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Computerized Cognitive Training for MCI

19. marts 2019 opdateret af: Huali Wang, Peking University

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100191
        • Rekruttering
        • Peking University Institute of Mental Health(Six Hospital)
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Huali Wang, MD
        • Underforsker:
          • Haifeng Zhang, MS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Combined executive function and memory training
Computerized combined executive function and memory training
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite working memory z score
Tidsramme: Change from baseline composite working memory z score at week 26
composite score of digit span and spatial span
Change from baseline composite working memory z score at week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cognitive test package (CTP)
Tidsramme: Changes from baseline composite CTP score at week 26
composite score of episodic memory, speed processing, executive function, attention, language and social cognition
Changes from baseline composite CTP score at week 26
Self evaluated memory ability
Tidsramme: Change from baseline self evaluated memory ability at week 26
Score on the questionnaire probes worries about memory (MMQ-contentment).
Change from baseline self evaluated memory ability at week 26
Brain Functional Imaging
Tidsramme: change from baseline functional connectivity at week 26
Brain function measured with MRI.
change from baseline functional connectivity at week 26
Electrical activity of the brain
Tidsramme: change from baseline electrical brain activity at week 26
Brain activity measured with electroencephalography (EEG).
change from baseline electrical brain activity at week 26
Brain structural imaging
Tidsramme: change from baseline cortical thickness at week 26
cortical thickness measured with MRI
change from baseline cortical thickness at week 26
cerebral blood flow
Tidsramme: change from baseline cerebral blood flow at week 26
Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
change from baseline cerebral blood flow at week 26
Mood
Tidsramme: Change from baseline composite mood score at week 26
composite score of mood status
Change from baseline composite mood score at week 26
BDNF level
Tidsramme: change from baseline serum BDNF level at week 26
Serum Brain-derived neurotrophic factor (BDNF) level
change from baseline serum BDNF level at week 26
Composite of overall cognition z scores
Tidsramme: Changes from baseline composite overall cognition z score at week 26
Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
Changes from baseline composite overall cognition z score at week 26

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University

Efterforskere

  • Ledende efterforsker: Huali Wang, MD, Peking University Institute of Mental Health(Sixth hospital)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2017

Primær færdiggørelse (Forventet)

1. december 2019

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

22. juli 2017

Først indsendt, der opfyldte QC-kriterier

26. juli 2017

Først opslået (Faktiske)

27. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Z161100000516001

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Mild kognitiv svækkelse

Kliniske forsøg med Combined executive function and memory training

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