Apathy Evaluation as New outcome After Stroke (AENEAS)

Apathy occurs in 20-25% of the patients after stroke and major or minor
depression in 20-72%. Apathy and depression are related but different
constructs and patients can be apathetic without being depressed. Cognitive
impairment after stroke occurs in 23-55% of the patients and both post-stroke
apathy and post-stroke depression are associated with cognitive impairment.
Depression negatively influences rehabilitation after stroke and is associated
with worse functional recovery and more impairment in activities of daily
living. Several studies suggested that apathy is negatively correlated with
functional recovery after stroke, and some suggested that this negative
association is stronger than for depression.

In spite of the frequent occurrence of these post-stroke neuropsychiatric
symptoms they are rarely used as endpoint in stroke trials. Most clinical
trials evaluating the efficacy of a new treatment in acute stroke use a scale
heavily relying on motor function. Affective and cognitive outcomes are rarely
taken into account. Important and clinically relevant treatment effects of new
interventions beyond motor-scores can easily be overlooked. This could lead to
discarding new treatments as *ineffective*, ignoring important treatment
effects on neuropsychiatric symptoms that can impair functional recovery and
quality of life.

We hypothesize that treatments in acute stroke to improve outcome can have
clinically relevant effects on apathy, depression and cognitive impairment and
that these effects can influence functional recovery independent of motor
outcome. We also hypothesize that especially in subjects with *good* motor
outcome, usually defined as mRS 0-1 or 0-2, post-stroke apathy can
significantly contribute to limitation in functional recovery beyond motor
deficit

a. To introduce apathy and related neuropsychiatric symptoms of depression and
cognitive impairment as new outcome parameters in acute stroke trials, and
study their impact on functional recovery.

b. To study if two new treatments, evaluated in ongoing acute stroke trials,
reduce the incidence of apathy, depression and cognitive impairment and improve
functional recovery independent of motor symptoms.

The study is an observational study in the framework of two ongoing clinical
trials. Patients will be recruited after the initial clinical trials in which
they were included (ARTIS and PASS) have finished. No interventions are done.
The study involves administration of several questionnaires and a short
neuropsychological battery twice, with an interval of six months.

There are no risks involved in administering several questionnaires and a short
neuropsychological battery. There are no direct benefits for the individual
participants. The burden for participants consists of two visits to the AMC, 6
months apart, where during 30-40 minutes questionnaires on mood, behaviour and
cognition will be administered.