Computerized Cognitive Training for MCI
A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Beijing
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Beijing, Beijing, Čína, 100191
- Nábor
- Peking University Institute of Mental Health(Six Hospital)
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Kontakt:
- Haifeng Zhang, MS
- Telefonní číslo: 86+18813185360
- E-mail: zhfphd@gmail.com
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Kontakt:
- Xiaozhen Lv, PhD
- Telefonní číslo: 86+82801983
- E-mail: lxz120300@163.com
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Vrchní vyšetřovatel:
- Huali Wang, MD
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Dílčí vyšetřovatel:
- Haifeng Zhang, MS
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score < 26)
- Preserved general cognitive function( an mini-mental state examination (MMSE) score of > 24)
- Clinical Dementia Rating (CDR) = 0.5
- Hamilton Depression Scale (HAMD) score of < 12
- Intact activities of daily living (ADL score of <=26)
- Schooling education > = 5 years)
- 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:
- Serious visual or hearing impairment;
- Hachinski Ischemia Scale (HIS) >= 4;
- 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;
- currently on titration of medications with cognitive enhancers or antidepressants;
- having any physical condition that could preclude regular attendance and full intervention-program participation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Combined cognitive training
The training is combined executive function and memory training.
The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.
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Computerized combined executive function and memory training
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Žádný zásah: Waiting-list group
Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period.
During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Composite working memory z score
Časové okno: Change from baseline composite working memory z score at week 26
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composite score of digit span and spatial span
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Change from baseline composite working memory z score at week 26
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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cognitive test package (CTP)
Časové okno: Changes from baseline composite CTP score at week 26
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composite score of episodic memory, speed processing, executive function, attention, language and social cognition
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Changes from baseline composite CTP score at week 26
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Self evaluated memory ability
Časové okno: Change from baseline self evaluated memory ability at week 26
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Score on the questionnaire probes worries about memory (MMQ-contentment).
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Change from baseline self evaluated memory ability at week 26
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Brain Functional Imaging
Časové okno: change from baseline functional connectivity at week 26
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Brain function measured with MRI.
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change from baseline functional connectivity at week 26
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Electrical activity of the brain
Časové okno: change from baseline electrical brain activity at week 26
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Brain activity measured with electroencephalography (EEG).
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change from baseline electrical brain activity at week 26
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Brain structural imaging
Časové okno: change from baseline cortical thickness at week 26
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cortical thickness measured with MRI
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change from baseline cortical thickness at week 26
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cerebral blood flow
Časové okno: change from baseline cerebral blood flow at week 26
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Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
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change from baseline cerebral blood flow at week 26
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Mood
Časové okno: Change from baseline composite mood score at week 26
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composite score of mood status
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Change from baseline composite mood score at week 26
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BDNF level
Časové okno: change from baseline serum BDNF level at week 26
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Serum Brain-derived neurotrophic factor (BDNF) level
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change from baseline serum BDNF level at week 26
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Composite of overall cognition z scores
Časové okno: Changes from baseline composite overall cognition z score at week 26
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Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
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Changes from baseline composite overall cognition z score at week 26
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Huali Wang, MD, Peking University Institute of Mental Health(Sixth hospital)
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Z161100000516001
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