Multimodal Biomarkers for Diagnosis and Prognosis in CAA

NCT03969732 | Unknown Phase 3

• 1 other identifier: 201612094MINB
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 1.Enhance the diagnostic potentials of the radiological biomarkers by combining MRI and amyloid PET in CAA patients.
2. 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. 3.Study the characteristics of long-term progression of amyloid deposition in CAA patients using the radiological, biochemical and genetic biomarkers.
4. 4.Study the prognosis predicting markers.

Conditions

Cerebral Amyloid Angiopathy; Intracranial Hemorrhages; Alzheimer Disease

Keywords

Stroke; intracerebral hemorrhage; cerebral amyloid angiopathy; amyloid PET; tau PET; MRI; Aβ; ApoE

Outcome Measures

Primary Outcomes (1)

• PET imaging

  PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.

  in 3 days

Study Arms (1)

amyloid PET、T807 PET

EXPERIMENTAL

PET/CT

Drug: 1. amyloid PET；2. T807 PET

Interventions

1. amyloid PET；2. T807 PET DRUG

1. Dynamic PET acquisition for 60 minutes will be acquired after injection of 10 mCi 11C-PiB (39 frames: 8 x 15 seconds, 4 x 60 seconds, 27 x120 seconds). 2. Dynamic PET imaging 3D acquisition will be acquired 80 minutes after injection of 10 mCi 18F-T807 (4 x 300 seconds)

amyloid PET、T807 PET

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICH：
• Age：above 20 years old.
• Evidence of intraparenchymal hemorrhage on CT or MRI.
• Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.
• AD：
• Age：above 20 years old.
• Patients who fulfills the clinical criteria of possible or probable Alzheimer's disease (AD).51
• Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.
• Control：
• Age：above 20 years old.
• Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.

You may not qualify if:

• ICH：
• patients with potential causes of hemorrhage including trauma, structural lesion, brain tumor, or coagulopathy due to systemic disease or medication.
• 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.
• Patients with pregnancy or recently having a plan for pregnancy.
• Patients with breast feeding or recently having a plan for breast feeding.
• Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy history.
• Patient or family who does not agree to participate in the study.
• patient with high risk by doctor evaluate.
• AD：
• 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.
• Patients with pregnancy or recently having a plan for pregnancy.
• Patients with breast feeding or recently having a plan for breast feeding.
• Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy history.
• Patient or family who does not agree to participate in the study.
• patient with high risk by doctor evaluate.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Intracranial Hemorrhages; Alzheimer Disease; Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: September 27, 2018
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)