Clinical Studies for Neurology

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Title: A Phase 2, randomized, blinded, placebo-controlled study to evaluate safety, tolerability, pharmacometrics and efficacy of DNTH103 in adults with generalized Myasthenia Gravis ( MAGIC)
Brief Title: DNTH103 in adults with generalized Myasthenia Gravis ( MAGI
Brief Summary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
For info regarding 2024P000498 please contact Pushpa Narayanaswami at 617-667-8130 or pnarayan@bidmc.harvard.edu
 
Title: Therapeutic Amyloid Reduction and Cortical Excitability in Alzheimers disease
Brief Title: TRACE-AD
Brief Summary: The purpose of this study is to understand how amyloid removal is beneficial to the brain in Alzheimers Disease. We hope this will help us improve future treatment options. We will enroll 40 Alzheimers disease participants who are planning to start lecanemab (an anti-amyloid agent) through BIDMCs clinical treatment program. TMS and EEG measures of cortical excitability will be assessed at Baseline and periodically over 18 months of treatment. This study will allow us to determine the extent to which the beneficial effects of amyloid removal on cognitive decline may be mediated through improvements in cortical excitablity. If you qualify for and take part in the study, you would undergo all study related visits and testing at no charge. The study requires approximately 12 in-person visits. You will be compensated for your time and transportation will be provided for any in-person visits.
For info regarding 2024P000337 please contact Stephanie Buss at 617-975-8542 or sbuss@bidmc.harvard.edu
 
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Determine the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-LIBREXIA-STROKE (Sponsor protocol 70033093STR3001)
Brief Title: LIBREXIA Stroke
For info regarding 2024P000117 please contact Jennifer Dearborn-Tomazos at 617-667-1803 or jtomazos@bidmc.harvard.edu
 
Title: A Randomized, Double-Blind, Placebo-Controlled Trial of CVN424 in Early Parkinson’s Disease
Brief Title: Early Parkinson’s Disease Monotherapy with CVN424
Brief Summary: This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.
For info regarding 2023P001154 please contact Hannah Babcock at 617-667-9890 or hbabcock@bidmc.harvard.edu
 
Title: A Multicenter Phase 2, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Ucb0022 In Study Participants With Advanced Parkinson’S Disease
Brief Title: UCB_PD0060 Atlantis_0027/0391
Brief Summary: The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC) (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced Parkinson's Disease (PD).
For info regarding 2023P001063 please contact Clementina Ullman at 617-667-2355 or cullman@bidmc.harvard.edu
 
Title: Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH): a Prospective, Randomized Trial
Brief Title: GTX-104 (Nimodipine Injection for IV Infusion) for aSAH
Brief Summary: The purpose of this study is to deliver nimodipine via IV directly into the bloodstream and to determine if this is as safe and tolerable as oral nimodipine capsules.
For info regarding 2023P001045 please contact Corey Fehnel at 617-667-7000 or cfehnel@bidmc.harvard.edu
 
Title: Expectations and Experiences of Narcolepsy Symptoms in Pregnancy
Brief Title: Narcolepsy Symptoms in Pregnancy
Brief Summary: This study seeks to fill the critical knowledge gap on the evidence-based management of narcolepsy type 1 (narcolepsy with cataplexy) during pregnancy. By gathering data on the severity and impact of narcolepsy symptoms before, during, and after pregnancy, this mixed-methods study aims to better define symptom trajectory, treatment approaches, and current gaps in care for pregnant people with narcolepsy. This study will include an on-line questionnaire plus an optional interview.
For info regarding 2023P001041 please contact Margaret Blattner, MD PhD at 617-667-3237 or mblattne@bidmc.harvard.edu
 
Title: Parkinsons Disease Repository
Brief Title: Parkinsons Disease Repository
Brief Summary: The purpose of this protocol is to establish a repository of patients with Parkinsons disease (PD) or parkinsonism and collect a range of variables to inform future research project development, future research questions and overall program development. This repository will also aid in the facilitation and coordination of patient engagement in research protocols, collect screening information, and track patients through ongoing and completed studies and study-related procedures.
For info regarding 2023P000893 please contact Aine Russell at 617-667-2351 or arussel2@bidmc.harvard.edu
 
