Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)
27 augusti 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
293
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ansan, Korea, Republiken av
- Korea University Medical College
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Bucheon, Korea, Republiken av, 420-767
- Soonchunhyang University Hospital
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Bucheon, Korea, Republiken av
- Bucheon St. Mary's Hospital, The Catholic University of Korea
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Busan, Korea, Republiken av
- Pusan National University Hospital
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Busan, Korea, Republiken av, 602-715
- DongA University Hospital
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Daejun, Korea, Republiken av, 302-799
- Daejun Eulji University Hopistal
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Goyang, Korea, Republiken av
- NHIC Ilsan Hospital
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Goyang, Korea, Republiken av, 412-270
- MyongJi Hospital
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Incheon, Korea, Republiken av, 400-711
- Inha Univeristy Hospital
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Jeju, Korea, Republiken av
- Jeju National University Hospital
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Pusan, Korea, Republiken av
- Maryknoll Hospital
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Seongnam, Korea, Republiken av
- bobath Memorial Hospital
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Seoul, Korea, Republiken av
- Inje University Sanggye Paik Hospital
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Seoul, Korea, Republiken av, 135-710
- Sungkyunkwan University, Samsung Seoul Hospital
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Seoul, Korea, Republiken av, 431-060
- Asan Medical Center, Psychiatry
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Seoul, Korea, Republiken av
- Konkuk University Medical Cener
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Suwon, Korea, Republiken av
- Ajou University Hospital
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Yongin, Korea, Republiken av
- Hyoja Geriatric Hospital
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-
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
50 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
|---|---|
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Aktiv komparator: 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.
|
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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Aktiv komparator: 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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Inget ingripande: Wait list Control
They will participate in cognitive intervention after ending this study.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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story recall test
Tidsram: 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
Tidsram: postintervention, 12 weeks follow-up, and 24 weeks follow-up
|
postintervention, 12 weeks follow-up, and 24 weeks follow-up
|
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Word fluency test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: postintervention, 12 weeks follow-up, and 24 weeks follow-up
|
postintervention, 12 weeks follow-up, and 24 weeks follow-up
|
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Mini-Mental State Examination
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Seong H Choi, MD, PhD, Inha University Hospital
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 mars 2011
Primärt slutförande (Faktisk)
1 januari 2013
Avslutad studie (Faktisk)
1 januari 2013
Studieregistreringsdatum
Först inskickad
20 maj 2011
Först inskickad som uppfyllde QC-kriterierna
20 maj 2011
Första postat (Uppskatta)
24 maj 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
28 augusti 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2013
Senast verifierad
1 augusti 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CogMCI study
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