Official Title
Assessment of Immunological and Vascular Dysfunction in Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (PASC) Using TSPO PET and MRI
Brief Summary

The overarching goal of this study is to develop PET/MR techniques for the diagnosis ofneuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is thatimmunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediateneuropsychiatric PASC (NP-PASC).

Detailed Description

Not Provided

Active, not recruiting
Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection

Drug: PET Tracer

Standard radiopharmaceutical injected via intravenous catheter during PET-MR scanning.
Other Name: C11-ER176

Drug: MRI Tracer

Injected via intravenous catheter during PET-MR scanning.
Other Name: Gadolinium-Based Contrast Agent (GBCA)

Device: 3T PET/MRI

Used to evaluate neuroinflammation and cerebrovascular measures. Some MRI image
acquisitions will employ work in progress (WIP) sequences, including ASL (Arterial Spin
Labeling), Diffusion and T2-weighted EPI (DT2W), Golden-angle radial sparse parallel
(GRASP) DCE-MRI, and Magnetization Transfer (MT) imaging.

Eligibility Criteria

Inclusion Criteria:

- Neuropsychiatric symptoms are defined as respectively a) objective cognitive
dysfunction on bedside cognitive testing (ACE-III (Addenbrooke's Cognitive
Examination III) =< 86/100, at least 12th grade educational level), and/or b)
anxiety, depression or psychotic illness as indicated by the DSM-5 diagnostic
criteria, evaluated with the MINI (Mini International Psychiatric Interview) or
SCID-5 (Structured Clinical Interview for DSM-5 Disorders, Research Version). It is
expected some patients may fall into both categories (cognitive and psychiatric
complications), in which case they will be included in this study.

- Infection with SARS-CoV-2 (3-12 months before study) will be verified based on
positive PCR test results provided by the NYU EMR or subject records. Investigators
will further record the clinical history and perform nucleoprotein- and
spike-antibody testing. Anecdotal evidence shows that anti-nucleoprotein and
anti-spike tests will be positive in individuals who had past SARS-CoV-2 infection,
but only anti-spike tests will be positive in individuals who were vaccinated but
did not have past infection, unless the infected individual has already lost the
antibodies due to natural infection .

- Able to sign informed consent as evaluated by the UCSD Brief Assessment of Capacity
to Consent (UBACC) test.

Subgroup Inclusion Criteria

- NP-PASC subjects will have new onset a) cognitive and/or b) psychiatric symptoms
following SARS-CoV-2 infection.

- CC will have a history of SARS-CoV-2 infection but will not meet the criteria for
any DSM-5 diagnosis and will perform within normal limits on cognitive tests.

Exclusion Criteria:

- If vaccinated for SARS-CoV-2, at least 3 months past the last vaccine
administration.

- Subjects with suicidal ideation who require inpatient or intensive level of care, as
determined by a study clinician (Dr. Frankle or Dr. Iosifescu) based on the answers
to the screening interview. These patients will be immediately referred to
appropriate clinical treatment.

- Pregnant women or those who become pregnant as determined by a urine test at the
time of the blood test and on the day of the PET/MR scan.

- Obese individuals (BMI >= 30) and individuals with cardiovascular risk factors
(e.g., uncontrolled high blood pressure, hypercholesterolemia, current tobacco
smokers or smoking in the last 12 months, diabetes mellitus).

- Individuals with history of serious or unstable medical illness associated with
chronic inflammation other than PASC (e.g., rheumatoid arthritis, SLE, etc).

- Current traumatic brain injury. Subjects with a history of chronic pre-existing
neurological disease (multiple sclerosis, degenerative disease such as ALS,
Parkinson disease and any movement disorders, etc), i.e. neurological symptoms
should be new onset for inclusion. Patients with substance use disorders, including
alcohol, active within the last 12 months.

- Clinical or laboratory evidence of hypothyroidism. A thyroid stimulating hormone
(TSH) test will be drawn in blood, and the patient will be excluded if TSH is
abnormal.

- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding
baseline.

- Subjects who had recently taken psychotropic medications will be scanned only after
a period greater than five half-lives since the last dose of their psychotropic
medication. Subjects who choose to start treatment (with psychotropic medication)
for their symptoms immediately will thus be excluded.

- Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm
clip, cochlear implant, presence of shrapnel in strategic locations, metal in the
eye, claustrophobia, or other problems).

- Contraindications for Gadolinium-based MRI contrast (allergies to contrast agents
and kidney health)

- Recent exposure to radiation (i.e., PET from other research) which when combined
with this study would be above the allowable limits of 5 rem per 12 months as
confirmed by the Radiation safety questionnaire.

- If CSF sampling: contraindication for a lumbar puncture (i.e. intracranial mass,
bleeding diathesis, spinal developmental anomalies, or local skin infection
involving the lower back). Complete blood count and coagulation studies will be
drawn, and if abnormal (INR>1.3, platelets less than 100), subjects will be able to
complete imaging studies but will not be eligible for the lumbar puncture procedure
part of the study.

- Unable to sign informed consent or to comply with study assessments.

- Urine will be collected for toxicology screening (amphetamine, barbiturates,
benzodiazepines, cocaine, methadone, opiates, phencyclidine/PCP, THC, and tricyclic
antidepressants). Subjects in whom THC is found will be scanned only after
abstaining for 7 days. A pregnancy test will be performed on all premenopausal women
to ensure exclusion criteria are appropriately screened.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
United States
Locations

NYU Langone Health
New York, New York, United States

Steven Baete, Principal Investigator
NYU Langone Health

NYU Langone Health
NCT Number
Keywords
long COVID
Covid-19
Cognitive Deficit Following COVID-19
Depression and Anxiety following COVID-19
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome