Discontinuation of ANtihypertensive Treatment in Older people with dementia living in a Nursing home

Neuropsychiatric symptoms (NPS) are very common in people with dementia and
severely affect quality of life and general daily functioning and hamper
optimal care. They are a burden for carers and a main reason for
institutionalisation. Recent studies found that hypoperfusion of the brain,
hypothesised to be a result of impaired autoregulation, is related to NPS.
Since antihypertensive treatment is associated with hypoperfusion of specific
brain areas, increasing the blood pressure by discontinuing antihypertensive
treatment is a promising treatment option for NPS, especially since 50% of the
nursing home residents with dementia use antihypertensive treatment.

To assess whether discontinuation of antihypertensive treatment in nursing home
residents with dementia
a) reduces NPS and improves quality of life;
b) improves general daily functioning and cognitive functioning;
c) reduces psychotropic medication use, falls, care dependency and caregiver
burden;
and
d) is safe regarding cardiovascular events.

Study design: Randomized open-label, single-blind controlled clinical trial.

Randomization to discontinuation (n=246) or continuation (n=246) of
antihypertensive treatment during 8 months. Discontinuation of antihypertensive
treatment aims to achieve a systolic blood pressure increase of 20 mmHg using a
drug-specific discontinuation algorithm.

Assessments of NPS with the NPI-NH, quality of life, dementia severity,
cognitive functioning, care dependency and general daily functioning will be
done at the nursing home both at baseline and at 4 and 8 months. Most
questionnaires will be filled out by professional and informal caregivers of
the patients to get information by proxy.

Patients in both study arms will continue to receive blood pressure
measurements during follow-up after a stable blood pressure has been reached.
This will be done for safety reasons in the intervention arm and to make both
study arms as similar as possible also in the control arm. Patients in the
intervention arm will be put on their original antihypertensive medication when
diastolic blood pressure exceeds 120 mmHg or systolic blood pressure exceeds
200 mmHg (180 mmHg for participants with diabetes mellitus or those who had had
a cardiovascular event >12 months ago) or an increase in systolic blood
pressure of 60 mmHg or greater relative to baseline. Moreover, all
cardiovascular events during the study will be closely monitored to prevent an
increase in cardiovascular events in the intervention group. A Data Safety and
Monitoring Board (DSMB) will be installed for monitoring of the safety data
(cardiovascular events).

This study will not interfere with standard care, diagnostics and treatment
(other than antihypertensive treatment) for patients with dementia.

Given the future rise in the number of older people with dementia and NPS in
our society, the impact of this trial will be substantial when this trial
demonstrates that NPS can be alleviated and quality of life can be improved by
discontinuation of antihypertensive treatment. Since NPS hamper optimal care
and are a serious burden for caregivers, this study will not only have an
impact on dementia patients, but also on caregivers and nursing staff.