NCT02640716

Cog-VACCINE: Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia

The Cog-VACCINE Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vascular Cognitive Impairment no Dementia

Interventions

Type	Name	Description
BEHAVIORAL	multi-domain internet-based adaptive training program	The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
BEHAVIORAL	placebo program	For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-05-08
• Completion: 2017-12-01
• First posted: 2015-12-29
• Last updated: 2020-07-23
• Results posted: 2020-07-23

Locations

1 site across 1 country: China