Identification of regional alteration pattern of blood brain barrier on MRI related to Alzheimer's disease

Not Applicable

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0004094
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Cognitively impaired amyloid-PET positive
Common criteria
-age range between 55-90
-positive deposition on the amyloid-PET scans
-have reliable informant
Sub-group criteira:
1)AD
-linical Dementia Raging = 0.5 or 1
-meets DSM-IV criteria for dementia
-meets NIA-AA 2011 criteria for probable dementia
2)Mild Cognitive Impairment (MCI) due to AD
-CDR = 0.5
-Does not meet DSM-IV criteria for dementia
-Meets NIA-AA 2011 criteria for MCI

2. Preclinical AD with amyloid-PET positive
Criteria
-age range between 55-90
-positive deposition on the amyloid-PET scans
-have reliable informant
-CDR = 0

3. Cognitively normal with amyloid-PET negative
Criteria
-negative for deposition on the amyloid-PET scans
-have reliable informant
-CDR = 0
Sub-group criteira:
1)Cognitively normal middle-aged group
-age range between 55-90
2)Cognitively normal young group
-age range between 20-54

4. Cognitively impaired due to non-AD pathology with amyloid-PET negative (Dementia, MCI)
Criteria
-age range between 55-90
-negative for deposition on the amyloid-PET scans
-have reliable informant
Sub-group criteria:
1)Dementia due to non-AD pathology
-CDR = 0.5 or 1
-Meets DSM-IV criteria for dementia
2)MCI due to non-AD pathology
-CDR = 0.5
-Does not meet DSM-IV criteria for dementia
-Meets NIA-AA 2011 criteria for MCI

Exclusion Criteria

Exclusion criteria for the above groups are as follows:
-Presence of major psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder, alcohol/substance abuse or dependence, delirium)
-Significant neurological or medical condition or comorbidities that could affect mental functioning
-Contraindications for MRI scan (e.g. pacemaker, claustrophobia)
-Illiteracy or serious hearing and/or vision difficulties that prevents completion of neuropsychological assessments
-Taking an investigational drug
-Current pregnancy, possibly pregnant or breastfeeding
-If there is a history of kidney disease or a decrease in renal function (eGFR<60mL/min/1.73m2) at the time of injection of the MR contrast agent.
-History of allergic reaction to the MR contrast agent or other medications.

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain regional BBB permeability index (Ki, Ktrans) on the high resolution DCE-MRI