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A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment

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What is being tested

Combined executive function and memory training

Device
Who is being recruted

Mental Disorders+1

+ Cognition Disorders

+ Neurocognitive Disorders

From 60 to 89 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: August 2017
See protocol details

Summary

Principal SponsorPeking University
Study ContactHuali Wang, MDMore contacts
Last updated: January 27, 2026
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Study start date: August 1, 2017

Actual date on which the first participant was enrolled.

Introduction: Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia, but are more pronounced than the cognitive decline associated with normal aging. The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these individuals seem to remain stable or return to normal over time, but more than half progress to dementia within 5 years. Thus, MCI represents a critical window of opportunity for intervening and altering the trajectory of both cognitive decline and loss of functional independence in older adults. Cognitive function apart from memory such as executive function is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis on the training of executive function. Objectives: The objective of the study is to evaluate whether memory training combined with executive training could lead to improved cognitive and noncognitive performance in patients with MCI. Furthermore, we will explore the neural correlates underlying the changed performances. Patients and Methods: The proposed study is a single blinded, randomized and controlled trial that will include 120 elderly patients with MCI from the memory clinic. The groups will be randomized to either intervention or waiting-list group. The intervention is computerized combined memory and executive function training performed for 60 minutes x 4 times/week over 26 weeks. A neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after the intervention. The structural and functional MRI, EEG and NIRS will be performed at baseline and week 26 after intervention for a sub-study on the effect of cognitive training on brain structure and function.

Official TitleA Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
NCT03232047
Principal SponsorPeking University
Study ContactHuali Wang, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersCognition DisordersNeurocognitive DisordersCognitive Dysfunction

Criteria

7 inclusion criteria required to participate
An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score < 26)

Preserved general cognitive function( an mini-mental state examination (MMSE) score of > 24)

Clinical Dementia Rating (CDR) = 0.5

Hamilton Depression Scale (HAMD) score of < 12

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5 exclusion criteria prevent from participating
Serious visual or hearing impairment;

Hachinski Ischemia Scale (HIS) >= 4;

Subjects with Axis I disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), any other neurological disorders that could affect cognitive function;

currently on titration of medications with cognitive enhancers or antidepressants;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The training is combined executive function and memory training. The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking University Institute of Mental Health(Six Hospital)

Beijing, ChinaOpen Peking University Institute of Mental Health(Six Hospital) in Google Maps
SuspendedOne Study Center