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

8000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a special brain scan to see harmful buildups in the brain. It targets both healthy people and those with brain diseases to understand how well the scan works.

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 data supports the effectiveness of the treatment F-18 FDG, Pittsburgh Compound B (C-11 PiB), Tau (18-F-AV-1451) for Alzheimer's Disease?

The research shows that amyloid PET imaging, which includes Pittsburgh Compound B (C-11 PiB), is effective in identifying amyloid plaques, a key feature of Alzheimer's disease, and helps in distinguishing Alzheimer's from other types of dementia. Additionally, F-18 FDG PET is widely used to measure brain metabolism and can detect changes in brain activity associated with Alzheimer's, even before symptoms appear. ^{1 2 3 4 5}

Is brain amyloid imaging for Alzheimer's disease safe for humans?

The Pittsburgh compound-B (PiB) used in brain amyloid imaging for Alzheimer's disease has been extensively studied and is considered safe for human use in clinical settings. It is a radiotracer that helps visualize amyloid plaques in the brain, and while it involves exposure to low levels of radiation, it is generally well-tolerated. ^{4 6 7 8 9}

How does brain amyloid imaging differ from other Alzheimer's treatments?

Brain amyloid imaging, using techniques like Pittsburgh Compound-B (PIB) PET scans, is unique because it allows doctors to see amyloid plaques in the brain of living patients, which are a hallmark of Alzheimer's disease. This imaging method provides a way to assess the presence and distribution of amyloid deposits, unlike other treatments that focus on managing symptoms or slowing disease progression. ^{2 4 10 11 12}

Research Team

Val Lowe, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Amyloid Positron Emission Tomography in the Therapeutic Strategies for Alzheimer's Disease]. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Imaging Brain Metabolism and Pathology in Alzheimer's Disease with Positron Emission Tomography. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Amyloid imaging in the differential diagnosis of dementia: review and potential clinical applications. [2021]

4. England pubmed.ncbi.nlm.nih.gov

PET imaging of brain amyloid in dementia: a review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Amyloid PET Screening for Enrichment of Early-Stage Alzheimer Disease Clinical Trials: Experience in a Phase 1b Clinical Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Automated radiosynthesis of the Pittsburg compound-B using a commercial synthesizer. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Molecular neuroimaging in Alzheimer's disease. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of 11C-PiB and 18F-AZD4694 (NAV4694) for β-amyloid imaging in aging and dementia. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Amyloid deposition in semantic dementia: a positron emission tomography study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Tau PET in Alzheimer disease and mild cognitive impairment. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Tau, amyloid, and hypometabolism in a patient with posterior cortical atrophy. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Imaging brain amyloid in Alzheimer's disease with Pittsburgh Compound-B. [2022]