Flortaucipir Imaging for Lewy Body Disease

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the link between certain brain changes and memory and thinking issues in people with Dementia with Lewy bodies (DLB). The study uses a special imaging method with 18F-Flortaucipir, a radioactive tracer used in PET scans, to examine brain proteins that might affect cognitive decline. It is suitable for those diagnosed with DLB who have regular interaction with someone and can commit to multiple visits over five years. Participants should be comfortable with tests such as MRI scans and memory assessments. This research seeks to shed light on the progression of DLB and how it might be better managed in the future. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits 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 18F-Flortaucipir?

Research has shown that 18F-Flortaucipir is generally safe for humans. This imaging agent helps identify tau protein build-up, which is linked to Alzheimer's and Dementia with Lewy bodies (DLB).

One study found that 18F-Flortaucipir accurately distinguishes Alzheimer's from other brain diseases, with nearly 90% accuracy in identifying those with the disease and over 90% in identifying those without it. This indicates the treatment is reliable and safe for its purpose.

As a Phase 4 trial, the treatment has already passed earlier safety tests and is now being studied in more people to learn more about its effects. Overall, current findings suggest few safety concerns, but discussing any potential risks with the study team is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Lewy Body Disease, which primarily focus on managing symptoms with medications like cholinesterase inhibitors and antipsychotics, 18F-Flortaucipir offers a new approach by providing advanced imaging capabilities. Researchers are excited because this imaging agent targets beta-amyloid and neurofibrillary tau pathology in the brain, which are key markers of neurodegenerative diseases. This could lead to more accurate diagnoses and a better understanding of disease progression, ultimately improving patient care and treatment strategies.

What evidence suggests that 18F-Flortaucipir is effective for imaging biomarkers in Dementia with Lewy bodies?

Research has shown that 18F-Flortaucipir effectively detects tau protein build-up, which is linked to various types of dementia. One study demonstrated that this imaging method can accurately distinguish between patients with high and low tau levels. The U.S. Food and Drug Administration approved 18F-Flortaucipir because it binds to tau, aiding in diagnosing conditions like Alzheimer's disease. In this trial, participants with dementia with Lewy bodies (DLB) will undergo experimental PET imaging using 18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands. Studies have found little tau build-up in DLB compared to healthy individuals, suggesting that while 18F-Flortaucipir is effective for detecting tau, its primary use in DLB might be to help differentiate it from other dementias. ^{2 4 5 6 7}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37748892/

Performance of a [18F]Flortaucipir PET Visual Read ... This study provides Class II evidence that [ 18 F]flortaucipir visual read accurately distinguishes patients with low tau-tracer binding from those with high ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10663007/

Performance of a [18F]Flortaucipir PET Visual Read ... Recently, the US Food and Drug Administration approved the tau-binding radiotracer [18F]flortaucipir and an accompanying visual read method to support the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0197458020303882

Imaging tau burden in dementia with Lewy bodies using [18F] We evaluated [18F]-AV1451 uptake in dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). There is minimal tau deposition in DLB compared to healthy ...

4. academic.oup.com academic.oup.com/braincomms/article/6/1/fcad305/7424837

A review of the flortaucipir literature for positron emission ... In this review, we present an overview of the published literature on flortaucipir for positron emission tomography imaging of neurofibrillary tau tangles.

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8209140/

Imaging tau burden in dementia with Lewy bodies using [18F] Here, we evaluated the in vivo distribution of tau burden and its influence on the clinical phenotype of DLB.

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702872

Discriminative Accuracy of [ 18 F]flortaucipir Positron ... The use of [ 18 F]flortaucipir PET had an estimated sensitivity of 89.9% and specificity of 90.6% for Alzheimer disease vs other neurodegenerative diseases.