Evaluation of in Vivo Neuroinflammation in Alzheimer's Disease Using Novel Positron Emission Tomography (PET/CT) Imaging

Who is this study for? Patients with Alzheimer's disease
What treatments are being studied? [11C]PBR28 and[18F]NOS
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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 a PET/CT scan using the investigational radiotracer \[18F\]NOS. A subject with a specific genetic polymorphism may also agree to be in the sub-study in which she/he will have another PET/CT scan using the investigational tracer \[11C\]PBR28 for comparison with the FNOS \[18F\]NOS scan. For subjects who agree to this sub-study they may undergo the brain PET/CT scan with \[11C\]PBR28 either on the same day as the \[18F\]NOS PET/CT or on another 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: t
View:

• \- Males and females ≥ 55 years of age

• Part of the UPenn ADC research cohort with designation of cognitively normal per ADC database.

• A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be negative by the study PI.

• Mini-mental status exam (MMSE) score of 28 or higher per ADC database.

• 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.

• Males and females ≥ 55 years of age

• Part of the Upenn ADC research cohort with designation that the presence of Alzheimer's pathology is likely per ADC database.

• A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be positive by the study PI.

• Mini-mental status exam (MMSE) score of 14-27 per ADC database.

• Subjects must have a designated study partner to accompany them to study visits

⁃ 1\. 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)

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Erin Schubert
erinschu@pennmedicine.upenn.edu
215-573-6569
Backup
IIya Nasrallah, MD
IIya.Nasrallah@pennmedicine.upenn.edu
Time Frame
Start Date: 2020-03-03
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 20
Treatments
Experimental: AD/MCI or HC
Main Study: Subjects are diagnosed with Alzheimer's Disease (AD)/Mild Cognitive Imparment (MCI) or are healthy volunteers/controls (HC).
Experimental: AD/MCI or HC with Genetic Polymorphism
Sub-Study: Subjects have a specific genetic polymorphism andare diagnosed with Alzheimer's Disease (AD)/Mild Cognitive Imparment (MCI) or are healthy volunteers/controls (HC).
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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