Study on COgnition and Prognosis in the Elderly (SCOPE)

Hansson L, Lithell H, Skoog I, Baro F, Ba´nki CM, Breteler M, Carbonin PU, Castaigne A, CorreiaM, Degaute J-P, Elmfeldt D, Engedal K, Farsang C, Ferro J, Hachinski V, Hofman A, James OFW,Krisin E, Leeman M, De Leeuw PW, Leys D, Lobo A, Nordby G, Olofsson B, Opolski G, Prince M,Reischies FM, Rosenfeld JB, Ruilope L, Salerno J, Tilvis R, Trenkwalder P, Zanchetti A. Study oncognition and prognosis in the elderly (SCOPE). Blood Pressure 1999; 8: 177–183.The Study on COgnition and Prognosis in the Elderly (SCOPE) is a multicentre, prospective, randomized,double-blind, parallel-group study designed to compare the effects of candesartan cilexetil and placebo inelderly patients with mild hypertension. The primary objective of the study is to assess the effect ofcandesartan cilexetil on major cardiovascular events. The secondary objectives of the study are to assessthe effect of candesartan cilexetil on cognitive function and on total mortality, cardiovascular mortality,myocardial infarction, stroke, renal function, hospitalization, quality of life and health economics. Maleand female patients aged between 70 and 89 years, with a sitting systolic blood pressure (SBP) of 160–179 mmHg and/or diastolic blood pressure (DBP) of 90–99 mmHg, and a Mini-Mental State Examination(MMSE) score of 24 or above, are eligible for the study. The overall target study population is 4000patients, at least 1000 of whom are also to be assessed for quality of life and health economics data. Afteran open run-in period lasting 1–3 months, during which patients are assessed for eligibility and those whoare already on antihypertensive therapy at enrolment are switched to hydrochlorothiazide 12.5 mg o.d.,patients are randomized to receive either candesartan cilexetil 8 mg once daily (o.d.) or matching placeboo.d. At subsequent study visits, if SBP remains >160 mmHg, or has decreased by 85 mmHg, study treatment is doubled to candesartan cilexetil 16 mg o.d.or two placebo tablets o.d. Recruitment was completed in January 1999. At that time 4964 patients hadbeen randomized. All randomized patients will be followed for an additional 2 years. If the event rate islower than anticipated, the follow-up will be prolonged.