Title: Identifying dynamic biomarkers associated with rTMS response in depression: a pilot study
Brief Title: Dynamic biomarkers of rTMS response in depression
For info regarding 2023P000469 please contact Roscoe Brady Jr. MD PhD at 617-754-1261 or robrady@bidmc.harvard.edu
 
Title: Tablet application for the screening and monitoring of movement disorders
Brief Title: Drawing Analysis for Screening of Parkinsons Disease
Brief Summary: We are trying to develop a way to measure movement disorders in people (e.g. Parkinsons Disease). We are testing people on a variety of drawing tasks using an iPad and a stylus. We plan to analyze how people perform on the tasks. We will use this information to create more accurate, faster, and more convenient tasks and determine whether these drawing tasks will provide us with information that is useful in understanding which movement disorder a patient has or whether they do not have a movement disorder.
For info regarding 2023P000280 please contact Jay Iyer at jiyer@bidmc.harvard.edu
 
Title: Feasibility of the comfort measures only time out (CMOT) to reduce distress during Palliative Withdrawal of Mechanical Ventilation
Brief Title: Feasibility of comfort measures only time out (CMOT)
Brief Summary: Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are expected and involve the removal of ventilator support, or palliative withdrawal of mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that patient suffering can be common; with 30-59% of patients going through this process experiencing distress. Thus, experts and national organizations have called for evidence to inform guidelines for WMV. This research study will 1) develop and refine a Comfort Measures Only Time out (CMOT) intervention consisting of a structured time out with check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2 surgical) among 40 WMV patients.
For info regarding 2023P000160 please contact Corey Fehnel at 617-667-7000 or cfehnel@bidmc.harvard.edu
 
Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson’s Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
Brief Title: BIA 28-6156-201
Brief Summary: The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).
For info regarding 2023P000123 please contact Samuel Frank at 617-667-4889 or sfrank2@bidmc.harvard.edu
 
Title: A Phase 3, Multicenter, Open-Label Safety Study To Evaluate The Long-Term Safety And Tolerability Of Sage-718 In Participants With Huntington’s Disease
Brief Title: OPEN-LABEL SAFETY STUDY OF SAGE-718
Brief Summary: The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD)
For info regarding 2023P000122 please contact Simon Laganiere at 617-667-7000 or slaganie@bidmc.harvard.edu
 
Title: A novel protocol for diagnosing idiopathic hypersomnia
Brief Title: Home sleep testing for diagnosing Idiopathic Hypersomnia
For info regarding 2023P000058 please contact Liz Roy at 617-975-7636 or eroy2@bidmc.harvard.edu
 
Title: Characterizing non-restorative sleep in post-viral disease to advance intervention innovations
Brief Title: Nonrestorative sleep in post-viral disease
Brief Summary: This study is being done to understand why people with (ME/CFS) and Long COVID may experience nonrestorative sleep. Non-restorative sleep means that you do not feel refreshed or well rested after sleeping. We hope to learn more about things that might affect your sleep. For example, how your bodys systems, such as your immune system (the system that helps you fight infections) and hormones (chemicals that signal different functions in your body) are related to non-restorative sleep. We hope that learning more about non-restorative sleep can help with future treatment.
For info regarding 2022P001036 please contact Janet Mullington, PhD at 617-667-5243 or postviralsleep@bidmc.harvard.edu
 
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study To Evaluate The Safety, Biomarkers, And Efficacy Of Tominersen In Individuals With Prodromal And Early Manifest Huntington’s Disease
Brief Title: Tominersen (RO7234292) In Prodromal And Early Manifest Hunti
Brief Summary: This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease
For info regarding 2022P001011 please contact Samuel Frank at 617-667-4889 or sfrank2@bidmc.harvard.edu
 
Title: Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease
Brief Title: BIIB122/DHL151 in Patients with Parkinsons Diseanse
Brief Summary: In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study: - Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it. - Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. - Certain medications for PD will be allowed at enrollment for a subset of participants. - Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.
For info regarding 2022P000831 please contact Hannah Babcock at 617-667-9890 or hbabcock@bidmc.harvard.edu
 
