Efficacy of Cognitive Training in Subjective Memory Impairment
6 août 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
65
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Seoul, Corée, République de
- Jae-Hong Lee
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
55 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Aucune intervention: No intervention
This group receives no intervention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Paired associates learning test
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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cognitive failure questionnaire
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jae-Hong Lee, MD,PhD, Asan Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2014
Achèvement primaire (Réel)
1 novembre 2015
Achèvement de l'étude (Réel)
1 février 2016
Dates d'inscription aux études
Première soumission
18 septembre 2015
Première soumission répondant aux critères de contrôle qualité
21 septembre 2015
Première publication (Estimation)
22 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 août 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 août 2018
Dernière vérification
1 août 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- YJeongHong
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