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PET Tau - Neurodegenerative Disease Imaging

Primary Purpose

Neurodegenerative Disease

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

18F-AV-1451

About this trial

This is an interventional diagnostic trial for Neurodegenerative Disease focused on measuring Neurodegenerative Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA FOR NEURODEGENERATIVE SUBJECTS

Participants has been diagnosed with one of the following neurodegenerative diseases: FTD, PPA, CBD, PSP, MCI, AD, PCA, PD, PDD, DLB, MSA, ALS or FTD- ALS
Participants will be 18 years of age or older
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the subject is unable to provide informed consent, the subject's legal representative may consent on behalf of the patient, but the patient will be asked to confirm assent.
Participants must be willing and able to comply with scheduled visits and imaging procedures.
A brain MRI is required to participate in this study. If a brain MRI has been performed within 6 months prior to enrollment in this study and is of adequate quality, in the judgment of an investigator, the MRI may be used for the study analysis. Subjects who do not have a brain MRI will undergo a brain MRI as part of one of the Center's other ongoing study protocols.

INCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS

Participants will be 18 years of age or older.
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Participants must be willing and able to comply with scheduled visits and imaging procedures.
A brain MRI is required to participate in this study. If a brain MRI has been performed within 6 months prior to enrollment in this study and is of research quality, that scan may be used for the study analysis. Subjects who do not have a brain MRI will undergo a brain MRI as part of one of the Center's other ongoing study protocols.

EXCLUSION CRITERIA FOR ALL SUBJECTS

Females who are pregnant or breast feeding at the time of the baseline PET/CT scan will not be eligible for this study. A urine pregnancy test will be performed in women of child-bearing potential at screening and within 24 hours of any scheduled PET/CT or MRI scanning
Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
Any medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
The investigators may choose to exclude participants with clinically significant cardiovascular disease and/or documented abnormalities on ECG out of an abundance of caution.

ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS

Pre-existing psychiatric conditions (e.g., active depression, schizophrenia, or active anxiety) or neurological conditions (e.g., stroke, epilepsy, head trauma) per medical record review or self-report.
Current use of psychoactive medications or substances per medical record review or self-report.

Sites / Locations

University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positron Emission Tomography (PET/CT) Imaging of Tau Pathology in Neurodegenerative Disease

Arm Description

Individuals who have been diagnosed with FTD, PPA, CBD, PSP, MCI, AD, PCA, PD, PDD, DLB, MSA, ALS or FTD-ALS may participate in this study if they are 18 years of age or older; most participants will be receiving care at the clinical practices of the of the University of Pennsylvania and at Pennsylvania Hospital Department of Neurology. Healthy control subjects will also be recruited for this study.

Outcomes

Primary Outcome Measures

Regional uptake

Examine regional anatomic distribution of PET-tau uptake comparatively in dementia syndromes and PET-Tau uptake with neuropsychology and MRI regional GM atrophy at baseline collected under other center protocols. Uptake with neuropsychology and MRI regional GM atrophy at baseline.

Secondary Outcome Measures

Changes over time

Use regression to relate longitudinal neuropsychological and regional MRI decline in dementia syndromes to baseline regional PET-tau uptake.

CSF Correlate

Correlate CSF total and phosphorylated (p-tau/t-tau) tau with regional PET-tau uptake in dementia syndromes at baseline.

Full Information

NCT ID

NCT03143374

First Posted

November 2, 2016

Last Updated

August 22, 2023

Sponsor

University of Pennsylvania

Collaborators

Avid Radiopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03143374

Brief Title

PET Tau - Neurodegenerative Disease Imaging

Official Title

Positron Emission Tomography (PET) Imaging of Tau Pathology in Neurodegenerative Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

