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Efficacy of Cognitive Training in Subjective Memory Impairment

6. august 2018 opdateret af: Jae-Hong Lee, Asan Medical Center

A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment

This study evaluates the efficacy of cognitive training in subjects with subjective memory impairment. The first group will receive cognitive training and lifestyle modification in combination, the second group will receive only lifestyle modification, and the third group will receive no intervention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjective memory impairment is currently thought to be a risky state of progression to Alzheimer's disease. This study aims to confirm whether cognitive training in subjective memory impairment would show improvement in the subjective and objective cognition. We include subjects with normal cognition but complained subjective feeling of memory decline and conduct cognitive training programs combined with lifestyle modifications for 3 months. We evaluate the neuropsychological tests and questionnaires about subjective improvement after 3 months of interventions.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

55 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who showed normal range (above 16percentile of norm) in all domains of detailed neuropsychological tests battery named Seoul Neuropsychological Screening Battery (SNSB)
  • Clinical dementia rating (CDR) score of 0
  • Subjects with at least 3 years of formal education

Exclusion Criteria:

  • Subjects with mild cognitive impairment or dementia
  • Subjects who was diagnosed as any neurological disorders such as epilepsy, stroke, hemorrhage, hydrocephalus, Parkinson's disease or brain tumor
  • Subjects with uncontrolled severe medical conditions according to investigator's opinion

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: cognitive training
Cognitive training programs 2 times a week for 3 months (totally 24 sessions) for 90 minutes per session. Lifestyle modification is educated first, then weekly phone call for lifestyle modification is done by investigators.
Adfærdsmæssigt: cognitive training
cognitive training is held 2 times a week for 3 months, 90 minutes per 1 session. It includes cognitive exercise of multiple cognitive domains such as memory, attention, calculation, executive function and visuospatial function.
Adfærdsmæssigt: lifestyle modification
education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications
Aktiv komparator: lifestyle modification
This group receives only lifestyle modification for 3 months. Lifestyle modification is educated at the first, then weekly phone call for lifestyle modification is done by investigators. The method of lifestyle modification is same with the first arm.
Adfærdsmæssigt: lifestyle modification
education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications
Ingen indgriben: No intervention
This group receives no intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Paired associates learning test
Tidsramme: 3 month
paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors.
3 month
Rapid visual information processing test
Tidsramme: 3 month
rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB. The score is shown as correct response rate.%
3 month
Pattern recognition memory test
Tidsramme: 3 month
paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The score is shown as correct response rate.%
3 month
Spatial working memory test
Tidsramme: 3 month
paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors.
3 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cognitive failure questionnaire
Tidsramme: 3 month
questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status.
3 month
Mini-mental state examination
Tidsramme: 3 month
mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.
3 month
Geriatric depression scale
Tidsramme: 3 month
questionnaire for depression measuring. score range:0-15. lower score means less depression.
3 month
Beck anxiety index
Tidsramme: 3 month
questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.
3 month
Seoul instrumental activities of daily living
Tidsramme: 3 month
scale for measuring activities of daily living limitation. score range 0-45. low score means better ability.
3 month
Rey complex figure copy test
Tidsramme: 3 month
test for visuospatial function. Participants should copy the complex figure. score range: 0-36. Higher score means better visuospatial function.
3 month
Digit symbol test
Tidsramme: 3 month
a test for attention and psychomotor speed. Participants are instructed to write an appropriately matched code for each number. Correct number is counted. score range: 0-76. Higher score means better function.
3 month
Seoul verbal learning test, immediate recall
Tidsramme: 3 month
measuring tool for immediate memory function. Investigators read 12 words to participants. Participants should remember the words. Tests are done 3 times. score range: 0-36. Higher score means better immediate memory function
3 month
Seoul verbal learning test, delayed recall
Tidsramme: 3 month
measuring tool for 20 minutes delayed memory function. After 20 minutes from the immediate recall test, participants should remember the words. score range: 0-12. Higher score means better delayed memory function
3 month
Seoul verbal learning test, delayed recall
Tidsramme: 3 month
measuring tool for cued recall of verbal memory function. score range: 0-24. 2. Higher score means better memory recognition function
3 month
Logical memory test, delayed recall
Tidsramme: 3 month
logical memory test is a part of a neuropsychological test named Wechsler
3 month

Samarbejdspartnere og efterforskere

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

Sponsor

Asan Medical Center

Efterforskere

  • Ledende efterforsker: Jae-Hong Lee, MD,PhD, Asan Medical Center

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

1. maj 2014

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

18. september 2015

Først indsendt, der opfyldte QC-kriterier

21. september 2015

Først opslået (Skøn)

22. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YJeongHong

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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