Mild Cognitive Impairment
Conditions
Keywords
Computerized, Executive function, memory, cognitive training, Mild Cognitive Impairment
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.
Interventions
DEVICECombined executive function and memory training
Computerized combined executive function and memory training
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite working memory z score | Change from baseline composite working memory z score at week 26 | composite score of digit span and spatial span |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self evaluated memory ability | Change from baseline self evaluated memory ability at week 26 | Score on the questionnaire probes worries about memory (MMQ-contentment). |
| Brain Functional Imaging | change from baseline functional connectivity at week 26 | Brain function measured with MRI. |
| Electrical activity of the brain | change from baseline electrical brain activity at week 26 | Brain activity measured with electroencephalography (EEG). |
| Brain structural imaging | change from baseline cortical thickness at week 26 | cortical thickness measured with MRI |
| cognitive test package (CTP) | Changes from baseline composite CTP score at week 26 | composite score of episodic memory, speed processing, executive function, attention, language and social cognition |
| Mood | Change from baseline composite mood score at week 26 | composite score of mood status |
| BDNF level | change from baseline serum BDNF level at week 26 | Serum Brain-derived neurotrophic factor (BDNF) level |
| Composite of overall cognition z scores | Changes from baseline composite overall cognition z score at week 26 | Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE). |
| cerebral blood flow | change from baseline cerebral blood flow at week 26 | Cerebral blood flow measured with Near-infrared spectroscopy (NIRS). |
Countries
China
Contacts
Primary ContactHuali Wang, MD
Backup ContactHaifeng Zhang, MS
Outcome results
None listed