memory complaints post-stroke cognitive impairment
Conditions
Interventions
Methylphenidate 10 mg
Galantamine 16 mg
Placebo
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Outpatients Objective executive dysfunction and/or memory impairment and imaging evidence of cerebrovascular disease (white matter changes (Fazekas=/>2, lacunar infarcts) MMSE =/>16 Clinical Dementia Rating Score (CDR of 0.5-1) No contraindication for treatment with a cholinesterase inhibitor or methylphenidate Assessed by the treating neurologist as mentally capable of understanding the implications of study participation Presence of an informant,/caregiver at the information visit and the signing of the informed consent Signed informed consent by patient
Exclusion criteria
Exclusion criteria: Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history taking and physical examinations obtained during the screening visit and/or at the study day as judged by the investigator; Clinically relevant abnormal laboratory results, electrocardiogram (ECG) and vital signs, or physical findings at screening and/or at the start of the study day (as judged by the investigator); Unwilling to or unable to stop smoking 12 hours before study day until 12 hours after the study day Other causes that can explain cognitive symptoms Use of doses of corticosteroids that in the opinion of the investigator may interfere pharmacodynamic measurements performed in the study. Use of celiprolol or sotalol Use of neuroleptics Current use of centrally acting anticholinergics (e.g. oxybutinin, mebeverine, ipratropium(bromide)) Use of benzodiazepine within 48 hours before a study day Current use of a CEI (rivastigmine, galantamine, donepezil) Alcohol abuse (defined as use of alcohol despite significant areas of dysfunction, evidence of physical dependence, and/or related hardship due to alcohol) Use of recreational drugs Concomitant use of inhibitors of CYP2D6 (a/o kinidine, paroxetine, fluoxetine) or of CYP3A4 (a/o ketoconazole, ritonavir) unless on a stable dose and no expected upcoming changes in dosing. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject. Any contra-indication for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the performance on the cognitive tests as measured with the neurocart. | — |
Secondary
| Measure | Time frame |
|---|---|
| DTI and RS fMRI parameters integrity on white matter tracts and neuronal networks | — |
Countries
Netherlands
Outcome results
None listed