Longitudinal Imaging Biomarkers of Disease Progression in DLB

Last updated: March 17, 2026
Sponsor: Kejal Kantarci
Overall Status: Active - Enrolling

Phase

4

Condition

Lewy Body Dementia

Parkinson's Disease

Treatment

18F-Flortaucipir

Clinical Study ID

NCT03582488
17-011339
U01NS100620
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of probable DLB, at least 18 years of age, reliable informant whopersonally speaks with or sees the participant at least weekly, sufficiently fluentin English, must be willing and able to consent to the protocol and undergo up to 6visits over 5 years, willing and able to undergo neuropsychological testing and nocontraindication to MRI imaging.

Exclusion

Exclusion Criteria:

  • Presence of another neurologic disorder which could impact findings, such asmultiple sclerosis, brain tumors, etc., unwilling to return for follow-up yearly andundergo neuropsychological testing and MR imaging, if undergoing Tau imaging cannothave QT Prolongation, do not have a reliable informant.

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: 18F-Flortaucipir
Phase: 4
Study Start date:
June 25, 2018
Estimated Completion Date:
September 30, 2027

Study Description

The proposed project will enroll 90 subjects with probable DLB, 60 from Mayo Clinic Rochester (MCR) and 30 from Mayo Clinic Jacksonville (MCJ). Additionally, 45 controls will be enrolled, 30 from MCR and 15 from MCJ. We will obtain up to six assessments in each subject over the 5 years of the study, baseline, six month and annually thereafter. We will follow these cohorts with clinical and biospecimen data collection annually and once at six months, and CSF collection annually within the guidelines of the Parkinson's Disease Biomarker's Program (PDBP). Clinical neuroimaging will be performed annually and include: a) dopamine transporter imaging with Ioflupane (123I) SPECT (DaTscan) as the biomarker of LBD-related loss of dopaminergic activity, b) structural MRI AD- signature atrophy as the biomarker of AD-related neurodegeneration, c) β-amyloid (Aβ) deposition on PET as the biomarker of Aβ pathology. In patients from the MCR site, we will investigate AV-1451 PET. Since the specificity of AV-1451 PET is not established for tau deposition in DLB, we will investigate this biomarker in a subset of DLB patients to determine the pattern of AV-1451 uptake compared to clinically normal controls, and its association with atrophy, Aβ load and clinical disease progression in DLB.

Connect with a study center

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.