Title: Prospective validation of electronic seizure diary forecasting
Brief Title: Prospective validation of electronic seizure diary forecasti
Brief Summary: This study hopes to be able to find a method to forecast, or predict, when seizures will happen in those with temporal lobe epilepsy. This would allow someone to take the necessary precautions in order to alleviate, or even prevent, a seizure event. This is a virtual study, and participants will be using a website and an app to track their seizures and medications. Participation is approximately 10 months.
For info regarding 2022P000548 please contact Daniel Goldenholz at 617-632-8930 or EpilepsyPlusDataScience@bidmc.harvard.edu
 
Title: Electrophysiological and ultrasound quantitative biomarkers for myofascial pain
Brief Title: Quantitative biomarkers for myofascial pain
Brief Summary: This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.
For info regarding 2022P000543 please contact Seward Rutkove at 617-667-8130 or srutkove@bidmc.harvard.edu
 
Title: Abbott DBS Post market Study of Outcomes for Indications over Time
Brief Title: ABT-CIP-10300
Brief Summary: The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.
For info regarding 2022P000324 please contact Aine Russell at 617-667-1337 or arussel@bidmc.harvard.edu
 
Title: PAIN in PASC: The Role of Sleep Disturbances
Brief Title: PAIN in PASC: The Role of Sleep Disturbances
Brief Summary: Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID.
For info regarding 2022P000257 please contact Jennifer Scott-Sutherland, MA at (617)667-5243 or COVIDSleep@bidmc.harvard.edu
 
Title: Audio Markers of Speech and Cognition in Neurodegenerative Disease (Audio-ND)
Brief Title: Audio-HD
Brief Summary: The purpose of this research is to establish biomarkers (a medical sign that can be measured reliably) for both speech and cognitive impairment in Huntingtons disease using a speech analyzing application. Participants must either have a confirmed genetic diagnosis of Huntingtons disease or be a heathy volunteer. Participants will undergo demographics and medical history review, cognitive tests, questionnaires, and a 10-minute speech assessment.
For info regarding 2022P000181 please contact Luis Sierra at 617-667-2351 or hdresearch@bidmc.harvard.edu
 
Title: 58-Week Open-Label Trial of Tavapadon in Parkinson’s Disease (Tempo-4 Trial)
Brief Title: CVL-751-PD-004
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.
For info regarding 2022P000008 please contact Aine Russell at 617-667-9885 or arussel2@bidmc.harvard.edu
 
Title: Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Brief Title: CAPTIVA
Brief Summary: The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.
For info regarding 2022C000315 please contact Sarah Marchina at smarchin@bidmc.harvard.edu
 
Title: Visual restoration of losses caused by cortical damage: a new protocol to promote fast recovery
Brief Title: Reduction of Visual Field Deficits
Brief Summary: This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of one half of the visual field. The goal of this project is to elaborate and refine a rehabilitation protocol for VFD participants. It is hypothesized that visual restoration training using moving stimuli coupled with noninvasive current stimulation on the visual cortex will promote and speed up recovery of visual abilities within the blind field in VFD participants. Moreover, it is expected that visual recovery positively correlates with reduction of the blind field, as measured with traditional visual perimetry: the Humphrey visual field test or an eye-tracker based visual perimetry implemented in a virtual reality (VR) headset. Finally, although results will vary among participants depending on the extent and severity of the cortical lesion, it is expected that a bigger increase in neural response to moving stimuli in the blind visual field in cortical motion area, for those participants who will show the largest behavioral improvement after training. The overarching goals for the study are as follows: Group 1a will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual training on a Virtual Reality (VR) device in stroke cohorts, including both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.
For info regarding 2021P000804 please contact Lorella Battelli at 617-667-0203 or lbattell@bidmc.harvard.edu
 
Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Summary: To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
For info regarding 2021P000373 please contact Aine Russell at 617-667-9885 or arussel2@bidmc.harvard.edu
 
Title: Web-based Automated Imaging Differentiation of Parkinsonism
Brief Title: wAID-P
Brief Summary: We are recruiting participants for a new study who have Parkinsons Disease (PD), Multiple System Atrophy (MSA), or Progressive Supranuclear Palsy (PSP) who are willing to undergo one MRI to test the performance of a web-based software tool.
For info regarding 2021C000078 please contact Aine Russel at 617-667-9885 or arussel2@bidmc.harvard.edu
 
Title: Brain Plasticity in Type-2 Diabetes
Brief Title: Brain Plasticity in Type-2 Diabetes
Brief Summary: The overall goal of this research is to learn more about changes in the structure and physiology (function) of the brain that occur in people with diabetes as they get older and how these changes relate to cognition (thinking) and other markers of brain health. By comparing the results from the diabetes groups with people who do not have diabetes, we hope to increase our understanding of why some people with diabetes develop problems with their cognition as they get older and have a higher risk of developing Alzheimers disease. You are invited to take part in this research study if you have type-2 diabetes or are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes about 6 in-person research visits, to be completed in about 8-10 weeks.
For info regarding 2020P001152 please contact Andrew Northrop at (617)667-0271 or anorthro@bidmc.harvard.edu
 
Title: Brain Plasticity in Cognitive Aging
Brief Title: Plasticity in cognitive aging
Brief Summary: The overall goal of this research is to learn more about changes in the structure and physiology (function) of the brain that occur as people age and how these changes relate to cognition (thinking) and other markers of brain health. You are invited to take part in this research study if you are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes 4 in-person research visits, to be completed in about 6 weeks.
For info regarding 2020P000889 please contact Christie Morse at (617)667-8412 or cmorse2@bidmc.harvard.edu
 
Title: Non-invasive Brain Stimulation for Gamma-induction and Cognitive Enhancement in FTD
Brief Title: Gamma Induction in FTD
Brief Summary: This is an interventional, sham controlled, double-blind study designed to investigate the safety, tolerability and efficacy of 40 Hz transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, delivered for 6 weeks once daily in frontotemporal dementia (FTD) patients. Cognition, gamma EEG activity and brain metabolism via FDG-PET will be measured before and after the tACS intervention.
For info regarding 2020P000457 please contact Lorella Battelli at 617-667-0326 or lbattell@bidmc.harvard.edu
 
Title: MS-LINK: The MS Leadership and Innovation Network (MS-LINK) Outcomes Study: A Comprehensive Prospective Longitudinal Assessment of Patient and Clinical Reported Outcomes in Multiple Sclerosis Patients across North America
Brief Title: MS-LINK
Brief Summary: The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes. In this study participants will be followed from the time of consent through the lifetime of the study (currently 3 years), unless the participant chooses to withdraw from the study. Collection of participant's medical history, including MS and treatment history, will be automated through extraction from the participant's electronic medical record (EMR) and other health information systems (for example, radiology). Participants will complete patient-reported outcomes (PROs) and other health-related information digitally. Participating participants will have access to their own data in an ongoing manner via a web-based Participant Portal.
For info regarding 2020C001235 please contact Emma Saart/John Dempsey at 617-667-3726 or msresearch@bidmc.harvard.edu
 
Title: A pilot study on the technical feasibility of an electrical impedance tomography device for Quantitative Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (ALS) Patients
Brief Title: EIT in ALS
Brief Summary: This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. The study will enroll patients with ALS in one cohort and healthy volunteers in a second cohort that will both undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure.
For info regarding 2020C001010 please contact Soleil Samaan at 617-667-3053 or ssamaan@bidmc.harvard.edu
 
Title: Trial of Parkinson’s and Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for Prevention of Fractures in Patients with Parkinson’s Disease
Brief Title: TOPAZ
Brief Summary: This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.
For info regarding 2020C000829 please contact Aine Russel at 617-667-9885 or arussel2@bidmc.harvard.edu
 
Title: HEALEY ALS Platform Trial
Brief Title: HEALEY ALS Platform Trial
Brief Summary: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
For info regarding 2020C000221 please contact Seward Rutkove at 617-667-8130 or srutkove@bidmc.harvard.edu
 
Title: Neural networks in presymptomatic Huntingtons Disease
Brief Title: Neural networks in presymptomatic Huntingtons Disease
Brief Summary: The primary aim of this study is to investigate the changes in the neural networks of attention in the early “presymptomatic” phase of Huntington’s disease. The second aim is to correlate these imaging changes with performance on a cognitive/attentional task.
For info regarding 2019P000943 please contact Luis Sierra at 617-667-2351 or hdresearch@bidmc.harvard.edu
 
