A study on improving the diagnostic performance of mild cognitive impairment using Multi-PLD ASL

JRCT ID: jRCT1020210069

Registered date:10/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: mild cognitive impairment
• Date of first enrollment: 10/02/2022
• Target sample size: 190
• Study type: Observational

Outcome(s)

• Primary Outcome: Comparison of diagnostic performance for MCI between Multi-PLD ASL and Single-PLD ASL using regional CBF values

Secondary Outcome

1. Comparison of diagnostic performance for MCI between Multi-PLD ASL and VBM
2. Comparison of whole brain and regional CBF values between Multi-PLD ASL and Single-PLD ASL
3. Correlation analysis between Multi-PLD ASL CBF and neuropsychological test scores

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Sasaki Makoto
• Source(s) of Monetary Support: FUJIFILM Healthcare Corporation