Randomized, open-label, parallel-group study to assess the feasibility of patient selection, treatment regimen and outcome measures and to obtain preliminary data for sample size estimation for a trial to evaluate treatment effects on cognitive and emotional functioning of Ginkgo biloba extract EGb 761® in patients who had suffered an acute ischemic stroke

Dr Willmar Schwabe (Germany)0 sites201 target enrollmentDecember 3, 2020

ConditionsAcute ischemic stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Acute ischemic stroke
Sponsor: Dr Willmar Schwabe (Germany)
Enrollment: 201
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37063270/ (added 18/04/2023)

Registry

who.int

Start Date

December 3, 2020

End Date

June 14, 2018

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Dr Willmar Schwabe (Germany)

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patients aged 50 years or older. The patients will be enrolled while they are inpatients treated for acute ischemic stroke; study\-related treatment and procedures will be continued after discharge from the hospital, i.e. they will be treated as outpatients most of the time.
•2\. Written informed consent according to applicable law; patient must be mentally and physically capable of giving informed consent
•3\. Written informed consent from an informant to accompany the patient to the study visits and to provide the requested information (partner, close relative, close friend)
•4\. Clinical stroke at least 7 but no longer than 14 days before baseline
•5\. Score of 20 or lower on the NIHSS
•6\. MRI scan indicating acute ischemic cerebral infarction and no signs of haemorrhage/haematoma, tumor, normal pressure hydrocephalus or other serious cerebral disorder or abnormality; of note: lacunes, white matter hyperintensities and/or mild atrophy consistent with a pre\-dementia state of Alzheimer's disease or cerebrovascular disease are acceptable
•7\. Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological testing without the assistance of an interpreter
•8\. An informant (partner, close relative, close friend) is available and willing to accompany the patient to the clinical visits and to provide information about the patient's cognitive problems, functional activities and neuropsychiatric symptoms; this person should have regular personal contact with the patient (at least four times a week)

Exclusion Criteria

•1\. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment
•2\. Long\-term hospitalization (i.e. expected duration more than 6 weeks after screening or unpredictable duration) of the patient for treatment or nursing home placement for bedside care. (Please note: Assisted living facility residence or stay in a rehabilitation facility is acceptable if the patient is not bedridden and does not need general bedside nursing and if an informant is available who sees the patient on a regular basis and accompanies him/her to the study visits.)
•3\. Signs of intracranial haematoma, tumor, hydrocephalus or other findings indicating a serious brain disease or abnormality (except lacunes, white matter hyperintensities and/or slight atrophy consistent with pre\-dementia states of Alzheimer's disease or cerebrovascular disease)
•4\. Any type of dementia (e.g. dementia in Alzheimer's disease, vascular dementia) or other major neurological disorder (e.g. alcohol\-associated brain damage, HIV associated cognitive disorder, Parkinson’s disease, Huntington’s disease, Pick’s disease, Wilson’s disease, normal pressure hydrocephalus, progressive supra\-nuclear palsy, Creutzfeldt\-Jakob disease, infectious CNS disease, brain tumor, subdural hematoma, multiple sclerosis, seizure disorder, recent brain trauma, etc)
•4\.1\. The disease listed under this criterion (e.g. Alzheimer’s disease, Pick disease) are chronic diseases, i.e. if a patient has ever been diagnosed with one of these diseases, the disease must still be present when the patient is screened for the study. Exceptions are infectious brain disease, brain tumor, subdural hematoma and brain trauma.
•4\.2\. As infectious brain diseases and brain tumor surgery are likely to permanently damage brain structures, patients should be excluded, if they had suffered one of these conditions at any time before.
•4\.3\. Patients who had suffered a brain trauma or subdural hematoma within the last 6 months before screening should also be excluded. Brain trauma or subdural hematoma suffered more than 6 months before screening are acceptable, as long as there are no residual functional deficits of a type and severity that would require exclusion according to criterion No. 5\.
•5\. Aphasia, dysarthria, paresis of the dominant upper extremity, severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the patient from co\-operating adequately in the trial or that may interfere with neuropsychological test performance. The critical question is, whether any of these deficits is likely to interfere with neuropsychological test performance. Minor deficits may be acceptable, if they can be assumed not to influence test performance. For the Digit\-Symbol Substitution Test (DSST) and the Shape Trail Test (STT) the patient must be able to hold and move a pencil precisely and quickly, because both are timed tasks. For the Hopkins Verbal Learning Test (HVLT) and the Verbal Fluency Test (VFT) the patient is required to actively produce speech and to pronounce the words clearly enough to be understood.
•6\. Patients with major short\-term fluctuations of their condition (as judged by the investigator).
•7\. History of or current Major Depression, Generalized Anxiety Disorder, or other psychiatric disorder as defined by DSM\-IV/DSM\-5 criteria (If there was a single episode of such a psychiatric disorder before the stroke, the last epis