Longitudinal Imaging Biomarkers of Disease Progression in DLB

NCT03582488 | Enrolling By Invitation Phase 4 FDA Drug

• 2 other identifiers: 17-011339U01NS100620
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lewy Body Disease

Outcome Measures

Primary Outcomes (1)

• Rate of change in 18F-Flortaucipir PET imaging and Pittsburgh compound-B PET imaging

  Cortical 18F-Flortaucipir and Global cortical Pittsburgh compound-B uptake will be measured in each participant over three years

  Will be assessed 3 times annually over at least three years

Study Arms (1)

Dementia with Lewy Bodies

EXPERIMENTAL

18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology

Drug: 18F-Flortaucipir

Interventions

18F-Flortaucipir DRUG

Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology

Also known as: 11C- Pittsburgh Compound-B

Dementia with Lewy Bodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of probable DLB, at least 18 years of age, 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, willing and able to undergo neuropsychological testing and no contraindication to MRI imaging.

You may not qualify if:

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

Sponsors & Collaborators

• Kejal Kantarci: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lewy Body Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kejal Kantarci, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 11, 2018
• Study Start: June 25, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)