Vascular Cognitive Impairment no Dementia Clinical Trial
Official title:
The Cog-VACCINE Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with subcortical VCIND. Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task.
Background:
Vascular cognitive impairment no dementia (VCIND) refers to cognitive deficits associated
with underlying vascular causes which fall short of a dementia diagnosis. Because of its high
prevalence and high progression to dementia, interest in VCIND has greatly expanded in recent
years. Although it has been widely recognized that early intervention of VCIND holds the
potential to delay or even reverse the cognitive impairment, no treatment is available yet.
Executive dysfunction is the characteristic impairment in subcortical VCIND, and cognitive
training significantly improved executive and other aspects of cognitive function in health
older adults and patients with cognitive impairment. Whether and how cognitive training
improves cognitive function in patients with VCIND remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether
internet-based cognitive training in patients with subcortical VCIND improves their cognitive
abilities. The second objective is to evaluate the effect of cognitive training on neural
plasticity, including brain activation and white matter integrity, which are assessed by
functional and structural MRI. Finally, possible genetic and plasma biomarkers related to a
positive effect or lack of effect of the training will be examined.
Patients and Methods:
The proposed study is a three-center, double-blinded, randomized controlled trial that will
include 60 patients diagnosed with VCIND from the neurology clinics at Beijing Friendship
hospital, Xuan Wu hospital, and geriatric clinic at Fu Xing hospital, Capital Medical
University. The patients will be randomized to either a training or a control group. The
intervention is internet-based cognitive training performed for 30 minutes over 35 sessions.
Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be
performed before and 7 weeks after training.
Relevance:
Currently there is no known treatment available for VCIND. The proposed study is to determine
the efficacy of cognitive training in patients with VCIND. Secondly, using functional and
structural MRI, this study is to reveal the potential mechanism underlying cognitive
training.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Phase 2/Phase 3 | |
| Completed |
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Phase 2 |