Clinical trial NCT03582488: Longitudinal Imaging Biomarkers of Disease Progression in DLB
Official title: Longitudinal Imaging Biomarkers of Disease Progression in DLB
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Lewy Body Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2018-07-11
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of change in 18F-Flortaucipir PET imaging and Pittsburgh compound-B PET imaging
timeFrame: Will be assessed 3 times annually over at least three years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kejal Kantarci, MD
role: PRINCIPAL_INVESTIGATOR
References: