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1. Arizona Alzheimer’s Disease Research Center (ADRC-001)

   Scottsdale/Phoenix, Ariz.

   There is evidence that neurodegenerative changes precede clinical symptoms in Alzheimer’s disease by two decades (Villemagne et al, 2013). Early detection is critical for development of interventions to halt, slow, or even reverse these pathological processes. The promise of plasma biomarkers to identify early pathology is growing rapidly (Palmqvist et al, 2020), however it is likely that multiple converging biomarkers will be necessary to identify the earliest pathological changes, as subtle differences from healthy controls may fall within the margin of error for any given single biomarker measure. Here we propose that the evaluation of speech and language for both baseline (cross-sectional) and longitudinal changes (within-participant) may add significant value to early pre-clinical pathological changes in MCI and AD. This is bolstered by emerging evidence of the relationship between language characteristics and amyloid burden (Verfaillie et al, 2019) and the large literature that characterizes language-use differences and deficits across the spectrum of cognitive decline (e.g., Mueller et al, 2018). We propose to add a series of in-clinic language elicitation tasks that allow for automated assessment of relevant speech and language domains and to validate these measures cross-sectionally and longitudinally relevant to neuropsychological, blood, and PET biomarkers.

2. A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma

   Rochester, Minn.

   The pupose of this study is to evaluate whether or not selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.

3. A Study to Evaluate Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer

   Jacksonville, Fla.

   The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.

4. Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

   Rochester, Minn.

   The purpose of this study is to determine and compare the safety and efficacy of transcutaneous afferent patterned stimulation (TAPS) and respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) therapies for the reduction of paroxysmal atrial fibrillation (AF) burden.

5. A Study to Evaluate Sex and Gender in Multiple System Atrophy

   Rochester, Minn.

   The primary purpose of this study is to understand the influence of sex and gender on pathophysiologic mechanisms of neurodegeneration in Multiple System Atrophy (MSA) in order to determine sex-specific hormonal factors associated with onset of symptoms in MSA.

6. Multiscale EEG Dynamics

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose if this study  to combine state of the art cerebral signal processing techniques and localization methods with intracranial electrode recordings to investigate the interaction of local hippocampal and neocortical networks with distributed brain activity.

7. Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases

   Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Rochester, Minn., Albert Lea, Minn.

   This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.

8. Advanced Care Planning in Dementia

   Jacksonville, Fla.

   The goal of this study is to gain a better understanding of the status of advanced care planning among caregivers of patients with dementia and examine how this differs by race and disease stage.

9. Blood and Spinal Fluid Collection for Research Studies in Motor Neuron Disease and Motor Neuropathy

   Rochester, Minn.

   The purpose of this study is so that blood (plasma and blood cells) and/or extra spinal fluid (which was taken for clinical purposes) can be obtained and stored for later research on a large cohort of patients with progressive motor neuronopathies and neuropathies, many of which will be determined to suffer from Amyotrophic Lateral Sclerosis (ALS). 

10. A Study to Explore if it is Possible to Successfully Obtain Optical Coherence Tomography (OCT) Imaging and Data While Patients Undergo Brain Surgery

    Jacksonville, Fla.

    The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.