Application of Amyloid PET in Cerebral Amyloid Angiopathy

NCT03542656 | Completed Phase 3

• 1 other identifier: 201404065MIND
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, we will try to enhance the diagnostic potentials of amyloid PET in CAA by combination of dynamic amyloid PET with MRI SWI and MR perfusion images. We will also try to investigate the roles of CAA in patients with drug-related ICH and validate the accuracy of clinical CAA diagnostic criteria. In addition, we will try to study the characteristics of long-term progression of amyloid deposition in CAA patients. This project will enroll 100 patients with ICH, 30 patients with AD, and 30 control subjects. Each patient will receive the above image studies, followed by data analysis and comparison.

Conditions

Cerebral Amyloid Angiopathy; Intracranial Hemorrhages; Alzheimer Disease

Keywords

Stroke; intracerebral hemorrhage; amyoid PET; cerebral amyloid angiopathy

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

EXPERIMENTAL

PET/CT

Drug: amyloid PET

Interventions

amyloid PET DRUG

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).

amyloid PET

Eligibility Criteria

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

You may qualify if:

• Age：above 20 years old with ICH or AD, or control subjects.
• Patient agrees to participate in the study and receive cerebral amyloid PET and MRI SWI and perfusion studies.

You may not qualify if:

• 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.
• Patients with pregnancy or recently having a plan for pregnancy.
• Patient or family who does not agree to participate in the study.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

Location

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 20, 2018
• First Posted: May 31, 2018
• Study Start: September 11, 2014
• Primary Completion: February 17, 2016
• Study Completion: March 22, 2018
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)