Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02098824
Status:
UNKNOWN
Last Update Posted:
2016-05-02
First Post:
2014-03-14
Brief Title:
Symptomatic Treatment of Vascular Cognitive Impairment
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Symptomatic Treatment of Vascular Cognitive Impairment
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STREAM-VCI
Brief 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
Detailed Description:
Vascular Cognitive Impairment is an important cause of cognitive impairment and dementia Till now there are no approved symptomatic treatments for Vascular Cognitive Impairment Research on novel pharmacological treatments that may reduce clinical symptoms in these patients is needed Evidence suggests that executive dysfunction and memory impairment in Vascular Cognitive Impairment are caused by damage to monoaminergic and cholinergic neurotransmitter-systems respectively
However patients with Vascular Cognitive Impairment form a clinically heterogeneous group ie the extent to which executive function and memory are affected differs from patient to patient Previous intervention studies have not taken this inter-patient variability into account Individually tailored pharmacological interventions aimed at the affected neurotransmitter systems may ameliorate cognitive symptoms in patients with Vascular Cognitive Impairment Using a pharmacological challenge it is possible to detect individual sensitivity to specific pharmacological interventions Furthermore with the use of novel MRI techniques it is possible to correlate the location and severity of cerebrovascular lesions to impaired structural and functional connectivity in each subject
The investigators will recruit 30 patients with Vascular Cognitive Impairment according to the criteria of the American Heart AssociationAmerican Stroke Association at the Alzheimer Center of the VU University Medical Center and the Utrecht University Medical Center They will also undergo MRI including diffusion tensor imaging MRI DTIfiber tracking and resting state RS functional MRI fMRI In a double-blind three-way case cross over trial the investigators will study the effects of methylphenidate on executive function and of galantamine on episodic memory function During three separate visits patients will receive the pharmacological interventions placebo methylphenidate and galantamine at the investigators Clinical Research Unit Also during a study day the investigators will collect blood samples at different timepoints
However patients with Vascular Cognitive Impairment form a clinically heterogeneous group ie the extent to which executive function and memory are affected differs from patient to patient Previous intervention studies have not taken this inter-patient variability into account Individually tailored pharmacological interventions aimed at the affected neurotransmitter systems may ameliorate cognitive symptoms in patients with Vascular Cognitive Impairment Using a pharmacological challenge it is possible to detect individual sensitivity to specific pharmacological interventions Furthermore with the use of novel MRI techniques it is possible to correlate the location and severity of cerebrovascular lesions to impaired structural and functional connectivity in each subject
The investigators will recruit 30 patients with Vascular Cognitive Impairment according to the criteria of the American Heart AssociationAmerican Stroke Association at the Alzheimer Center of the VU University Medical Center and the Utrecht University Medical Center They will also undergo MRI including diffusion tensor imaging MRI DTIfiber tracking and resting state RS functional MRI fMRI In a double-blind three-way case cross over trial the investigators will study the effects of methylphenidate on executive function and of galantamine on episodic memory function During three separate visits patients will receive the pharmacological interventions placebo methylphenidate and galantamine at the investigators Clinical Research Unit Also during a study day the investigators will collect blood samples at different timepoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None