Computerized Cognitive Training for MCI

Peking University

Status: Unknown

Conditions: Mild Cognitive Impairment

Treatments: Device: Combined executive function and memory training

Study type: Interventional

Funder types: Other

Identifiers

NCT03232047

Z161100000516001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score < 26)
2. Preserved general cognitive function( an mini-mental state examination (MMSE) score of > 24)
3. Clinical Dementia Rating (CDR) = 0.5
4. Hamilton Depression Scale (HAMD) score of < 12
5. Intact activities of daily living (ADL score of <=26)
6. Schooling education > = 5 years)
7. Not meeting the diagnosis of dementia (according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Probable Alzheimer's Criteria

Exclusion criteria

1. Serious visual or hearing impairment;
2. Hachinski Ischemia Scale (HIS) >= 4;
3. 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;
4. currently on titration of medications with cognitive enhancers or antidepressants;
5. having any physical condition that could preclude regular attendance and full intervention-program participation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Combined cognitive training

Experimental group

Description:

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.

Treatment:

Device: Combined executive function and memory training

Waiting-list group

No Intervention group

Description:

Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period. During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.