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Efficacy of Cognitive Training in Subjective Memory Impairment

6 augusti 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

65

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

55 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Beteende: 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.
Beteende: 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
Inget ingripande: No intervention
This group receives no intervention.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Paired associates learning test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
cognitive failure questionnaire
Tidsram: 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
Tidsram: 3 month
mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.
3 month
Geriatric depression scale
Tidsram: 3 month
questionnaire for depression measuring. score range:0-15. lower score means less depression.
3 month
Beck anxiety index
Tidsram: 3 month
questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.
3 month
Seoul instrumental activities of daily living
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 month
logical memory test is a part of a neuropsychological test named Wechsler
3 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Asan Medical Center

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2014

Primärt slutförande (Faktisk)

1 november 2015

Avslutad studie (Faktisk)

1 februari 2016

Studieregistreringsdatum

Först inskickad

18 september 2015

Först inskickad som uppfyllde QC-kriterierna

21 september 2015

Första postat (Uppskatta)

22 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • YJeongHong

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