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

Sasaki Makoto0 sites190 target enrollmentFebruary 10, 2022

Overview

No summary available.

Registry

who.int

Start Date

February 10, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Sasaki Makoto

•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\.

•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.