Mild Cognitive Impairment Clinical Trial
Official title:
A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking University Institute of Mental Health(Six Hospital) | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
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 |
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