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Computerized Cognitive Training for MCI

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Combined executive function and memory training
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Computerized, Executive function, memory, cognitive training, Mild Cognitive Impairment

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University Institute of Mental Health(Six Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Combined cognitive training

Waiting-list group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Composite working memory z score
composite score of digit span and spatial span

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2017
Last Updated
March 19, 2019
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT03232047
Brief Title
Computerized Cognitive Training for MCI
Official Title
A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Computerized, Executive function, memory, cognitive training, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined cognitive training
Arm Type
Experimental
Arm 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.
Arm Title
Waiting-list group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Combined executive function and memory training
Intervention Description
Computerized combined executive function and memory training
Primary Outcome Measure Information:
Title
Composite working memory z score
Description
composite score of digit span and spatial span
Time Frame
Change from baseline composite working memory z score at week 26
Secondary Outcome Measure Information:
Title
cognitive test package (CTP)
Description
composite score of episodic memory, speed processing, executive function, attention, language and social cognition
Time Frame
Changes from baseline composite CTP score at week 26
Title
Self evaluated memory ability
Description
Score on the questionnaire probes worries about memory (MMQ-contentment).
Time Frame
Change from baseline self evaluated memory ability at week 26
Title
Brain Functional Imaging
Description
Brain function measured with MRI.
Time Frame
change from baseline functional connectivity at week 26
Title
Electrical activity of the brain
Description
Brain activity measured with electroencephalography (EEG).
Time Frame
change from baseline electrical brain activity at week 26
Title
Brain structural imaging
Description
cortical thickness measured with MRI
Time Frame
change from baseline cortical thickness at week 26
Title
cerebral blood flow
Description
Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
Time Frame
change from baseline cerebral blood flow at week 26
Title
Mood
Description
composite score of mood status
Time Frame
Change from baseline composite mood score at week 26
Title
BDNF level
Description
Serum Brain-derived neurotrophic factor (BDNF) level
Time Frame
change from baseline serum BDNF level at week 26
Title
Composite of overall cognition z scores
Description
Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
Time Frame
Changes from baseline composite overall cognition z score at week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Intact activities of daily living (ADL score of <=26) Schooling education > = 5 years) 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: 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; having any physical condition that could preclude regular attendance and full intervention-program participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huali Wang, MD
Phone
+86-10-82801983
Email
huali_wang@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng Zhang, MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huali Wang, MD
Organizational Affiliation
Peking University Institute of Mental Health(Sixth hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Mental Health(Six Hospital)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Zhang, MS
Phone
86+18813185360
Email
zhfphd@gmail.com
First Name & Middle Initial & Last Name & Degree
Xiaozhen Lv, PhD
Phone
86+82801983
Email
lxz120300@163.com
First Name & Middle Initial & Last Name & Degree
Huali Wang, MD
First Name & Middle Initial & Last Name & Degree
Haifeng Zhang, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30386820
Citation
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.
Results Reference
derived

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Computerized Cognitive Training for MCI

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