Title: Prevalence and impact of obstructive sleep apnea in multiple sclerosis
Brief Title: Prevalence and impact of obstructive sleep apnea in multiple
Brief Summary: This study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.
For info regarding 2019P000494 please contact Emma Saart/John Dempsey at 617-667-3726 or msresearch@bidmc.harvard.edu
 
Title: Gamma Induction for Amyloid Clearance in Alzheimer’s Disease
Brief Title: Gamma Induction for Amyloid Clearance in Alzheimer’s Disease
Brief Summary: Alzheimer's Disease (AD) is characterized by amyloid-ß (Aß) plaque buildup and phosphorylated tau (p-tau) in the brain, as well as widespread neurodegeneration. Amyloid-ß and tau are proteins that build up in the brain that may contribute to memory problems. The evidence suggests that both amyloid and tau play a critical role in AD and interventions that reliably and safely decrease the intracerebral burden of amyloid or tau could potentially be of marked clinical importance. Currently, therapeutic options are very limited and while there are pharmacologic interventions that transiently improve cognitive function, there are no treatments that alter disease progression. The purpose of this study is to see if multiple daily sessions of non-invasive brain stimulation can affect brain activity to decrease the amount of amyloid and tau in people with AD as compared to Sham (placebo) stimulation. The type of brain stimulation that will be used is called transcranial alternating current stimulation (tACS). This study will investigate different doses of tACS (2-4 weeks) and assess safety. The hope is that tACS will decrease the amount of amyloid and tau and improve memory and thinking in people with AD.
For info regarding 2019P000092 please contact Lorella Battelli at 617-667-0326 or lbattell@bidmc.harvard.edu
 
Title: Treating Hyperexcitability in Alzheimers Disease with Levetiracetam to Improve Brain Function and Cognition
Brief Title: Treating Hyperexcitability in AD with LEV
Brief Summary: The aim of this study is to explore the relationship between cortical hyperexcitability, abnormalities of brain network function, and cognitive dysfunction in human patients with AD and whether administration of the antiepileptic medication levetiracetam (LEV) normalizes these measures and improves cognition.
For info regarding 2019P000091 please contact Carol Abedelnour at 617-667-0386 or cabedeln@bidmc.harvard.edu
 
Title: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Brief Title: ASPIRE
Brief Summary: Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.
For info regarding 2019C000787 please contact Magdy Selim at 617-632-8913 or mselim@bidmc.harvard.edu
 
Title: Sleep for Stroke Management And Recovery Trial
Brief Title: SleepSMART
Brief Summary: The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
For info regarding 2019C000228 please contact Sarah Marchina at smarchin@bidmc.harvard.edu
 
Title: The Functional Neuroanatomy of the Human Physiological Stress Response
Brief Title: Functional Neuroanatomy of Physiological Stress
Brief Summary: The purpose of this study is to examine the effect of a moderately low blood sugar stress on the nervous system. The investigators hope that information obtained from completing this study will help to reveal information about how a non-psychological stress impacts the parts of the brain that react to stress and the autonomic nervous system. The autonomic nervous system is the part of the nervous system that provides the body with involuntary or automatic control of heart rate, blood pressure, and breathing.
For info regarding 2019C000177 please contact Roy Freeman at 617-632-8454 or rfreeman@bidmc.harvard.edu
 
Title: A Prospective Registry Study in a Global Huntingtons Disease Cohort
Brief Title: A Prospective Registry Study in a Global Huntingtons Diseas
Brief Summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
For info regarding 2018P000332 please contact Samuel Frank at 617-667-4889 or sfrank2@bidmc.harvard.edu
 
Title: StATins Use in intRacereberal hemorrhage patieNts
Brief Title: (Statins in ICH (SATURN Trial)
Brief Summary: The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype. An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.
For info regarding 2018C000515 please contact Magdy Selim at 617-632-8913 or mselim@bidmc.harvard.edu
 
Title: Gait pattern analysis in neurological disease
Brief Title: Gait pattern analysis in neurological disease
Brief Summary: The purpose of this study is to investigate whether speed-dependent measures of gait can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders.
For info regarding 2015P000310 please contact Veronica van der Horst at 617-667-0519 or vvanderh@bidmc.harvard.edu