CompletedPhase 3

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

Belarus, Kazakhstan, Russia503 participantsStarted 2012-06

Plain-language summary

The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in subjects with post stroke cognitive impairment (PSCI) during a six month treatment period compared to subjects administered placebo. Subjects received IV infusions whilst in hospital, and tablets once discharged. Subjects were followed up for a further six months after their treatment had been stopped to explore if the cognitive symptoms of the subjects treated with Actovegin showed sustained improvement. The trial also explored the possible prevention of dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was collected.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6

Timeframe: Baseline and Month 6

Trial details

NCT IDNCT01582854

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2016-01-23