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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