Symptomatic treatment of vascular cognitive impairment

Phase 2

Completed

• Conditions: memory complaints; 10029305; post-stroke cognitive impairment

• Registration Number: NL-OMON44729
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-09-01
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in the performance on the cognitive tests as measured with the<br /><br>neurocart. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>DTI and RS fMRI parameters integrity on white matter tracts and neuronal<br /><br>networks</p><br>