Computerized Cognitive Training for MCI

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

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Combined executive function and memory training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huali Wang, MD; Phone Number: +86-10-82801983; Email: huali_wang@bjmu.edu.cn
• Study Contact Backup: Name: Haifeng Zhang, MS

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Institute of Mental Health(Six Hospital)
      • Contact: Haifeng Zhang, MS; Phone Number: 86+18813185360; Email: zhfphd@gmail.com
      • Contact: Xiaozhen Lv, PhD; Phone Number: 86+82801983; Email: lxz120300@163.com
      • Principal Investigator: Huali Wang, MD
      • Sub-Investigator: Haifeng Zhang, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Combined executive function and memory training; Computerized combined executive function and memory training
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite working memory z score	composite score of digit span and spatial span	Change from baseline composite working memory z score at week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive test package (CTP)	composite score of episodic memory, speed processing, executive function, attention, language and social cognition	Changes from baseline composite CTP score at week 26
Self evaluated memory ability	Score on the questionnaire probes worries about memory (MMQ-contentment).	Change from baseline self evaluated memory ability at week 26
Brain Functional Imaging	Brain function measured with MRI.	change from baseline functional connectivity at week 26
Electrical activity of the brain	Brain activity measured with electroencephalography (EEG).	change from baseline electrical brain activity at week 26
Brain structural imaging	cortical thickness measured with MRI	change from baseline cortical thickness at week 26
cerebral blood flow	Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).	change from baseline cerebral blood flow at week 26
Mood	composite score of mood status	Change from baseline composite mood score at week 26
BDNF level	Serum Brain-derived neurotrophic factor (BDNF) level	change from baseline serum BDNF level at week 26
Composite of overall cognition z scores	Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).	Changes from baseline composite overall cognition z score at week 26

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Huali Wang, MD, Peking University Institute of Mental Health(Sixth hospital)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 22, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Computerized, Executive function, memory, cognitive training
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Z161100000516001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No