Brain Amyloid Imaging for Alzheimer's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Claustrophobia, Metallic implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand Alzheimer's disease by using special brain scans to examine amyloid, a protein that can accumulate in the brain and affect memory and thinking. Researchers seek to determine how changes in amyloid levels relate to symptom changes over time. Participants will undergo imaging with three different compounds—F-18 FDG, Pittsburgh Compound B (C-11 PiB), and Tau (18-F-AV-1451)—to provide a comprehensive view of brain changes. Ideal candidates are those already participating in certain Mayo Clinic neurological studies. As a Phase 4 trial, the treatment has FDA approval and proven effectiveness, helping researchers understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that the substances F-18 FDG, Pittsburgh Compound B, and Tau (18-F-AV-1451) used in PET scans are generally safe for people.

Studies on F-18 FDG have found it to be an effective and well-tolerated diagnostic tool. It is commonly used to assess symptoms related to Alzheimer's and other conditions, with side effects being rare and usually mild.

Pittsburgh Compound B (C-11 PiB) is another substance used in PET scans. Research has explored its role in diagnosing Alzheimer's disease, indicating it is safe as it can cross the protective layer around the brain without major issues.

Tau (18-F-AV-1451) helps image tau proteins in the brain, which are linked to Alzheimer's disease. Research suggests it is a useful biological marker for the condition and is well-tolerated, with no significant adverse effects reported.

These imaging substances are used in many diagnostic settings and have a good safety record based on available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Alzheimer's disease because they focus on advanced imaging techniques that can provide a clearer picture of what's happening in the brain. Unlike standard treatments that primarily manage symptoms, these imaging agents—F-18 FDG, Pittsburgh Compound B (C-11 PiB), and Tau (18-F-AV-1451)—help visualize the buildup of amyloid plaques and tau tangles, which are hallmarks of Alzheimer's. This approach could lead to earlier and more accurate diagnosis, potentially paving the way for more targeted and effective treatments in the future.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

This trial will use various brain imaging techniques to enhance the understanding and diagnosis of Alzheimer's disease. Participants will undergo PiB PET, FDG PET, and Tau PET scans. Research has shown that F-18 FDG PET scans can reliably rule out the progression to dementia in many cases. Pittsburgh Compound B (C-11 PiB) PET scans detect amyloid buildup, a key sign of Alzheimer's, by showing increased levels in affected brain areas. Studies indicate that PiB PET scans are linked to the progression from early to more noticeable stages of Alzheimer's. Tau PET scans with 18-F-AV-1451 reveal increases in tau protein deposits, another important sign of Alzheimer's. Together, these imaging techniques provide a comprehensive approach to diagnosing and understanding Alzheimer's disease. ^{3 5 6 7 8}

Who Is on the Research Team?

Val Lowe, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people aged 30-100 with various forms of dementia, including Alzheimer's and Lewy Body Disease, who are part of the Mayo Clinic aging or neurodegenerative studies. It excludes pregnant or breastfeeding women, those unable to lie still for scans, claustrophobic individuals, and anyone with MRI safety risks like pacemakers.

Inclusion Criteria

You have already had or are planning to have neurological tests at the Mayo Clinic.

I am between 30 and 100 years old.

Exclusion Criteria

Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

I cannot stay still lying down for 10 minutes.

I am not pregnant and can stop breastfeeding for 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PiB PET imaging to assess amyloid burden in the brain

1-2 weeks

Follow-up

Participants are monitored for changes in amyloid burden and clinical status over time

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• F-18 FDG
• Pittsburgh Compound B (C-11 PiB)
• Tau (18-F-AV-1451)

Trial Overview The study tests imaging agents (Pittsburgh Compound B, F-18 FDG, Tau) using PET scans to track amyloid plaque buildup in the brain over time and its link to changes in clinical status among aging individuals.

How Is the Trial Designed?

Group I: PiB PET, FDG PET, Tau PET Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Current PET imaging techniques, particularly 18-fluorodeoxyglucose (FDG-PET), effectively measure brain metabolism and neuronal function in Alzheimer's disease, revealing distinct patterns of hypometabolism even before dementia symptoms appear.

While FDG-PET is widely used, novel PET approaches for imaging amyloid-beta plaques are already in clinical use, and efforts to develop tau imaging are ongoing, though challenges remain due to the nature of tau protein deposition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging Brain Metabolism and Pathology in Alzheimer's Disease with Positron Emission Tomography. Shokouhi, S., Claassen, D., Riddle, W.[2020]

Pittsburgh compound-B (PiB) is a highly validated PET imaging tracer that specifically binds to fibrillar β-amyloid deposits in the brain, making it a reliable marker for detecting early amyloid deposition associated with dementia.

