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Application of Amyloid PET in Cerebral Amyloid Angiopathy (CAA)

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ClinicalTrials.gov Identifier: NCT03542656
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Amyloid Angiopathy Intracranial Hemorrhages Alzheimer Disease Drug: amyloid PET Phase 3

Detailed Description:

Intracranial hemorrhage (ICH) consists of about a quarter of stroke subtype. For elderly, cerebral amyloid angiopathy (CAA) is a common etiology of ICH. In patients with CAA, abnormal beta amyloid protein diffusely deposits at cerebral vasculatures, which disrupts the normal vessel structure and increases the risk of bleeding. The standard diagnosis for CAA requires pathological evidences of amyloid deposition at cerebral arteries. Clinically, a diagnosis of CAA-related ICH is usually only made in an elderly developing cortical or subcortical lobar ICH without undergoing biopsy. Brain images using the SWI sequence of MRI study may show several lobar microbleeds in patients with CAA. However, there is still no direct and precise non-invasive diagnostic tool for CAA until now.

Amyloid PET, using 11C-PiB to image amyloid burden, has been used for detecting the cerebral amyloid protein deposition in patients with Alzheimer's dementia (AD) for years. Recently, amyloid PET has also been applied in diagnosis of CAA. CAA patients showed diffusely increased global PiB retention as compared to control subjects and the distribution of PiB retention is also different from that seen in patients with AD in general. Nevertheless, the applications of amyloid PET in CAA diagnosis are still not well established and many important issues still need to be extensively addressed. For example, amyloid PET sometimes is not able to exactly distinguish CAA patients from control and AD subjects. The roles of CAA in patients with drug-related ICH are still unclear. The accuracy of CAA diagnosis using clinical criteria still needs further validation. In addition, the characteristics for long-term progression of amyloid deposition are still unknown in CAA patients.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of Amyloid PET in Cerebral Amyloid Angiopathy
Actual Study Start Date : September 11, 2014
Actual Primary Completion Date : February 17, 2016
Actual Study Completion Date : March 22, 2018


Arm Intervention/treatment
Experimental: amyloid PET
PET/CT
Drug: amyloid PET
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).




Primary Outcome Measures :
  1. PET imaging [ Time Frame: in 3 days ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542656


Locations
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Taiwan
National Taiwan Univeristy Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03542656     History of Changes
Other Study ID Numbers: 201404065MIND
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Stroke
intracerebral hemorrhage
amyoid PET
cerebral amyloid angiopathy

Additional relevant MeSH terms:
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Alzheimer Disease
Hemorrhage
Amyloidosis
Intracranial Hemorrhages
Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn