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Clinical Core

临床核心

基本信息

批准号：
10023218
负责人：
JOEL Synes PERLMUTTER
金额：
$ 78.08万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-24 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10023218
关键词：
Amyloid beta-Protein Area Autopsy Autoradiography Brain California Clinical Clinical Data Clinical Investigator Clinical Trials Design Cohort Studies Collaborations Data Data Collection Data Storage and Retrieval Degenerative Disorder Development Devices Diagnosis Exclusion Criteria Freezing Frontotemporal Dementia Genes Human Idiopathic Parkinson Disease Image Institution Institutional Review Boards International Kinetics Lead Letters Longitudinal cohort Magnetic Resonance Imaging Measures Movement Disorders Multicenter Studies Multicenter Trials Multiple System Atrophy Neurodegenerative Disorders Online Systems Parkinson Disease Parkinsonian Disorders Participant Patient Selection Patients Pennsylvania Positron-Emission Tomography Process Progressive Supranuclear Palsy Protocols documentation RTN4 gene Radiopharmaceuticals Research Personnel Resolution Role San Francisco Scheme Selection Criteria Site Specificity Standardization Structure Tauopathies Testing Tissues Tracer Universities Validation Washington Work alpha synuclein base brain tissue cohort data management data sharing dosimetry experience first-in-human human imaging kinetic model method development pre-clinical radiotracer safety assessment synucleinopathy tau Proteins tau mutation web-based tool

项目摘要

ABSTRACT This Clinical Core will implement first in human PET imaging with new radiotracers targeting α-synuclein (α-syn) and 4 repeat tau (4R tau). Radiotracers will be developed pre-clinically in the Med Chem Core and in Projects 1 and 2 focusing on α-syn and 4R tau, respectively. We will focus α-syn radiotracers on two synucleinopathies, Parkinson disease (PD) and Multiple Systems Atrophy (MSA), and focus 4R tau radiotracers on two different tauopathies, progressive supranuclear palsy (PSP) and familial frontotemporal dementias (FTD) due to mutation in Microtubule Associated Protein Tau (MAPT) gene. We will draw participants and interact with multiple ongoing clinical cohorts of FTD, PSP, PD and MSA. The Clinical Core functions include interaction with the Executive Committee to determine when to start human studies, coordinate required regulatory activities for radiotracer candidates, carry out early safety assessments including whole body dosimetry studies at Penn; coordinate patient selection criteria, centrally collect and serve all imaging and demographic data, coordinate tracer kinetic methods development and validation for human imaging, and coordinate all data to efficiently enable GO-NOGO decisions for candidate radiotracers. Radiotracers for α-syn will be tested in two different synucleinopathies, PD and MSA whereas, 4R tau radiotracers will be tested in PSP and FTD patients. As a final check on diagnosis and specificity of candidate radiotracers, we will request all patient participants to permit postmortem brain donation for autoradiography of relevant radiotracers on fresh frozen brain tissues. Additionally, this Core will interact with multiple ongoing studies with cohorts studying PD, MSA, PSP and FTD. Finally, a robust data sharing plan facilitates collaboration and use of support documents and imaging data.

摘要