60 Participants Needed

Molecular and Structural Imaging for Alzheimer's Disease

SM
Overseen BySarah M Boland, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you may be excluded if you are on medications that affect brain structure or metabolism, like chemotherapy.

What data supports the effectiveness of the drug C-11 PiB, Pittsburgh Compound B, [11C]6-OH-BTA-1, (N-Methyl-[11C])2-(4'-methylamino-phenyl)-6-hydroxy-benzo-thiazole, [11C]PiB, F-18 AV 1451, Tauvid, Flortaucipir F-18, 18F-AV-1451, 18F-T807, LY-3191748, T-807 F-18 for Alzheimer's disease?

Research shows that Flortaucipir F-18, a component of the drug, is effective in imaging tau protein tangles, which are a key feature of Alzheimer's disease. This helps in diagnosing and understanding the progression of the disease by showing the distribution and density of these tangles in the brain.12345

Is the imaging treatment for Alzheimer's disease safe for humans?

The imaging agents like Pittsburgh compound B and flortaucipir have been used in many studies for Alzheimer's disease and other conditions, and they are generally considered safe for human use in clinical settings.678910

How does the treatment in the Alzheimer's imaging trial differ from other treatments?

This treatment uses advanced imaging techniques like PET scans with specific tracers to visualize and measure amyloid and tau proteins in the brain, which are associated with Alzheimer's disease. Unlike traditional treatments that focus on symptom management, this approach aims to provide a detailed understanding of the disease's progression and response to potential therapies.18101112

What is the purpose of this trial?

This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.

Research Team

JW

Jennifer Whitwell, Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This study is for adults over 21 with Atypical Alzheimer's Disease, specifically those diagnosed with Logopenic Aphasia or Posterior Cortical Atrophy. Participants must have a person to report on their functioning and speak English as their primary language. They can't join if they've had strokes, tumors, severe memory issues early on, other neurodegenerative diseases, very poor vision, are pregnant/breastfeeding, or have MRI contraindications.

Inclusion Criteria

I have trouble finding the right words and forming sentences.
I have Alzheimer's with worsening memory loss or specific symptoms like LPA or PCA.
English is primary language
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Exclusion Criteria

I do not have any other neurodegenerative disorders like frontotemporal dementia.
Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy)
I have had a stroke or tumor that might be causing my symptoms.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo two Tau PET scans and two PiB PET scans to assess amyloid and tau burden

12 months

Follow-up

Participants are monitored for changes in amyloid and tau burden over a one year period

4 weeks

Treatment Details

Interventions

  • C-11 PiB
  • F-18 AV 1451
Trial Overview The trial is using advanced brain imaging techniques (F-18 AV 1451 and C-11 PiB) to investigate the presence of amyloid and tau proteins in patients' brains. It aims to see how these protein levels change over one year in individuals with atypical forms of Alzheimer's disease.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Tau PET Scan, F-18 AV 1451Experimental Treatment2 Interventions
All subjects will receive two Tau PET scans during this study.
Group II: PiB PET Scan, C-11 PiBExperimental Treatment2 Interventions
All subjects will receive two PiB PET scans during this study.

Find a Clinic Near You

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

This study found a strong correlation (Pearson r = 0.81) between flortaucipir PET imaging results and levels of abnormally phosphorylated tau (Ptau) in brain tissue from patients with dementia, suggesting that flortaucipir can effectively reflect tau pathology in Alzheimer's disease.
The research indicates that while flortaucipir PET correlates well with Ptau levels, it does not show a significant relationship with amyloid-β (Aβ1-42), highlighting its potential specificity for tau-related changes in the brain.
Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study.Pontecorvo, MJ., Keene, CD., Beach, TG., et al.[2021]
18F-Florbetapir PET imaging is effective for detecting β-amyloid plaques, while 18F-Flortaucipir PET is useful for visualizing tau protein tangles, both of which are critical for diagnosing Alzheimer's disease (AD).
Combining data from both amyloid and tau PET scans can enhance the accuracy of differential diagnosis and prognosis in patients with mild cognitive impairment or suspected AD.
Evaluating Alzheimer Disease With Flortaucipir and Florbetapir PET: A Clinical Case Series.James, OG., Linares, AR., Hellegers, C., et al.[2023]
The [18F]flortaucipir PET imaging technique has demonstrated high affinity for tau proteins associated with Alzheimer's disease and shows excellent accuracy in distinguishing AD from other conditions, indicating strong analytical and clinical validity.
While phases 1 and 2 of the maturity assessment for [18F]flortaucipir PET have been largely achieved, further research is needed to fully establish its clinical utility, particularly in early detection and healthcare outcomes for patients with mild cognitive impairment.
Clinical validity of increased cortical uptake of [18F]flortaucipir on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase biomarker development framework.Wolters, EE., Dodich, A., Boccardi, M., et al.[2021]

References

Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study. [2021]
Evaluating Alzheimer Disease With Flortaucipir and Florbetapir PET: A Clinical Case Series. [2023]
Clinical validity of increased cortical uptake of [18F]flortaucipir on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase biomarker development framework. [2021]
Comparative assessment of regional tau distribution by Tau-PET and Post-mortem neuropathology in a representative set of Alzheimer's & frontotemporal lobar degeneration patients. [2023]
The Sensitivity of Tau Tracers for the Discrimination of Alzheimer's Disease Patients and Healthy Controls by PET. [2023]
International consensus on the use of tau PET imaging agent 18F-flortaucipir in Alzheimer's disease. [2022]
Automated radiosynthesis of the Pittsburg compound-B using a commercial synthesizer. [2020]
Amyloid-β imaging with Pittsburgh compound B and florbetapir: comparing radiotracers and quantification methods. [2022]
Tau PET Imaging with [18F]PM-PBB3 in Frontotemporal Dementia with MAPT Mutation. [2021]
Amyloid deposition in semantic dementia: a positron emission tomography study. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Voxel-based analysis of PET amyloid ligand [11C]PIB uptake in Alzheimer disease. [2020]
11C-PiB PET assessment of change in fibrillar amyloid-beta load in patients with Alzheimer's disease treated with bapineuzumab: a phase 2, double-blind, placebo-controlled, ascending-dose study. [2021]
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