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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ will be assessed 3 times annually over at least three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be assessed 3 times annually over at least three years
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
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Who is running the clinical trial?
Kejal KantarciLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,553 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another neurological disorder, like multiple sclerosis or a brain tumor, that could affect the study results.If having a Tau imaging test, you cannot have a prolonged QT interval on your heart's electrical activity.You have been diagnosed with probable dementia with Lewy bodies.You are not unable to have an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Dementia with Lewy Bodies
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.