LEADS –
Longitudinal Early-Onset Alzheimer’s Disease Study
Role: Recruiting site (Active); Visual reads and analyze
Summary: The Longitudinal Early-Onset Alzheimer’s Disease Study (LEADS) will explore the development of early-onset Alzheimer’s disease and how it compares to the more common late-onset Alzheimer’s variant. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed.
Goal: The primary goal of LEADS is to develop sensitive clinical and biomarker measures for future clinical and research use.
Link: https://leads-study.medicine.iu.edu
New IDEAS:
Imaging Dementia–Evidence for Amyloid Scanning
Role: Recruiting site (Complete)
Summary: The New IDEAS (Active): Imaging Dementia—Evidence for Amyloid Scanning Study is a novel Coverage with Evidence Development Study that will build upon the results from the original IDEAS Study. A major limitation of the original IDEAS cohort was the lack of racial and ethnic diversity, with 88% of participants identifying as non-Hispanic White/Caucasian. The New IDEAS Study will concentrate on the recruitment of Black/African American and Latinx/Hispanic participants to address this limitation. Moreover, New IDEAS will also add saliva collection for genotyping of ApoE, blood collection to establish a biorepository of plasma and DNA samples, and archiving of PET images for use in future studies.
Goal: The overarching goal of New IDEAS is to evaluate the clinical utility of beta-amyloid PET in a broad, diverse population of cognitively impaired individuals.
Link: https://www.ideas-study.org/About-Us
IDEAS
(Imaging Dementia–Evidence for Amyloid Scanning)
Role: Recruiting site (Complete); quantify MRI-free heterogeneous amyloid scans acquired at clinical sites
Summary: The original IDEAS Study was developed in response to the 2013 Centers for Medicare and Medicaid Services (CMS) National Coverage Decision on amyloid PET imaging in dementia and neurodegenerative disease. CMS questioned the ability of PET amyloid imaging to lead to improved health outcomes, such as avoidance of futile treatment or tests, improving quality of life or slowing its decline, and survival.
Goal: The overarching goal of IDEAS was to evaluate the clinical utility of beta-amyloid PET in cognitively impaired individuals, with the primary endpoint being change in clinical management. Specifically, the goal was to determine if amyloid PET is associated with a ≥30% change in composite patient management endpoint between the pre-PET and post-PET visit, separately in MCI and dementia.
Link: https://www.ideas-study.org/Original-Study
TANGLE
Tau Agent for the NeurodeGenerative lesion of CTE
Role: Quantify tau uptake in former american football players and descriptive visual reads
Summary: The Tau Agent for the NeurodeGenerative lesion of CTE (TANGLE) study is a collaborative effort between BU and UCSF to evaluate if 18F-PI-2620, an investigational radiotracer that binds to tau neurofibrillary tangles and initially designed to bind to neurofibrillary tangle pathology in Alzheimer's disease (AD), can also be used as a biomarker of abnormal tau accumulation and brain changes in patients with suspected CTE.
Goal: The goal of this pilot study is to compare 18F-PI-2620 tracer retention in former American football players and controls to see if this retention correlates with worse cognitive and neuropsychiatric function and greater exposure to RHI.
Link: https://www.bu.edu/cte/our-research/clinical-research-2/
SCAN
Role: Recruiting site (Active)
Summary: ADRC-SCAN: Investigating PI-2620, a Novel Tau Tracer is a research study that aims to examine whether a new brain imaging agent (PI-2620) can be used in a Positron Emission Tomography (PET) scan to detect the tau protein type in the brain. The study team will compare brain images from PET scans in cognitively unimpaired adults and patients with MCI/AD and FTLD-Tau and FTLD-TDP.
Goal: The primary goal of ADRC-SCAN is to qualitatively characterize the [18F]PI-2620 binding patterns to see if the patterns are helpful in telling the difference between different types of progressive brain diseases.
Link: TBD
SAVE-HI
Role: Recruiting site
Summary: The Study of the Axonal and Vascular Effects from Repetitive Head Impacts (SAVE-HI) is a study to examine risk factors for, and the cognitive and neuropsychiatric effects of WM degeneration and CBVD in living and deceased male and female former contact sport athletes across different sports.
Goal: The objective of this study is to examine if repetitive impacts from playing contact sports has long-term effects on the white matter and vascular system of the brain.
Link: https://www.bu.edu/cte/our-research/clinical-research-2/
HEAD to HEAD
Role: Recruiting site (Active)
Summary: The Longitudinal multicenter head-to-head harmonization of tau PET tracers (HEAD Study) is a multi-site, observational, non-randomized study that will compare cross-sectional and longitudinal head-to-head tau PET scans using [18F]MK-6240 with [18F] Flortaucipir tracers. This study will enroll a combination of young controls, cognitively unimpaired elderly adults and patients with MCI/AD across eight clinical sites in the US and Canada.
Goal: Ideally, aid in the creation of CenTaurs (equivalent of Centiloids, but in Tau instead of Amyloid)
Link: https://classic.clinicaltrials.gov/ct2/show/NCT05361382
FIND-CTE
Role: Recruiting site (Complete); Quantify tau uptake in NFL cohort and descriptive visual reads (Complete)
Summary: The Focused Imaging for the Neurodegenerative Disease - Chronic Traumatic Encephalopathy (FIND-CTE) study is a collaborative effort between UCSF and BU to evaluate if 18F-MK-6240, an investigational radiotracer that binds to tau neurofibrillary tangles and initially designed to bind to neurofibrillary tangle pathology in Alzheimer's disease (AD), can also be used as a biomarker of abnormal tau accumulation and brain changes in patients with CTE.
Goal: The goal of this pilot study is to compare 18F-MK-6240 tracer retention in former NFL players and controls and to see if this retention correlates with worse cognitive and neuropsychiatric function and greater exposure to RHI.
Link: https://www.bu.edu/cte/our-research/clinical-studies/
DoD - ADBi
Role: Recruiting site (Active); quantification
Summary: We are doing this study to find accurate blood tests to diagnose Alzheimer’s disease (AD) in Veterans. Currently the only FDA-approved way to diagnose Alzheimer’s disease is with an amyloid PET scan or a lumbar puncture though there are some very promising blood tests currently being developed which would make this diagnosis more accessible. Veterans often have unique exposures that make them different from Civilians (like head trauma, blasts, post-traumatic stress disorder, chemicals, and other military exposures). The impact of these unique exposures on accuracy of emerging AD blood biomarkers is entirely unknown.
Goal: To compare amyloid PET scans (the current “gold standard” test) to blood test results to determine if these tests are indeed accurate for diagnosing Alzheimer’s disease in Veterans.
Link: TBD
Project: DeepNeuro
Role: Recruiting site (Active)
Summary: Within neurology and psychiatry, there is a unique opportunity to integrate research efforts to pursue our common goal of solving complex neurological problems. The underlying biology of various conditions is common. We are creating a database of phenotypic data which in our case will include blood samples and 3T/7T MRI data (which will be connected to diagnoses, age, gender, etc). We are also hoping to create synthetic MRIs for a shared neuroimaging infrastructure.
Goal: The Deep Neuro study is working to create a well-phenotyped cohort followed over a goal of 10 years with several neurological specialties. The goal is to enroll patients with Multiple Sclerosis and Alzheimer's Disease as well as healthy controls.
Link: TBD
