Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI) "ARTEMIDA"

Completed

Phase 3 Results

Eligibility Criteria

Main

Inclusion Criteria

- Participant has suffered a recent supra-tentorial ischaemic stroke supported by computed tomography (CT) scan or magnetic resonance imaging (MRI) findings (in accordance with local practice).
- Participant is male or female, aged 60 years or above.
- Participant has a score on the National Institute of Health Stroke Scale (NIHSS) between 3 and 18 (inclusive).
- Participant is capable of completing the Montreal Cognitive Assessment (MoCA) and has a score of ≤ 25 points with adjustment for level of education (4-9 school years ≤ 23 points, 10-12 years ≤ 24 points, >12 years ≤ 25 points).
Main

Exclusion Criteria

- Participant has a medical history of dementia.
- Participant has a known medical history of major depression or psychotic disorder.
- Participant is indicated for treatment with thrombolytics or carotid surgery as the current standard of care.
Randomisation Criteria:
- Inclusion Criteria.
- Ability to perform Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+).
- Exclusion Criteria.
- Clinically there is suspicion of progressive stroke.