NCT03958630TerminatedPhase 1

PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel TSPO Radioligand

National Institute of Mental Health (NIMH)1 site in 1 country13 target enrollmentStarted: July 3, 2019Last updated: May 1, 2024

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Terminated
Sponsor: National Institute of Mental Health (NIMH)
Enrollment: 13
Locations: 1
Primary Endpoint: Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

Background:

Aging-related progressive neurological disorders include frontotemporal dementia, Lou Gehrig s disease, and Alzheimer s disease. Little is known about what causes these disorders. Brain inflammation may be involved. Researchers want to see if scans using radioactive drugs can show brain inflammation.

Objective:

To see if the drug [11C]ER176 can show inflammation in the brain in people with certain progressive neurological disorders compared to healthy adults. Also to find genes that might be associated with or cause these disorders.

Eligibility:

People ages 18 and older with an aging-related neurological disorder, and healthy adults

Design:

Participants will be screened with a medical history, physical exam, neurological exam, psychiatric history, and blood tests.

Participants will have 2-5 visits for the first session. They will have 2 PET scans and 1 MRI scan. They may have 3 more sessions: 6 months to about 18 months later, 1 year after that, and about 30 months to 5 years after the first visit. There may be up to 20 total visits.

For the scans, participants will lie on a bed that slides into the scanners. For the PET scans, a strap will fix their head in place. A radioactive drug will be injected through a catheter. A needle will guide a thin plastic tube into an arm vein. Additional catheters may be put in place to draw blood. Each PET will take 2 hours. The MRI will take 30 60 minutes.

At each session, participants will have a brief interview, medical history, physical exam, blood and urine tests, heart tests, and memory and thinking tests. They may donate blood for DNA tests.

Detailed Description

Objectives

The primary objective is to explore if human subjects with neurodegenerative diseases exhibit different level of neuroinflammation, as measured by brain uptake of a 3rd generation [11C]ER176 TSPO ligand, compared to control subjects. The secondary objectives are to determine, 1) if [11C]ER176 TSPO brain uptake shows disease-specific patterns across different neurodegenerative diseases and/or genetic mutations, and 2) if longitudinal imaging of individual patients shows a correlation between interval change of tracer uptake and disease progression.

Study population

Adults referred with a clinical diagnosis or with an increased risk of frontotemporal dementia, amyotrophic lateral sclerosis, Alzheimer s disease, other related adult-onset neurodegenerative disorders, or healthy control subjects.

Design

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Parallel
Primary Purpose: Diagnostic
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided