Longitudinal Imaging Biomarkers of Disease Progression in DLB

• ClinicalTrials.gov Identifier: NCT03582488
• Recruitment Status: Enrolling by invitation
• First Posted: July 11, 2018
• Last Update Posted: December 9, 2021
• Sponsor: Kejal Kantarci
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): Kejal Kantarci, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lewy Body Disease	Drug: 18F-Flortaucipir	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Longitudinal Imaging Biomarkers of Disease Progression in DLB
• Actual Study Start Date: June 25, 2018
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dementia with Lewy Bodies; 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; Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology; Other Name: 11C- Pittsburgh Compound-B

Outcome Measures

Primary Outcome Measures :

1. Rate of change in 18F-Flortaucipir PET imaging and Pittsburgh compound-B PET imaging [ Time Frame: Will be assessed 3 times annually over at least three years ]
   Cortical 18F-Flortaucipir and Global cortical Pittsburgh compound-B uptake will be measured in each participant over three years

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Florida

Mayo Clinic

Jacksonville, Florida, United States, 32224

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Kejal Kantarci

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Kejal Kantarci, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Kejal Kantarci, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03582488
• Other Study ID Numbers: 17-011339; U01NS100620 ( U.S. NIH Grant/Contract )
• First Posted: July 11, 2018
• Last Update Posted: December 9, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Lewy Body Disease; Disease Progression; Disease Attributes; Pathologic Processes; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Corticosterone; Anti-Inflammatory Agents