Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PET Tau - Neurodegenerative Disease Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03143374
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 (AD), Parkinson's disease (PD), Lewy body disease (DLB) and Frontotemporal degeneration (FTD).

Condition or disease Intervention/treatment
Parkinson Disease Device: [18F]T807 (also known as 18F-AV- 1451)

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]T807 (also known as 18F-AV- 1451) is a specialized radioactive PET tracer that sticks to the tau protein in the brain. In this study, researchers will use [18F]T807 to form images of tau binding in the brain. [18F]T807 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]T807 is in imaging patients who have problems with thinking, remembering, speech, and visual activities, and may be diagnosed with different types of Alzheimer's disease, Parkinson's disease, Lewy body disease and Frontotemporal degeneration. 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Positron Emission Tomography (PET) Imaging of Tau Pathology in Neurodegenerative Disease
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: [18F]T807 (also known as 18F-AV- 1451)

    experimental PET/CT scan of the brain. In this scan, imaging is done with specialized cameras that can pick up radiation signals given off by a radioactive tracer and determine where the signals come from.

    The tracer used for this study is called [18]FT807 (also known as 18F-AV-1451). [18]FT807 is a specialized radioactive PET tracer used to detect the presence of tau proteins in the brain. [18]FT807 is an experimental tracer that has been studied in patients with known or suspected Alzheimer's disease, Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBS/CBD). In this study, patients will have one (1) [18F]T807 PET/CT scan performed at the University of Pennsylvania. The [18F]T807 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 Measures :
  1. regional anatomic distribution of PET-tau uptake in dementia syndromes and PET-Tau uptake with neuropsychology and MRI regional GM atrophy at baseline. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. •longitudinal neuropsychological and regional MRI decline in dementia syndromes compared to baseline regional PET-tau uptake [ Time Frame: 2 years ]

Other Outcome Measures:
  1. • CSF total and phosphorylated (p-tau/t-tau) tau and regional PET-tau uptake in dementia syndromes [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible subjects will have a clinical diagnosis consistent with published criteria for AD/MCI (i.e. amnestic AD or amnestic/non-amnestic mild-cognitive impairment, PCA), FTLD (i.e. bvFTD, PPA, CBD, PSP, FTD-ALS) or DLB (i.e. PD, PDD, DLB).
Criteria

INCLUSION CRITERIA FOR NEURODEGENERATIVE SUBJECTS

  1. Participants has been diagnosed with one of the following neurodegenerative diseases: Frontotemporal Degeneration, Primary Progressive Aphasia, Corticobasal Degeneration, Progressive Supranuclear Palsy, Mild Cognitive Impairment, Alzheimer's Disease, Posterior Cortical Atrophy, Parkinson's Disease, Parkinson's Disease Dementia, Dementia with Lewy Bodies, Multiple Systems Atrophy, Amyotrophic Lateral Sclerosis or Amyotrophic Lateral Sclerosis with Frontotemporal Degeneration.
  2. Participants will be 18 years of age or older
  3. 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.
  4. Participants must be willing and able to comply with scheduled visits and imaging procedures.
  5. An Electrocardiogram (ECG) is required prior to the first [18F]T807 PET/CT scan. If the participant has had an ECG completed within 3 months prior to the enrollment date, the ECG may be used for this study, if not; an ECG will be completed as part of this study's activities at screening. At each longitudinal visit participants will be queried to any changes to their cardiac health since their last visit. If there have been changes that put the participant at high risk for Torsades de Pointes an ECG will be performed to evaluate for a prolonged QT interval. If the participant has had an ECG completed within 3 months prior to the visit date, the ECG may be used for the evaluation.
  6. 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

  1. Participants will be 18 years of age or older.
  2. 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.
  3. Participants must be willing and able to comply with scheduled visits and imaging procedures.
  4. An ECG is required prior to the first [18F]T807 PET/CT scan. If the participant has had an ECG completed within 3 months prior to the enrollment date, the ECG may be used for this study, if not; an ECG will be completed as part of this study's activities at screening. At each longitudinal visit participants will be queried to any changes to their cardiac health since their last visit. If there have been changes that put the participant at high risk for Torsades de Pointes an ECG will be performed to evaluate for a prolonged QT interval. If the participant has had an ECG completed within 3 months prior to the visit date, the ECG may be used for the evaluation.

6. 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

  1. 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
  2. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
  3. QTc > 450 msec on screening ECG.
  4. Any medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS

  1. No 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.
  2. No current use of psychoactive medications or substances per medical record review or self-report.

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): NCT03143374


Contacts
Layout table for location contacts
Contact: Courtney M Igne, MS 215-662-3596 cigne@mail.med.upenn.edu
Contact: Katie Pizziketti, BA 215-349-5873 katie.pizziketti@uphs.upenn.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Courtney M Igne, MS    215-662-3596    cigne@mail.med.upenn.edu   
Contact: Katie Pizziketti, BA    215-349-5873    katie.pizziketti@uphs.upenn.edu   
Principal Investigator: Murray Grossman, PhD, MD         
Sponsors and Collaborators
University of Pennsylvania
Avid Radiopharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Murray Grossman, PhD, MD University of Pennsylvania

Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03143374     History of Changes
Other Study ID Numbers: 824867
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders