Symptomatic Treatment of Vascular Cognitive Impairment

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Single center threeway double blind cross over trial investigating the pharmacological responsivity in patients with VCI using a challenge aimed at the monoaminergic and cholinergic neuronal systems

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Galantamine; Methylphenidate

Criteria

Inclusion Criteria:

• Outpatients

• Objective executive dysfunction and/or memory impairment on neuropsychological tests and imaging evidence of cerebrovascular disease (white matter changes (Fazekas ≥2, (lacunar) infarcts)

• Mini Mental State Examination (MMSE) ≥16

• Clinical Dementia Rating Score (CDR of 0.5-1)

• No contraindication for treatment with a Cholinesterase inhibitor (CEI) or Methylphenidate (MPH) (www.fk.cvz.nl)

• Assessed by the treating neurologist as mentally capable of understanding the implications of study participation

• Presence of an informant/caregiver at the information visit, signing of informed consent, and all study visits

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 on the study day until the end of the study day

• Other causes that can explain cognitive symptoms including but not limited to:

delirium, multiple sclerosis, amyotrophic lateral sclerosis, progressive supranuclear palsy, mental retardation, infectious encephalitis that led to persistent cognitive deficits or head trauma with loss of consciousness that led to persistent cognitive deficits

• Use of neuroleptics

• Use of celiprolol or sotalol

• Use of MAO-A/B inhibitors

• Current use of centrally acting anticholinergics (e.g. oxybutynin, 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 patients are on a stable dose without any recent or upcoming changes

• 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