NCT02098824

Symptomatic Treatment of Vascular Cognitive Impairment

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Mild Cognitive Impairment (Vascular)
• Mild Cognitive Disorder (Vascular)
• Vascular Dementia

Interventions

Type	Name	Description
DRUG	Galantamine	Single administration of capsule containing 16 mg of Galantamine
DRUG	Methylphenidate	Single administration of capsule containing 10 mg of Methylphenidate
DRUG	Placebo	Single administration of capsule containing placebo

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2014-03-28
• Last updated: 2016-05-02

Locations

1 site across 1 country: Netherlands