Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)
27 augustus 2013 bijgewerkt door: Chul Soo Kim, Inha University Hospital
A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
- There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
- There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
293
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ansan, Korea, republiek van
- Korea University Medical College
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Bucheon, Korea, republiek van, 420-767
- Soonchunhyang University Hospital
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Bucheon, Korea, republiek van
- Bucheon St. Mary's Hospital, The Catholic University of Korea
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Busan, Korea, republiek van
- Pusan National University Hospital
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Busan, Korea, republiek van, 602-715
- DongA University Hospital
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Daejun, Korea, republiek van, 302-799
- Daejun Eulji University Hopistal
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Goyang, Korea, republiek van
- NHIC Ilsan Hospital
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Goyang, Korea, republiek van, 412-270
- MyongJi Hospital
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Incheon, Korea, republiek van, 400-711
- Inha Univeristy Hospital
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Jeju, Korea, republiek van
- Jeju National University Hospital
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Pusan, Korea, republiek van
- Maryknoll Hospital
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Seongnam, Korea, republiek van
- bobath Memorial Hospital
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Seoul, Korea, republiek van
- Inje University Sanggye Paik Hospital
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Seoul, Korea, republiek van, 135-710
- Sungkyunkwan University, Samsung Seoul Hospital
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Seoul, Korea, republiek van, 431-060
- Asan Medical Center, Psychiatry
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Seoul, Korea, republiek van
- Konkuk University Medical Cener
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Suwon, Korea, republiek van
- Ajou University Hospital
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Yongin, Korea, republiek van
- Hyoja Geriatric Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 50 to 85 years of age
- memory complaint corroborated by a participant and an informant
- delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
- Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
- above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
- normal functional activities
- not diagnosed with dementia
- Modified Hachinski Ischemic Score (HIS): 0-4
- brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
- Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
- He/She can read and write
- written informed consent
Exclusion Criteria:
- any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
- any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
- any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
- any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
- any patients with any history of drug or alcohol addiction during the past 10 years
- any hearing or visual impairment that can disturb the efficient evaluation of the patient
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Group cognitive intervention
The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics.
Each session will last approximately 90 minutes.
The cognitive training programs will be offered in group sessions consisted of 5 participants.
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The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics.
Each session will last approximately 90 minutes.
The cognitive training programs will be offered in group sessions consisted of 5 participants.
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Actieve vergelijker: Home-based cognitive intervention
The participants will do their homework for 30 minutes every business days for 12 weeks.
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The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
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Geen tussenkomst: Wait list Control
They will participate in cognitive intervention after ending this study.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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story recall test
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Digit span forward and backward
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Word fluency test
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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color-word stroop test
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Digit symbol test
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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prospective memory test
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Mini-Mental State Examination
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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CDR-SB
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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K-AD8
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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PRMQ
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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MMQ-Strategy
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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QOL-AD
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Geriatric Depression Scale-short form
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Bayer ADL
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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CGA-NPI
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Subjective cognitive assessment
Tijdsspanne: postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Seong H Choi, MD, PhD, Inha University Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2011
Primaire voltooiing (Werkelijk)
1 januari 2013
Studie voltooiing (Werkelijk)
1 januari 2013
Studieregistratiedata
Eerst ingediend
20 mei 2011
Eerst ingediend dat voldeed aan de QC-criteria
20 mei 2011
Eerst geplaatst (Schatting)
24 mei 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
28 augustus 2013
Laatste update ingediend die voldeed aan QC-criteria
27 augustus 2013
Laatst geverifieerd
1 augustus 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CogMCI study
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