Avid Radiopharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown to build up in the brains of patients with injury to brain cells, including Alzheimer's disease, Parkinson's disease, Lewy body disease and Frontotemporal degeneration. 18F-AV-1451 (formally known as 18F-T807) is a specialized radioactive PET tracer that sticks to the tau protein in the brain. In this study, researchers will use 18F-AV-1451 to form images of tau binding in the brain. 18F-AV-1451 is an investigational or experimental imaging agent that has not yet been approved by the Food and Drug Administration for use in brain imaging. In this study, researchers want to find out how accurate and useful 18F-AV-1451 is in imaging patients who have problems with thinking, remembering, speech, and visual activities, and may be diagnosed with different types of neurodegenerative disease. This study will help test how imaging measures may provide information that could be used to determine diagnosis for patients in the future. The results of the PET/CT scan will be compared with other information obtained under related protocols, including brain magnetic resonance imaging (MRI), spinal fluid and cognitive test results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodegenerative Disease

Keywords

Neurodegenerative Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Positron Emission Tomography (PET/CT) Imaging of Tau Pathology in Neurodegenerative Disease

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-AV-1451

Other Intervention Name(s)

formally known as 18F-T807, 7-(6-[18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole

Intervention Description

The experimental tracer used for this study is called 18F-AV-1451 is a specialized radioactive PET tracer used to detect the presence of tau proteins in the brain. Participants will undergo a baseline 18F-AV-1451 brain scan. If funding is available, participants will be asked to return for one or more longitudinal visits, including a 18F-AV-1451 brain scan, every 9 to 18 months after the prior visit. The 18F-AV-1451 PET/CT scan will require up to 3 hours of time, including preparation. The scan will take place using PET/CT scanners in the Perelman Center for Advanced Medicine or the Hospital of the University of Pennsylvania.

Primary Outcome Measure Information:

Title

Regional uptake

Description

Time Frame

7 years

Secondary Outcome Measure Information:

Title

Changes over time

Description

Use regression to relate longitudinal neuropsychological and regional MRI decline in dementia syndromes to baseline regional PET-tau uptake.

Time Frame

7 years

Title

CSF Correlate

Description

Correlate CSF total and phosphorylated (p-tau/t-tau) tau with regional PET-tau uptake in dementia syndromes at baseline.

Time Frame

7 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA FOR NEURODEGENERATIVE SUBJECTS Participants has been diagnosed with one of the following neurodegenerative diseases: FTD, PPA, CBD, PSP, MCI, AD, PCA, PD, PDD, DLB, MSA, ALS or FTD- ALS Participants will be 18 years of age or older Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the subject is unable to provide informed consent, the subject's legal representative may consent on behalf of the patient, but the patient will be asked to confirm assent. Participants must be willing and able to comply with scheduled visits and imaging procedures. A brain MRI is required to participate in this study. If a brain MRI has been performed within 6 months prior to enrollment in this study and is of adequate quality, in the judgment of an investigator, the MRI may be used for the study analysis. Subjects who do not have a brain MRI will undergo a brain MRI as part of one of the Center's other ongoing study protocols. INCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS Participants will be 18 years of age or older. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Participants must be willing and able to comply with scheduled visits and imaging procedures. A brain MRI is required to participate in this study. If a brain MRI has been performed within 6 months prior to enrollment in this study and is of research quality, that scan may be used for the study analysis. Subjects who do not have a brain MRI will undergo a brain MRI as part of one of the Center's other ongoing study protocols. EXCLUSION CRITERIA FOR ALL SUBJECTS Females who are pregnant or breast feeding at the time of the baseline PET/CT scan will not be eligible for this study. A urine pregnancy test will be performed in women of child-bearing potential at screening and within 24 hours of any scheduled PET/CT or MRI scanning Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician Any medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study The investigators may choose to exclude participants with clinically significant cardiovascular disease and/or documented abnormalities on ECG out of an abundance of caution. ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS Pre-existing psychiatric conditions (e.g., active depression, schizophrenia, or active anxiety) or neurological conditions (e.g., stroke, epilepsy, head trauma) per medical record review or self-report. Current use of psychoactive medications or substances per medical record review or self-report.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chace Brokaw

Phone

860-338-9947

Chace.Brokaw@Pennmedicine.upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Irwin, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chace Brokaw

Phone

860-338-9947

Chace.Brokaw@Pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

David Irwin, MD

12. IPD Sharing Statement

Plan to Share IPD

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