Study on COgnition and Prognosis in the Elderly (SCOPE): Design and Objectives.

Hypertension is a major risk factor for cardiovascular events, including stroke, as well as for white matter lesions of the brain. There is also evidence to link cognitive impairment and dementia to hypertension. However, it has not been established whether antihypertensive treatment of elderly patients with a diastolic blood pressure (DBP) in the range 90-99 mmHg provides protection against major cardiovascular events and cognitive impairment. The Study on COgnition and Prognosis in the Elderly (SCOPE) is the first study designed to assess the effects of antihypertensive drug treatment on major cardiovascular events and cognitive function in elderly patients with mild hypertension. SCOPE is a prospective, randomized, double-blind, parallel comparison of the effects of the angiotensin II type 1 (AT 1 ) receptor blocker candesartan cilexetil and placebo on major cardiovascular events (myocardial infarction [MI], stroke and cardiovascular death), cognitive function as measured by the Mini-Mental State Examination (MMSE), quality of life (QoL) and health economics. The study has included both men and women, aged 70-89 years of age, with systolic blood pressure (SBP) of 160-179 mmHg and/or DBP of 90-99 mmHg and an MMSE score of 24 or above. Nearly 5000 patients have been recruited and will be followed for a mean period of 2.5 years. After a run-in period of 1-3 months, patients were randomized to receive placebo or candesartan cilexetil, 8 mg once daily, which has been shown to provide effective and long-lasting blood pressure reductions, while maintaining placebo-like tolerability, in elderly patients. All previous antihypertensive treatment was standardized to hydrochlorothiazide (HCTZ), 12.5 mg, at enrolment. At any time during the study, the dose of study drug will be doubled if SBP rises above 160 mmHg or DBP rises above 85 mmHg. If an SBP above 160 mmHg or a DBP above 90 mmHg is observed despite the increase in study medication, additional antihypertensive medication with HCTZ is recommended. Assessments to be made during the study will include blood pressure, heart rate, ECG, MMSE, health economics and QoL. Data on adverse events and clinical events will also be collected throughout the study. SCOPE is organized and co-ordinated by an Executive Committee, a Steering Committee, an Independent Safety Committee, an Independent Event Committee and a Co-ordinating Centre. Countries participating in the Study include Belgium, Canada, Finland, France, Germany, UK, Hungary, Israel, Norway, Poland, Portugal, Spain, Sweden, The Netherlands and the USA. Inclusion of patients was completed in January 1999 and at that time 4964 patients were randomized. The baseline characteristics of these patients are shown in the Table.