) is a multi-centre, prospective,randomized, double-blind, parallel-group study. The primary objective of SCOPE is to assess the effect ofthe angiotensin II type 1 (AT1) receptor blocker, candesartan cilexetil 8–16 mg once daily, on majorcardiovascular events in elderly patients (70–89 years of age) with mild hypertension (DBP 90–99 and/orSBP 160–179 mmHg). The secondary objectives of the study are to test the hypothesis thatantihypertensive therapy can prevent cognitive decline (as measured by the Mini Mental StateExamination, MMSE) and dementia, and to assess the effect of therapy on total mortality, myocardialinfarction (MI), stroke, renal function, and hospitalization. A total of 4964 patients from 15 participatingcountries were recruited during the randomization phase of SCOPE, exceeding the target population of4000. The mean age of the patients at enrolment was 76 years, the ratio of male to female patients wasapproximately 1:2, and 52% of patients were already being treated with an antihypertensive agent atenrolment. The majority of patients (88%) were educated to at least primary school level. Atrandomization, mean sitting blood pressure values were SBP 166 mmHg and DBP 90 mmHg, and themean MMSE score was 28. Previous cardiovascular disease in the study population included myocardialinfarction (4%), stroke (4%) and atrial fibrillation (4%).Men, more often than women, had a history of previous MI, stroke and atrial fibrillation. A greaterpercentage of men were smokers (13% vs 6% in women) and had attended university (11% vs 3% ofwomen). Of the randomized patients, 21% were 80 years of age. In this age group smoking was lesscommon (4% vs 10% for 70–79-year-olds) and fewer had attended university (4% vs 7% for 70–79-yearolds).The incidence of MI was similar in both age groups. However, stroke and atrial fibrillation hadoccurred approximately twice as frequently in the older patients.The patients' mean age at baseline was similar in the participating countries, and most countriesshowed the approximate 1:2 ratio for male to female patients. There was also little inter-country variationin terms of mean SBP, DBP or MMSE score. However, there was considerable regional variation in thepercentage of patients on therapy prior to enrolment.