Computerized Cognitive Training for MCI

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03232047
• Other study ID #: Z161100000516001
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: Peking University
• Contact: Huali Wang, MD
• Phone: +86-10-82801983
• Email: huali_wang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Combined executive function and memory training
Computerized combined executive function and memory training

Locations

Country	Name	City	State
China	Peking University Institute of Mental Health(Six Hospital)	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Self evaluated memory ability	Score on the questionnaire probes worries about memory (MMQ-contentment).	Change from baseline self evaluated memory ability at week 26
Secondary	Brain Functional Imaging	Brain function measured with MRI.	change from baseline functional connectivity at week 26
Secondary	Electrical activity of the brain	Brain activity measured with electroencephalography (EEG).	change from baseline electrical brain activity at week 26
Secondary	Brain structural imaging	cortical thickness measured with MRI	change from baseline cortical thickness at week 26
Secondary	cerebral blood flow	Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).	change from baseline cerebral blood flow at week 26
Secondary	Mood	composite score of mood status	Change from baseline composite mood score at week 26
Secondary	BDNF level	Serum Brain-derived neurotrophic factor (BDNF) level	change from baseline serum BDNF level at week 26
Secondary	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