Symptomatic Treatment of Vascular Cognitive Impairment (STREAM-VCI)
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|ClinicalTrials.gov Identifier: NCT02098824|
Recruitment Status : Unknown
Verified April 2016 by Dr. Niels Prins, MD, PhD, VU University Medical Center.
Recruitment status was: Recruiting
First Posted : March 28, 2014
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment (Vascular) Mild Cognitive Disorder (Vascular) Vascular Dementia||Drug: Galantamine Drug: Methylphenidate Drug: Placebo||Phase 2 Phase 3|
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, i.e. 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 Association/American 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 (DTI)/'fiber 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Symptomatic Treatment of Vascular Cognitive Impairment|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||July 2017|
Active Comparator: Galantamine
Single administration of capsule containing 16 mg Galantamine
Single administration of capsule containing 16 mg of Galantamine
Other Name: Reminyl
Placebo Comparator: Placebo
Single oral administration of capsule containing placebo
Single administration of capsule containing placebo
Active Comparator: Methylphenidate
Single administration of capsule containing 10 mg Methylphenidate
Single administration of capsule containing 10 mg of Methylphenidate
Other Name: Ritalin
- Change on performance on executive function and on memory after active challenge [ Time Frame: timepoints 1 hour, 2.5 hours and 3.5 hours ]Patients will perform multiple Neurocart tests: eye movement recording, pharmaco-EEG's, visual verbal language test (VVLT), Adaptive Tracker, Facial Recognition taks, N-back and Stop Signal test of which the Adaptive Tracker and VVLT have the main focus.
- Change on performance on other Neurocart tests after active challenge [ Time Frame: Timepoints 1.0 hour, 2.5 hours and 3.5 hours ]Change of performance on the other tests: N-back, Facial recognition task, Stop Signal task, eye movements and pharmaco-EEG
- Locations and number of cerebrovascular lesions [ Time Frame: Single MRI scan after screening ]If patients are suitable for the study and have signed the informed consent they will undergo a MRI (structural, DTI and RS-fMRI). Visual assessment of structural cerebrovascular lesions in each patients
- Structural connectivity of white matter tracts [ Time Frame: Single MRI after screening ]If patients are suitable for the study and have signed the informed consent they will undergo a MRI (structural, DTI and RS-fMRI). Assessment of structural connectivity of specific white matter tracts, known to be part of the cholinergic and monoaminergic system with FLS software
- Functional connectivity in resting state networks [ Time Frame: Single MRI, after screening ]If patients are suitable for the study and have signed the informed consent they will undergo a MRI (structural, DTI and RS-fMRI). Assessment functional connectivity in specific resting state networks
- Maximum concentration (Cmax) [ Time Frame: t-1.5, t=1, t=2.5, t=3.5 ]
- Time of Cmax (Tmax) [ Time Frame: t=-1.5, t=1, t=2.5, t=3.5 ]
- Area under the Curve [ Time Frame: t=-1.5, t=1, t=2.5,t=3.5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098824
|Contact: Niels D Prins, MD,PhD||+20 firstname.lastname@example.org|
|Contact: Jolien F Leijenaar, MD, MScemail@example.com|
|VU University Medical Center||Recruiting|
|Amsterdam, Netherlands, 1081 HV|
|Contact: Niels D Prins, MD, PhD +20 3017170 firstname.lastname@example.org|
|Sub-Investigator: Jolien F Leijenaar, MD, MSc|
|Principal Investigator:||Niels D Prins, MD, PhD||VUmc|