Symptomatic treatment of vascular cognitive impairment - STREAM-VCI

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 1, 2017

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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

•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)