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Flortaucipir Imaging for Lewy Body Disease

Phase 4
Waitlist Available
Led By Kejal Kantarci, MD
Research Sponsored by Kejal Kantarci
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of probable DLB
No contraindication to MRI imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be assessed 3 times annually over at least three years
Awards & highlights

Study Summary

This trial is looking at how quickly people with Dementia with Lewy bodies (DLB) decline and what affects this decline.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the document does not specify side effects of 18F-Flortaucipir, typical PET scan risks may include discomfort at injection site, allergic reaction to tracer substance, and exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with probable dementia with Lewy bodies.
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You are not unable to have an MRI scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be assessed 3 times annually over at least three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be assessed 3 times annually over at least three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of change in 18F-Flortaucipir PET imaging and Pittsburgh compound-B PET imaging

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dementia with Lewy BodiesExperimental Treatment1 Intervention
18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,335 Previous Clinical Trials
648,396 Total Patients Enrolled
2 Trials studying Lewy Body Disease
750 Patients Enrolled for Lewy Body Disease
Kejal KantarciLead Sponsor
Kejal Kantarci, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

18F-Flortaucipir Clinical Trial Eligibility Overview. Trial Name: NCT03582488 — Phase 4
Lewy Body Disease Research Study Groups: Dementia with Lewy Bodies
Lewy Body Disease Clinical Trial 2023: 18F-Flortaucipir Highlights & Side Effects. Trial Name: NCT03582488 — Phase 4
18F-Flortaucipir 2023 Treatment Timeline for Medical Study. Trial Name: NCT03582488 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new applicants currently being considered for this clinical trial?

"The data hosted on clinicaltrials.gov displays that this trial is no longer accepting patients, as it was first posted in the 25th of June 2018 and last updated on December 1st 2022. Nevertheless, 121 other trials are presently open for recruitment."

Answered by AI

How many participants can take part in this experiment?

"Unfortunately, recruitment for this study is currently suspended. First posted on June 25th 2018 and last modified December 1st 2022, those hoping to participate need to seek alternative studies at the moment. Currently, 116 trials are enrolling patients with Lewy Body Disease while 5 separate studies require 18F-Flortaucipir participants."

Answered by AI

Could you detail other investigations involving 18F-Flortaucipir?

"18F-Flortaucipir was initially investigated in 2008 at the Mayo Clinic. Since then, 7 trials have been successfully conducted and 5 more are currently underway across many locations based primarily around Rochester, Minnesota."

Answered by AI

To what extent can 18F-Flortaucipir prove detrimental to individuals?

"With Phase 4 trial results backing it, 18F-Flortaucipir has earned a safety ranking of 3 on the Power scale."

Answered by AI
~50 spots leftby Sep 2027