Clinical trial NCT03232047: Computerized Cognitive Training for MCI
Official title: A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Computerized, Executive function, memory, cognitive training
Mild Cognitive Impairment
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Composite working memory z score
timeFrame: Change from baseline composite working memory z score at week 26
Secondary outcomes:
measure: cognitive test package (CTP)
timeFrame: Changes from baseline composite CTP score at week 26
measure: Self evaluated memory ability
timeFrame: Change from baseline self evaluated memory ability at week 26
measure: Brain Functional Imaging
timeFrame: change from baseline functional connectivity at week 26
measure: Electrical activity of the brain
timeFrame: change from baseline electrical brain activity at week 26
measure: Brain structural imaging
timeFrame: change from baseline cortical thickness at week 26
measure: cerebral blood flow
timeFrame: change from baseline cerebral blood flow at week 26
measure: Mood
timeFrame: Change from baseline composite mood score at week 26
measure: BDNF level
timeFrame: change from baseline serum BDNF level at week 26
measure: Composite of overall cognition z scores
timeFrame: Changes from baseline composite overall cognition z score at week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Mental Health(Six Hospital)
state: Beijing
Study officials:
affiliation: Peking University Institute of Mental Health(Sixth hospital)
name: Huali Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.