NCT03133052

CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI)

The CTA-MCI Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Control Training on Episodic Memory Function in Patients With Amnestic Mild Cognitive Impairment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and mechanism of internet-based cognitive control training on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half of participants will receive adaptive internet-based cognitive control training program, while the other half will receive a fixed, primary difficulty level task.

Detailed description

Background: Alzheimer's disease (AD) is a common dementia in elderly populations, and amnestic mild cognitive impairment (aMCI) refers to a transitional stage between normal aging and early dementia. Patients with aMCI are at higher risks of evolving toward AD. Although it has been widely recognized that early intervention of aMCI holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Episodic memory dysfunction is the characteristic impairment in aMCI, cognitive control training significantly improved executive function in patients with aMCI . Whether and how cognitive control training improves episodic memory function in patients with aMCI remains largely unknown. Objectives: The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive control training in patients with amnestic Mild Cognitive Impairment improves their episodic memory function. The second objective is to evaluate the effect of cognitive control training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI. Patients and Methods: The proposed study is a single-center, double-blinded, randomized controlled trial that will include 70 patients diagnosed with aMCI from the neurology clinics at The First Affiliated Hospital, Zhejiang University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive control training performed for 30 minutes over 60 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 12 weeks after training. Relevance: Currently there is no known treatment available for aMCI. The proposed study is to determine the efficacy of cognitive control training on episodic memory function in patients with aMCI. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive control training.

Conditions

• Amnestic Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	internet-based adaptive cognitive control training program	The cognitive training will be an internet-based adaptive cognitive control training program, specific training paradigms include Flanker, 1-back, 2-back. To maintain task difficulty, the tasks will be grouped based on the task difficulty. Furthermore, each task will have various difficulty levels.
BEHAVIORAL	placebo program	For the control group, a fixed, primary difficulty level program for all participants is set.

Timeline

• Start date: 2017-07-09
• Primary completion: 2019-11-01
• Completion: 2020-04-01
• First posted: 2017-04-28
• Last updated: 2019-02-19

Locations

1 site across 1 country: China