Multimodal Biomarkers for Diagnosis and Prognosis in CAA

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

By combination of plasma (Aβ40, Aβ42, total tau, and phosphorylated tau, etc.), genetic (ApoE ε2 or ε4 allele), MRI (cerebral perfusion, microbleeds, cortical superficial siderosis, enlarged perivascular space, etc.) and PET imaging (amyloid and tau) biomarkers, the study aims to

1. Enhance the diagnostic potentials of the radiological biomarkers by combining MRI and amyloid PET in CAA patients.

2. Investigate the biological pathogenesis in CAA patients using the less invasive plasma biomarkers and to correlate with structural and function imaging, including MRI, amyloid and tau imaging.

3. Study the characteristics of long-term progression of amyloid deposition in CAA patients using the radiological, biochemical and genetic biomarkers.

4. Study the prognosis predicting markers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Taiwan University Hospital

Criteria

Inclusion Criteria:

• ICH：

1. Age：above 20 years old.

2. Evidence of intraparenchymal hemorrhage on CT or MRI.

3. Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.

• AD：

1. Age：above 20 years old.

2. Patients who fulfills the clinical criteria of possible or probable Alzheimer's disease (AD).51

3. Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.

• Control：

1. Age：above 20 years old.

2. Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.

Exclusion Criteria:

• ICH：

1. patients with potential causes of hemorrhage including trauma, structural lesion, brain tumor, or coagulopathy due to systemic disease or medication.

2. Patients could not receive the PET and MRI studies, including but not limited to poor cooperative agitation impeding adequate study, allergy to contrast medium, hemodynamic instability, implantation of cardiac pacemaker, past history of receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.

3. Patients with pregnancy or recently having a plan for pregnancy.

4. Patients with breast feeding or recently having a plan for breast feeding.

5. Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy history.

6. Patient or family who does not agree to participate in the study.

7. patient with high risk by doctor evaluate.

• AD：

1. Patients could not receive the PET and MRI studies, including but not limited to poor cooperative agitation impeding adequate study, allergy to contrast medium, hemodynamic instability, implantation of cardiac pacemaker, past history of receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.

2. Patients with pregnancy or recently having a plan for pregnancy.

3. Patients with breast feeding or recently having a plan for breast feeding.

4. Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy history.

5. Patient or family who does not agree to participate in the study.

6. patient with high risk by doctor evaluate.

• Control：

1. History of neurological or psychiatric disease, abnormal neurological examination.

2. Patients could not receive the PET and MRI studies, including but not limited to poor cooperative agitation impeding adequate study, allergy to contrast medium, hemodynamic instability, implantation of cardiac pacemaker, past history of receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.

3. Patients with pregnancy or recently having a plan for pregnancy.

4. Patients with breast feeding or recently having a plan for breast feeding.

5. Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy history.

6. Patient or family who does not agree to participate in the study.

7. patient with high risk by doctor evaluate.