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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be assessed 3 times annually over at least three years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

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

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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?

Kejal KantarciLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,702 Total Patients Enrolled
2 Trials studying Lewy Body Disease
750 Patients Enrolled for Lewy Body Disease
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
~40 spots leftby Sep 2027
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