Start: July 3, 2019
End: March 3, 2023
What Is This Study About?
Radioligands are radioactive substances that are injected into the body to help diagnosis diseases or study processes within the body. This study will test the radiogland 11C-ER176 for showing brain inflammation on positron emission tomography (PET) scans in people with a neurodegenerative disease, such as Alzheimer's or frontotemporal dementia, compared to healthy individuals. Participants will undergo two PET scans and an MRI, as well as brief interviews, medical tests, memory and thinking tests, and an optional DNA test. Participants will be invited to return for repeat evaluations yearly afterward for several years.
Do I Qualify To Participate in This Study?
Participants with Neurodegenerative Disease
- Diagnosis by a neurologist of frontotemporal dementia, frontotemporal lobar degeneration, primary progressive aphasia, semantic dementia, motor neuron disorder, amyotrophic lateral sclerosis, primary lateral sclerosis, progressive bulbar palsy, corticobasal syndrome, Huntington's disease, Alzheimer's disease, or other related adult-onset neurodegenerative disease
Participants with Increased Risk of Neurodegenerative Disease
- Known family history or other risk of an adult-onset genetic neurodegenerative disease, and/or mutation in a gene known to cause an adult-onset neurodegenerative disease
Must NOT have:
Participants with Neurodegenerative Disease or at Increased Risk
- Other major neurological or medical diseases that may cause progressive weakness or cognitive dysfunction, such as structural brain or spinal cord disease, metabolic diseases, paraneoplastic syndromes, infectious diseases, peripheral neuropathy, radiculopathy (pinched nerve), or other significant neurological abnormalities
- Unstable medical condition that would make participation unsafe (e.g., active infection or untreated malignancy)
- Require daytime ventilator support
- Are unable to travel to the National Institutes of Health in Bethesda, MD
- History of medical illness or injury with the potential to affect study data interpretation
- Any medical situation that conflicts with study procedures, including active infection and untreated malignancy
- Significant abnormalities on laboratory tests
- Recent exposure to radiation related to research (e.g., PET scan from other research) that, when combined with this study, would be above allowable limits
- Inability to lie flat and/or still on camera bed for at least 2 hours, including claustrophobia, weight greater than the scanner maximum, and uncontrollable behavioral symptoms
- Pregnant or breastfeeding
- Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function
- Unable to have a magnetic resonance imaging (MRI) scan (e.g., pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metal implants, permanent eyeliner, implanted delivery pumps, shrapnel fragments, metal fragments in the eye)
- National Institute of Mental Health staff members or employees of the National Institutes of Health who are subordinates/relatives/coworkers of investigators
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Maria D Ferraris Araneta, CRNP
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
National Institutes of Health Clinical Center
Bethesda, MD 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Lead: National Institute of Mental Health (NIMH)
Source: ClinicalTrials.gov ID: NCT03958630