Flortaucipir Imaging for Lewy Body Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kejal Kantarci

Disqualifiers: Multiple sclerosis, Brain tumors, 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: 7

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Researchers are trying to determine the paths of change in imaging biomarkers of Dementia with Lewy bodies (DLB) and their associations with rate of cognitive and functional decline.

Will I have to stop taking my current medications?

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

Is 18F-Flortaucipir safe for use in humans?

18F-Flortaucipir has been used in studies for Alzheimer's disease and Lewy body disorders, and while it is primarily used to detect tau protein in the brain, there is no specific mention of safety concerns in the provided research articles. However, it is important to consult with healthcare professionals for personalized advice. ^{1 2 3 4 5}

How does the drug Flortaucipir differ from other treatments for Lewy Body Disease?

Flortaucipir is unique because it is a radiotracer used in PET scans to detect tau protein build-up in the brain, which is associated with cognitive impairment in Lewy Body Disease. Unlike other treatments that may focus on symptom management, Flortaucipir helps in diagnosing and understanding the extent of tau pathology, providing a more precise assessment of the disease. ^{1 2 4 6 7}

What data supports the effectiveness of the drug 18F-Flortaucipir for Lewy Body Disease?

Research shows that 18F-Flortaucipir, a drug used in brain imaging, can help identify tau protein build-up in patients with Lewy Body Disease. This build-up is linked to cognitive problems, suggesting the drug may be useful in diagnosing and understanding the disease. ^{1 2 4 8 9}

Who Is on the Research Team?

Kejal Kantarci, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with probable Dementia with Lewy bodies (DLB). Participants need an informant who checks on them weekly, must speak English well, consent to the study's protocol, and be able to attend up to six visits over five years. They should not have other neurological disorders like multiple sclerosis or brain tumors that could affect results.

Inclusion Criteria

Reliable informant who personally speaks with or sees the participant at least weekly

Sufficiently fluent in English

Must be willing and able to consent to the protocol and undergo up to 6 visits over 5 years

Exclusion Criteria

Unwilling to return for follow-up yearly and undergo neuropsychological testing and MR imaging

Do not have a reliable informant

You have another neurological disorder, like multiple sclerosis or a brain tumor, that could affect the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including clinical and biospecimen data collection, and baseline imaging

1 visit

1 visit (in-person)

Follow-up Assessments

Participants undergo clinical and biospecimen data collection, and neuroimaging assessments

5 years

6 visits (in-person) over 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Flortaucipir

Trial Overview The study aims to track changes in imaging biomarkers related to DLB using a technique called 18F-Flortaucipir PET scanning. It will explore how these changes correlate with cognitive and functional decline in participants over time.

How Is the Trial Designed?

Group I: Dementia with Lewy Bodies Experimental Treatment 1 Intervention

18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology

Who Is Running the Clinical Trial?

Kejal Kantarci

Lead Sponsor

Trials

1

Recruited

140+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study involving 33 patients with progressive supranuclear palsy (PSP), 18 F-flortaucipir showed significantly elevated uptake in specific brain regions compared to normal controls (46 participants) and patients with Parkinson disease (26 participants), indicating its potential as a biomarker for tau pathology in PSP.

The globus pallidus region was particularly effective in distinguishing PSP patients from both controls and Parkinson disease patients, with high accuracy (AUC values of 0.872 and 0.893, respectively), suggesting that 18 F-flortaucipir could aid in the diagnosis of PSP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18 F-flortaucipir tau positron emission tomography distinguishes established progressive supranuclear palsy from controls and Parkinson disease: A multicenter study. Schonhaut, DR., McMillan, CT., Spina, S., et al.[2022]

Citations

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

New Tracers and New Perspectives for Molecular Imaging in Lewy Body Diseases. [2018]

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

Performance of a [18F]Flortaucipir PET Visual Read Method Across the Alzheimer Disease Continuum and in Dementia With Lewy Bodies. [2023]

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

Multimodal in vivo and postmortem assessments of tau in Lewy body disorders. [2022]

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

Toward imaging of alpha-synuclein with PET. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Tau PET and relative cerebral blood flow in dementia with Lewy bodies: A PET study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Tau Tangles in Parkinson's Disease: A 2-Year Follow-Up Flortaucipir PET Study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

18F-AV-1451 in Parkinson's Disease with and without dementia and in Dementia with Lewy Bodies. [2022]

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

18 F-flortaucipir tau positron emission tomography distinguishes established progressive supranuclear palsy from controls and Parkinson disease: A multicenter study. [2022]

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

Complementary role of 18F-FDG PET and 123I-ioflupane SPECT in the diagnosis of Lewy body disease. [2017]