Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroinflammation in Alzheimer's Disease

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: NCT04274998
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

This research study is being done to learn more about inflammation in the brain using Positron Emission Tomography/Computed Tomography (PET/CT) imaging in people with Alzheimer's Disease/Mild Cognitive Impairment or healthy controls.

If the subject agrees to be in this study, she/ he will have two types of PET/CT scans on the same day. The subject may have a screening visit before the PET/CT scan visit if the investigator needs to confirm the subject is able to be in the study.

A blood sample will be taken before the scans. Additional blood samples will be taken during the PET scans. Subjects must also agree to have an MRI scan for this research study if she/he has not had a recent scan that the study doctor decides can be used for this study.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Healthy Volunteer Drug: [11C]PBR28 and[18F]NOS Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of in Vivo Neuroinflammation in Alzheimer's Disease Using Novel Positron Emission Tomography (PET/CT) Imaging
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patient with Alzheimer disease
Patient is diagnosed with Mild Cognitive Impairment or Alzheimer's disease.
Drug: [11C]PBR28 and[18F]NOS
PET/CT imaging will be used to evaluate neuroinflammation in the brain using the investigational radiotracer [11C]PBR28 followed by a second investigational radiotracer [18F]NOS. Each subject will have two positron emission tomography/computed tomography (PET/CT) scan sessions performed on the same day, first with [11C]PBR28 followed by [18F]NOS.

Experimental: Healthy volunteer
Subject must be a Healthy.
Drug: [11C]PBR28 and[18F]NOS
PET/CT imaging will be used to evaluate neuroinflammation in the brain using the investigational radiotracer [11C]PBR28 followed by a second investigational radiotracer [18F]NOS. Each subject will have two positron emission tomography/computed tomography (PET/CT) scan sessions performed on the same day, first with [11C]PBR28 followed by [18F]NOS.




Primary Outcome Measures :
  1. understanding the uptake of [18F]NOS in the human brain in AD/MCI and Healthy Controls and compare to same-day [11C]PBR28 uptake using PET/CT scan [ Time Frame: 3 years ]
    The primary outcome measure will be comparison of whole brain GM binding between controls and the MCI/AD group. the investigator will compare groups with a t-test. the investigator will evaluate the correlation of whole brain GM binding of 11C-PBR28 and 18F-NOS.


Secondary Outcome Measures :
  1. Comparing the patterns of [18F]NOS and [11C]PBR28 brain uptake with patterns of cerebral amyloidosis and neurodegeneration using PET/CT [ Time Frame: 3 years ]
    Secondary outcome measures for will include regional and voxel-wise comparisons between binding of the tracers. Correlation between regional 11C-PBR28 or 18F-NOS binding and either amyloid PET SUVR (calculated with cerebellar gray matter reference) or GM volumetric measurements will be evaluated using Pearson's r and rank sum correlation initially using false discovery rate (FDR)-corrected<0.05 statistical thresholds.



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

Inclusion Criteria (HC cohort only):

  1. - Males and females ≥ 55 years of age
  2. Part of the UPenn ADC research cohort with designation of cognitively normal per ADC database.
  3. A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be negative by the study PI.
  4. High affinity carrier of the rs6971 TSPO polymorphism (whole genome sequencing is available from the UPenn ADC research cohort and will be interrogated for this polymorphism)
  5. Mini-mental status exam (MMSE) score of 28 or higher per ADC database.
  6. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Inclusion Criteria (AD/MCI cohort only)

  1. Males and females ≥ 55 years of age
  2. Part of the Upenn ADC research cohort with designation that the presence of Alzheimer's pathology is likely per ADC database.
  3. A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be positive by the study PI.
  4. High affinity carrier of the rs6971 TSPO polymorphism (whole genome sequencing is available from the UPenn ADC research cohort and will be interrogated for this polymorphism)
  5. Mini-mental status exam (MMSE) score of 14-27 per ADC database.
  6. Subjects must have a designated study partner to accompany them to study visits

Exclusion Criteria (HC and PD cohorts):

  1. Females of child-bearing potential will not be included, female subjects must be post-menopausal or surgically sterile
  2. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report
  3. History of head trauma or evidence of structural abnormalities such as a major stroke or mass on MRI that in the opinion of an investigator may interfere with the uptake of applicable radiotracer as assessed by medical record review and/or self-report
  4. Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation.
  5. Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
  6. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  7. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation 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): NCT04274998


Contacts
Layout table for location contacts
Contact: Zeinab Helili 215-746-3230 Zeinab.Helili@pennmedicine.upenn.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Zeinab Helili    215-746-3230    zeinab.helili@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    Erin.Schubert@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04274998    
Other Study ID Numbers: 834090
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders