Computerized Cognitive Training for MCI

NCT ID: NCT03232047

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-31

Brief Summary

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.

Detailed 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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Combined cognitive training

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.

Group Type: EXPERIMENTAL

Combined executive function and memory training

Intervention Type: DEVICE

Computerized combined executive function and memory training

Waiting-list group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Combined executive function and memory training

Computerized combined executive function and memory training

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Huali Wang

Director of Clinical Research Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huali Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Mental Health(Sixth hospital)

Locations

Peking University Institute of Mental Health(Six Hospital)

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huali Wang, MD

Role: CONTACT

huali_wang@bjmu.edu.cn

+86-10-82801983

Haifeng Zhang, MS

Role: CONTACT

Facility Contacts

Haifeng Zhang, MS

Role: primary

zhfphd@gmail.com

86+18813185360

Xiaozhen Lv, PhD

Role: backup

lxz120300@163.com

86+82801983

References

Zhang H, Wang J, Sun T, Wang Z, Lyu X, Yu X, Wang H. A randomized controlled trial of combined executive function and memory training on the cognitive and noncognitive function of individuals with mild cognitive impairment: Study rationale and protocol design. Alzheimers Dement (N Y). 2018 Oct 15;4:556-564. doi: 10.1016/j.trci.2018.09.004. eCollection 2018.

Reference Type: DERIVED

PMID: 30386820 (View on PubMed)

Other Identifiers

Z161100000516001

Identifier Type: -

Identifier Source: org_study_id