Computerized Cognitive Training for MCI

N/AUnknownNCT03232047

Peking University120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Mild Cognitive Impairment

Interventions

Combined executive function and memory trainingDEVICE

Computerized combined executive function and memory training

Eligibility

Sex: ALLMin age: 60 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University Institute of Mental Health(Six Hospital)

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Composite working memory z score

composite score of digit span and spatial span

Time frame: Change from baseline composite working memory z score at week 26

Secondary Outcomes

cognitive test package (CTP)

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

Self evaluated memory ability

Score on the questionnaire probes worries about memory (MMQ-contentment).

Time frame: Change from baseline self evaluated memory ability at week 26

Brain Functional Imaging

Brain function measured with MRI.

Time frame: change from baseline functional connectivity at week 26

Electrical activity of the brain

Brain activity measured with electroencephalography (EEG).

Time frame: change from baseline electrical brain activity at week 26

Brain structural imaging

cortical thickness measured with MRI

Time frame: change from baseline cortical thickness at week 26

cerebral blood flow

Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).

Time frame: change from baseline cerebral blood flow at week 26

Mood

composite score of mood status

Central Contacts

Huali Wang, MD

CONTACT

+86-10-82801983 huali_wang@bjmu.edu.cn

Haifeng Zhang, MS

CONTACT

Data from ClinicalTrials.gov

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