PiB-PET imaging can identify healthy individuals and those with mild cognitive impairment who are at high risk for developing Alzheimer's disease, potentially allowing for early intervention and preventive measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular neuroimaging in Alzheimer's disease. Matsuda, H., Imabayashi, E.[2016]

The new (18)F-labeled Aβ tracer, (18)F-AZD4694, shows similar binding kinetics and imaging characteristics to the established (11)C-PiB tracer, making it a promising alternative for detecting β-amyloid plaques in Alzheimer's disease.

Both tracers demonstrated low nonspecific white matter binding and high cortical binding, indicating that (18)F-AZD4694 is effective for accurate imaging in both clinical and research settings, with excellent correlation in results between the two tracers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of 11C-PiB and 18F-AZD4694 (NAV4694) for β-amyloid imaging in aging and dementia. Rowe, CC., Pejoska, S., Mulligan, RS., et al.[2021]

The first fully automated synthesis of the radiotracer [11C]PIB for imaging amyloid plaques in Alzheimer's disease was successfully developed, allowing for efficient production in clinical settings.

This automated process yields [11C]PIB with a high radiochemical purity of over 99% and a specific activity of 20-60 GBq/micromol, enabling timely preparation for PET scans within 25 minutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated radiosynthesis of the Pittsburg compound-B using a commercial synthesizer. Verdurand, M., Bort, G., Tadino, V., et al.[2020]

In a study involving 30 participants (11 with semantic dementia, 9 with Alzheimer's disease, and 10 healthy controls), only a minority of early-onset semantic dementia patients showed amyloid-β deposition, while late-onset semantic dementia patients were PIB-negative, suggesting a lack of Aβ accumulation in this group.

The findings indicate that amyloid-β deposition is not associated with late-onset semantic dementia, and while some early-onset patients may exhibit Aβ deposition, they do not present the typical memory or visuospatial deficits seen in Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amyloid deposition in semantic dementia: a positron emission tomography study. Brown, EE., Graff-Guerrero, A., Houle, S., et al.[2021]

In a phase 1b trial involving 278 patients with early stages of Alzheimer's disease, amyloid PET imaging successfully identified 61% of patients as amyloid-positive, making it a promising tool for selecting participants for clinical trials.

The study found that ApoE ε4 carriers were more likely to be amyloid-positive (80%) compared to noncarriers (43%), highlighting the potential of PET imaging to enrich trial populations based on genetic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amyloid PET Screening for Enrichment of Early-Stage Alzheimer Disease Clinical Trials: Experience in a Phase 1b Clinical Trial. Sevigny, J., Suhy, J., Chiao, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320856/

18F-FDG PET can effectively rule out conversion to dementia ... Using the NAB data as a reference, the brain 18F-FDG PET scans had an NPV of 81% in diagnosing neurodegenerative disease (91% for AD); when the ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/63/Supplement_1/2S

18F-FDG PET Imaging in Neurodegenerative Dementing ... 18 F-FDG PET is a relatively low cost and widely available imaging modality that can help assess various neurodegenerative disorders in a single test.

3. nature.com nature.com/articles/s41598-025-00183-3

18 F - -FDG PET imaging based on a state space model This model outperforms current state-of-the-art methods in predicting Alzheimer's using brain -FDG PET (fluorodeoxyglucose positron emission tomography) images.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0001299825000571

18 F-FDG PET for Dementia Evaluation: Co-pathologies ... This article reviews the roles of brain FDG PET, one of the well-established imaging biomarkers, as a valuable tool for studying brain metabolism.

5. link.springer.com link.springer.com/article/10.1007/s13139-025-00932-2

18 F-FDG-PET and Multimodal Biomarker Integration The study underscores the potential of integrating 18 F-FDG-PET with CSF biomarkers to enhance the diagnosis, prognosis, and monitoring of AD.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22173840/

Effectiveness and safety of 18F-FDG PET in the evaluation ... These data support the role of (18)F-FDG PET as an effective and useful adjunct to other diagnostic information in the assessment of patients with symptoms of ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/53/1/59

Effectiveness and Safety of 18F-FDG PET in the Evaluation of ... This study reported an 18F-FDG PET diagnostic sensitivity of 44% for the diagnosis of purely defined AD, with a specificity of 83%, whereas the ...

8. med.emory.edu med.emory.edu/departments/radiology/clinical_divisions/nuclear-medicine/documents/2020/neuro/effectiveness-and-safety-of-fdg-pet-in-the-evaluation-of-dementia--a-review-of-the-recent-literature.pdf

Effectiveness and Safety of 18F-FDG PET in the Evaluation ... Functional neuroimaging data were obtained, and nuclear medicine physicians who were not aware of the clinical diagnosis generated 18F-FDG PET.