Efficacy of Cognitive Training in Subjective Memory Impairment
6. august 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
65
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken
- Jae-Hong Lee
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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
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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.
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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
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Ingen inngripen: No intervention
This group receives no intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Paired associates learning test
Tidsramme: 3 month
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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.
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3 month
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Rapid visual information processing test
Tidsramme: 3 month
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rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB.
The score is shown as correct response rate.%
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3 month
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Pattern recognition memory test
Tidsramme: 3 month
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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.%
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3 month
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Spatial working memory test
Tidsramme: 3 month
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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.
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3 month
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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cognitive failure questionnaire
Tidsramme: 3 month
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questionnaire for measuring self reported cognitive status.
score range: 0-100.
Higher score means worse cognitive status.
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3 month
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Mini-mental state examination
Tidsramme: 3 month
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mini-mental state examination that examines general cognition.
range 0-20.
Higher score means better cognition.
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3 month
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Geriatric depression scale
Tidsramme: 3 month
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questionnaire for depression measuring.
score range:0-15.
lower score means less depression.
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3 month
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Beck anxiety index
Tidsramme: 3 month
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questionnaire for self reporting anxiety measuring.
range:0-63.
low score means less anxiety.
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3 month
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Seoul instrumental activities of daily living
Tidsramme: 3 month
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scale for measuring activities of daily living limitation.
score range 0-45.
low score means better ability.
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3 month
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Rey complex figure copy test
Tidsramme: 3 month
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test for visuospatial function.
Participants should copy the complex figure.
score range: 0-36.
Higher score means better visuospatial function.
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3 month
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Digit symbol test
Tidsramme: 3 month
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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.
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3 month
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Seoul verbal learning test, immediate recall
Tidsramme: 3 month
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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
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3 month
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Seoul verbal learning test, delayed recall
Tidsramme: 3 month
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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
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3 month
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Seoul verbal learning test, delayed recall
Tidsramme: 3 month
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measuring tool for cued recall of verbal memory function.
score range: 0-24.
2. Higher score means better memory recognition function
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3 month
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Logical memory test, delayed recall
Tidsramme: 3 month
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logical memory test is a part of a neuropsychological test named Wechsler
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3 month
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jae-Hong Lee, MD,PhD, Asan Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2014
Primær fullføring (Faktiske)
1. november 2015
Studiet fullført (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først innsendt
18. september 2015
Først innsendt som oppfylte QC-kriteriene
21. september 2015
Først lagt ut (Anslag)
22. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- YJeongHong
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