Amnestic Mild Cognitive Impairment Clinical Trial
Official title:
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
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.
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.
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