Home-based and group cognitive intervention programs in amnestic mild cognitive impairment
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0000328
- Lead Sponsor
- Inha University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 270
1.50 to 85 years of age
2.memory complaint corroborated by a participant and an informant
3.delayed recall score on the Seoul Verbal Learning Test (SVLT) at or below 1.5 standard deviations from the mean of the age and education-normative values among the Korean population
4. Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
5. at or 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
6. normal functional activities
7. Not diagnosed with dementia
8. Modified Hachinski Ischemic Score (HIS): 0-4
9. 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.
10. 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.
11. He/She can read and write
12. written infromed consent
1. any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
2. 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)
3. 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
4. any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
5. any patiens with any history of drug or alcohol addiction during the past 10 years
6. any hearing or visual impairment that can disturb the efficient evaluation of the patient
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-cog)
- Secondary Outcome Measures
Name Time Method story recall test ;Digit span forward & backward;Word fluency test ;Digit symbol test;color-word stroop test ;prospective memory test ;Korean Mini-Mental State Examination (K-MMSE) ;Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) ;Korean version of the Alzheimer disease 8 (K-AD8);Prospective and Retrospective Memory Questionnaire (PRMQ) ;Multifactorial Memory Questionnaire (MMQ)-Strategy ;Quality of life-Alzheimer’s disease (QOL-AD) ;Korean version of the Geriatric Depression Scale-short form (SGDS-K) ;Bayer Activities of Daily Living (ADL) ;Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) ;Subjective cognitive assessment