184 Participants Needed

PET Imaging for Alzheimer's Disease

MD
RB
TN
Overseen ByTara N Turon, C.R.N.P.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Florbetaben PET imaging has been generally well tolerated in clinical trials, with mild to moderate side effects like injection site redness, irritation, and pain. No serious adverse reactions related to florbetaben have been reported.23567

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

RB

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

Healthy volunteer subjects must meet the following criteria:
Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies
Patients must meet the following criteria:
See 9 more

Exclusion Criteria

I do not have any untreated serious illnesses that would make joining unsafe.
I haven't taken NSAIDs, aspirin, corticosteroids (except for skin), or immunosuppressants like methotrexate in the last month.
I cannot travel to the NIH for treatment.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Imaging

Participants undergo MRI and PET scans to measure COX-1 and COX-2 levels in the brain

1-2 days
2-5 visits (in-person)

Follow-up

Participants are monitored for any adverse effects and data is collected for analysis

1-2 weeks

Treatment Details

Interventions

  • 11C-MC1
  • 11C-PS13
  • 18f-florbetaben
Trial OverviewThe trial tests PET imaging agents (11C-MC1, 11C-PS13, 18f-florbetaben) to measure brain inflammation in neurodegenerative disorders versus healthy individuals. It involves MRI scans and two PET scans using these agents to compare COX enzyme levels between diseased and healthy brains.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Only one armExperimental Treatment3 Interventions
All subjects receive the same tests

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials
3,007
Recruited
2,852,000+

Findings from Research

In a study of 107 patients with suspected dementia, the use of [18F]-florbetaben (FBB)-PET significantly improved diagnostic clarity, allowing a final diagnosis to be established in 83% of previously unclear cases.
FBB-PET was particularly effective in differentiating Alzheimer's dementia from fronto-temporal dementia, changing the most likely diagnosis in 41% of cases, which is crucial for guiding future treatment options.
Additive value of amyloid-PET in routine cases of clinical dementia work-up after FDG-PET.Brendel, M., Schnabel, J., Schönecker, S., et al.[2018]
Florbetaben, a novel β-amyloid PET tracer, was found to be safe and effective in distinguishing between patients with Alzheimer's disease (AD) and healthy controls, with 9 out of 10 AD patients showing β-amyloid positivity compared to only 1 out of 10 healthy controls.
The study demonstrated that the whole brain β-amyloid load derived from PET scans correlated significantly with cognitive decline, as measured by Mini-Mental State Examination scores, suggesting its potential as a surrogate marker for disease severity.
Individualized quantification of brain β-amyloid burden: results of a proof of mechanism phase 0 florbetaben PET trial in patients with Alzheimer's disease and healthy controls.Barthel, H., Luthardt, J., Becker, G., et al.[2022]
Florbetaben, an 18F-labeled PET tracer, has shown promising results in diagnosing Alzheimer's disease, with a sensitivity of 80% and specificity of 91% in distinguishing patients with probable AD from healthy controls in a recent multi-center trial.
Current research is focused on validating florbetaben's effectiveness by correlating PET imaging results with post-mortem evaluations and assessing its ability to predict progression to Alzheimer's in individuals with mild cognitive impairment.
Florbetaben to trace amyloid-β in the Alzheimer brain by means of PET.Barthel, H., Sabri, O.[2022]

References

Additive value of amyloid-PET in routine cases of clinical dementia work-up after FDG-PET. [2018]
Individualized quantification of brain β-amyloid burden: results of a proof of mechanism phase 0 florbetaben PET trial in patients with Alzheimer's disease and healthy controls. [2022]
Florbetaben to trace amyloid-β in the Alzheimer brain by means of PET. [2022]
Evaluation of early-phase [18F]-florbetaben PET acquisition in clinical routine cases. [2022]
Cerebral amyloid-β PET with florbetaben (18F) in patients with Alzheimer's disease and healthy controls: a multicentre phase 2 diagnostic study. [2022]
Beta-amyloid imaging with florbetaben. [2022]
[(18)F]Florbetaben: a review in β-amyloid PET imaging in cognitive impairment. [2022]
Radiopharmaceuticals for positron emission tomography investigations of Alzheimer's disease. [2021]
Clinical evaluation of [18F] JNJ-64326067, a novel candidate PET tracer for the detection of tau pathology in Alzheimer's disease. [2021]
Using PET with 18F-AV-45 (florbetapir) to quantify brain amyloid load in a clinical environment. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Imaging Brain Metabolism and Pathology in Alzheimer's Disease with Positron Emission Tomography. [2020]
12.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Simple Synthesis of [18F] AV-45 and its Clinical Application in the Diagnosis of Alzheimer's Disease. [2023]