Effects of temporary discontinuation of antihypertensive treatment in older patients with cognitive impairment: A randomised controlled trial.
- Conditions
- antihypertensive therapy - cognitive functioning - elderly
- Registration Number
- NL-OMON26485
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Age ≥ 75 years;
2. Current antihypertensive treatment;
Exclusion Criteria
1. A history of myocardial infarction, stroke, coronary reperfusion procedures (CABG/PCI) < 3 years;
2. Heart failure requiring antihypertensive medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is the change in the compound cognitive score between baseline and follow-up at 4 months after randomisation (At baseline and at 4 months follow-up, from all patients a number of cognitive measurements will be obtained: MMSE, for global cognitive functioning, Stroop-Colour Word Test (SCWT) and Trail Making Test (TMT) for executive functioning, 15-Word Verbal Learing Test (15-WVLT) and Visual Association Test (VAT) for (immediate and delayed) verbal and picture memory, and Letter-Digit Substitution Test (LDST) for psychomotor speed. The six aforementioned cognitive tests will be combined in a cognitive compound score.
- Secondary Outcome Measures
Name Time Method At baseline and at 4 months follow-up, moreover, the Neuropsychiatric Inventory (NPI) will be carried out for, among others, assessment of depression and apathy (Cummings et al., 1994). Furthermore, general daily functioning will be assessed with the Groningen Activity Restriction Scale (GARS) (Kempen et al., 1996) and quality of life with Cantril’s ladder (Cantril, 1965). Secondary outcome measures are the change in the four separate cognitive domains (global cognitive functioning, executive functioning, (immediate and delayed) memory and psychomotor speed; the change in depressive symptoms and apathy as assessed with the NPI; physical functioning as assessed with the GARS, and quality of life according to Cantril’s ladder.