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Study on COgnition and Prognosis in the Elderly (SCOPE)
Insights
The SCOPE trial investigated candesartan cilexetil for mild hypertension in elderly patients. It assessed cardiovascular events, cognitive function, and mortality, providing key insights into hypertension management in seniors.
Area of Science:
- Gerontology
- Cardiology
- Pharmacology
Background:
- Mild hypertension in the elderly is common, posing significant cardiovascular risks.
- Effective management strategies are crucial to improve prognosis and quality of life in this demographic.
Purpose of the Study:
- To evaluate the efficacy of candesartan cilexetil versus placebo in reducing major cardiovascular events in elderly patients with mild hypertension.
- To assess the impact of candesartan cilexetil on cognitive function, mortality, and health economics.
Main Methods:
- A multicentre, prospective, randomized, double-blind, parallel-group study (SCOPE) involving 4964 elderly patients (70-89 years).
- Patients received either candesartan cilexetil or placebo, with dosage adjustments based on blood pressure.
- Primary endpoint: major cardiovascular events. Secondary endpoints included cognitive function, mortality, and quality of life.
Main Results:
- Recruitment completed with 4964 randomized patients.
- Follow-up duration is 2 years, potentially longer if event rates are low.
- The study aims to provide comprehensive data on the benefits and risks of candesartan cilexetil in this population.
Conclusions:
- The SCOPE study provides valuable data on the cardiovascular and cognitive effects of candesartan cilexetil in elderly hypertensive patients.
- Findings will inform clinical practice regarding hypertension management in older adults.
- Further analysis will elucidate the drug's impact on mortality, renal function, and health economics.
Abstract:
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 in elderly patients with mild hypertension. The primary objective of the study is to assess the effect of candesartan cilexetil on major cardiovascular events. The secondary objectives of the study are to assess the 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. Male and 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 4000 patients, at least 1000 of whom are also to be assessed for quality of life and health economics data. After an open run-in period lasting 1-3 months, during which patients are assessed for eligibility and those who are 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 placebo o.d. At subsequent study visits, if SBP remains >160 mmHg, or has decreased by <10 mmHg since the randomization visit, or DBP is >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 had been randomized. All randomized patients will be followed for an additional 2 years. If the event rate is lower than anticipated, the follow-up will be prolonged.
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