Longitudinal Imaging Biomarkers of Disease Progression in DLB

Sponsor

Kejal Kantarci (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03582488

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Locations

Arm

65.2

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jun 25, 2018

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 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 Names: 11C- Pittsburgh Compound-B

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 Names:

11C- Pittsburgh Compound-B

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224
2	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Kejal Kantarci, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03582488

Other Study ID Numbers:

17-011339
U01NS100620

First Posted:

Jul 11, 2018

Last Update Posted:

Dec 9, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lewy Body Disease

Disease Progression

Corticosterone

Study Results

No Results Posted as of Dec 9, 2021