Neurología

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

   Rochester, Minn.

   The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up in different geographic populations.

2. Investigating the Genetic and Phenotypic Presentation of Ataxia and Nucleotide Repeat Diseases

   Jacksonville, Fla.

   The purpose of this study is to create a repository for cerebellar ataxia and nucleotide repeat diseases in order to fully investigate the genetic and phenotypic presentations of both.

3. ALSENLITE: Senolytics for Alzheimer's Disease

   Rochester, Minn.

   The purpose of this study is to measure target engagement in cerebrospinal fluid (CSF) and blood, and to establish the feasibility and safety of Dasatinib plus Quercetin treatment in adults with early stage but symptomatic Alzheimer's Disease (AD) to inform and select the best blood, CSF, urine, and other analyses to conduct in banked samples from a larger Phase 2b clinical trial.

4. A Study to Establish a Parkinson’s Disease (PD) Cohort using the Parkinson’s Progression Markers Initiative (PPMI)

   Scottsdale/Phoenix, Ariz.

   The Parkinson Progression Marker Initiative (PPMI) is a study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson’s disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

5. Primary Tumor Research and Outcome Network (PTRON) Registry

   Rochester, Minn.

   The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.

6. 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.

7. 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.

8. Human Blood and Tissues Repository for Neuroscience Research

   Jacksonville, Fla.

   The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).

9. 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.

10. Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment

    Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of phase 1 of this trial is to determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities [DLTs] and the total toxicity profile.

    The purpose of phase 2 of this trial is to evaluate the effectiveness of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival [PFS].