Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Participants will undergo a general and neurological exam, a standard battery of neuropsychological tests to measure cognitive function, blood tests for analysis of TSPO polymorphisms, MRI of the brain, and PET imaging with the [11C]ER176 TSPO radioligand and [11C]PIB amyloid radioligand. Participants will be invited to return for repeat evaluations approximately 1, 2, and 3-5 years after their initial evaluation. Outcome measures Brain PET and MRI scans will be co-registered for anatomic definition of regions of interest, and standard uptake value (SUV) will be calculated in various brain regions. [11C]ER176 PET data will be analyzed with compartmental modeling. [11C]PIB PET and MRI data will be adjunctly used for segregating the collected data by disease subtype. For the primary objective, we will compare TSPO radioligand uptake of healthy controls compared to subjects with neurodegenerative diseases. For secondary objectives, we will determine if neuroanatomical regions of tracer uptake differ across different neurodegenerative disease subtypes, and if interval change of tracer uptake correlates with disease progression in longitudinal imaging of individual subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03958630
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase Phase 1
Start date July 3, 2019
Completion date December 4, 2023

See also
  Status Clinical Trial Phase
Completed NCT05686486 - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes N/A
Terminated NCT05451693 - Outreach-ER: A Dementia Care Intervention Program
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Enrolling by invitation NCT06040294 - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills N/A
Completed NCT05114187 - An Internet-Based Education Program for Care Partners of People Living With Dementia N/A
Recruiting NCT06322121 - Vascular Aspects in Dementia: Part 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Recruiting NCT03462485 - Pilot Study of the Effects of Playing Golf on People With Dementia N/A
Active, not recruiting NCT03677284 - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia N/A
Completed NCT03849937 - Changing Talk Online (CHATO) Study N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Recruiting NCT06033066 - Financial Incentives and Recruitment to the APT Webstudy N/A
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT05684783 - Dementia Champions in Homecare
Completed NCT03147222 - Function Focused Care: Fracture Care at Home N/A