PET Imaging for Alzheimer's Disease
Trial Summary
What is the purpose of this trial?
Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Eligibility: Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181. Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured. Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs. Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan. Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. Specifically, you should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for two weeks before the PET scan, and aspirin, corticosteroids (except skin products), or immunosuppressants must not have been taken in the prior month.
What data supports the effectiveness of the drug 18F-florbetaben in PET imaging for Alzheimer's disease?
Research shows that 18F-florbetaben is effective in helping diagnose Alzheimer's disease by detecting amyloid-β in the brain, with a sensitivity of 80% and specificity of 91% in distinguishing Alzheimer's patients from healthy individuals. This means it can accurately identify the presence of Alzheimer's-related brain changes in most cases.12345
Is florbetaben PET imaging safe for humans?
How does PET imaging differ from other treatments for Alzheimer's disease?
PET imaging for Alzheimer's disease is unique because it uses special tracers to visualize brain changes, such as amyloid plaques and tau tangles, which are not visible with standard imaging techniques. This allows for early detection and monitoring of the disease's progression, unlike traditional treatments that focus on managing symptoms.89101112
Research Team
Robert B Innis, M.D.
Principal Investigator
National Institute of Mental Health (NIMH)
Eligibility Criteria
This trial is for adults over 18 with neurodegenerative diseases like Alzheimer's, Parkinson's, or ALS and are in good health. It also includes healthy volunteers from specific NIMH studies. Participants must understand the study, sign consent, have no major neurological issues besides their diagnosis, not be on certain anti-inflammatory drugs or immunosuppressants recently, and can't be pregnant or HIV positive.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo MRI and PET scans to measure COX-1 and COX-2 levels in the brain
Follow-up
Participants are monitored for any adverse effects and data is collected for analysis
Treatment Details
Interventions
- 11C-MC1
- 11C-PS13
- 18f-florbetaben
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Mental Health (NIMH)
Lead Sponsor