A study on improving the diagnostic performance of mild cognitive impairment using Multi-PLD AS
- Conditions
- mild cognitive impairment
- Registration Number
- JPRN-jRCT1020210069
- Lead Sponsor
- Sasaki Makoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 190
For all participants:
1. Age between 55-85 years (inclusive) at the time of obraining consent or MRI scan.
2. MRI scan can be performed within one month from the time of obtaining consent.
3. The subject's free and voluntary consent to participate in the study has been obtained after receiving sufficient explanation and understanding.
4. Visual and auditory acuity adequate for neuropsychological testing.
5. Good general health with no diseases expected to interfere with the study.
6. Not pregnant, lactating, or of childbearing potential.
7. Mini-Mental State Exam score between 24 and 30 (inclusive).
8. Geriatric Depression Scale-15-J less than 6.
9. Modified Hachinski less than or equal to 4.
10. Not taking any medications that may affect the study.
Additional inclusion criteria for MCI subjects:
1. Awareness of memory problems, either by themselves or by others.
2. General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made.
3. Japanese version of the Montreal Cognitive Assessment score less than or equal to 25.
4. Wechsler Memory Scale-Revised Logical Memory II scores less than or equal to the cutoff by years of education:
a. <=11 for 16 or more years of education
b. <=9 for 10-15 years of education
c. <=6 for 0-9 years of education
Additional inclusion criteria for control subjects:
1. No complaints of memory loss beyond subjects age.
2. Normal cognition with no significant impairment of cognitive function or ADL.
3. Japanese version of the Montreal Cognitive Assessment score of 26 or above.
4. Wechsler Memory Scale-Revised Logical Memory II scores above the cutoff by years of education:
a. >=9 for 16 or more years of education
b. >=5 for 10-15 years of education
c. >=3 for 0-9 years of education
1. Organic central nervous system disorders, or neurological or psychiatric disorders.
2. Presence of pacemakers, deep brain stimulator or other contraindications to MRI.
3. Claustrophobia.
4. Screening MRI scan with evidence of infection, infarction, other focal lesions, or structural brain abnormalities. Participants with multiple lacunes or lacunes in a critical memory structure are also excluded.
5. Schizophrenia, major depression, bipolar disorder within the past 1 year, or history of alcohol or substance abuse or dependence within the past 2 years as described in DSM-IV.
6. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
7. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
8. Clinically significant abnormalities in B12, or TFTs that might interfere with the study.
9. Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
10. Other conditions in which the protocol director judges the subject to be inappropriate for the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method