Clinical research has many public benefits, from increasing our understanding of health and disease to discovering new treatments. If you take part in a research study, you can help researchers learn more about health and illness. This helps us improve the way we take care of patients. You can learn more about clinical research at rally.massgeneralbrigham.org.

Interventional Trials

Interventional trials test a new treatment for a condition. Participants may be given the experimental treatment or be part of a control group which gets a placebo (inactive) treatment.

Trial of Intravenous Prasinezumab in Participants with Early Parkinson’s disease (PADOVA)

Study Population: Adults with a diagnosis of Parkinson’s disease for at least 6 months to a maximum 3 years

Description: This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with early Parkinson’s Disease (PD) who are on stable symptomatic PD medication.

Principal Investigator: Anne-Marie Wills, MD, MPH

Sponsor: Hoffman-La Roche

Contact: Arjun Laud, 617-726-4923 or alaud@mgh.harvard.edu

Trial of Parkinson’s and Zoledronic Acid (TOPAZ)

Study Population: Adults with Parkinson’s disease or neurodegenerative Parkinsonism, age 60 years or older, without history of prior hip fracture

Description: The TOPAZ trial will test if a medicine called zoledronic acid can prevent fractures in people with Parkinson’s Disease and parkinsonism. Zoledronic acid is approved for use in osteoporosis. However, the use of zoledronic acid in this study is investigational. You will receive a one-time dose of the study treatment (either zoledronic acid or a placebo). During the study, you will be contacted every four months to check if you have had any new fractures.

Principal Investigator: Anne-Marie Wills, MD, MPH

Sponsor: National Institute on Aging (NIA), Parkinson’s Foundation

Contact: To sign up for the study, please go to topaz.eurekaplatform.org or call the Parkinson’s Foundation helpline (800-4PD-INFO; 473-4636). MGH Contact: Mansi Sharma, 617-643-2400 or msharma13@mgh.harvard.edu

Pilot Trial of Targeted Vibration Therapy for Tremor Relief

Study Population: People with Parkinson’s disease

Description: The purpose of this study is to explore the use of a prototype wrist-worn device that has shown promise in addressing upper-extremity tremors, like those experienced by patients with Parkinson’s disease.

Principal Investigator: Paolo Bonato, PhD (co-investigator Christopher Stephen, MBChB)

Sponsor: Encora Therapeutics

Contact: Dr. Eric Fabara, 617-952-6336 or efabara@partners.org

A Phase IIa Study of TPN-101 in Patients with Progressive Supranuclear Palsy (Transposon)

Study Population: People diagnosed with Progressive Supranuclear Palsy

Description: The main purpose of this study is to investigate the safety and tolerability (whether side effects can be handled by a patient) of TPN-101 compared to a placebo for the treatment of PSP.

Principal Investigator: Anne-Marie Wills, MD, MPH

Sponsor: Worldwide Clinical Trials, Inc.

Contact: Mansi Sharma, 617-643-2400 or msharma13@mgh.harvard.edu

Learn more about this trial at rally.massgeneralbrigham.org.

Biomarker Studies

Biomarker studies look at specific measures of health such as the presence of certain molecules in your blood. Participants may have physical and neurological examinations, cognitive assessments, blood tests, brain scans, skin biopsies, and lumbar punctures. Researchers may perform these tests once, or repeat them over a period of time to see how the biomarkers change.

Parkinson’s Progression Markers Initiative

Study population: Adults with or without Parkinson’s disease

Description: We are enrolling adults with and without Parkinson’s Disease (PD) to investigate the way the disease develops and changes over time. We are asking volunteers to join for at least five years so that the study team can gather information on PD development and progression, as well as natural aging. Adults with Parkinson’s who have been diagnosed within the last two years and are not currently taking standard PD medications are eligible for this research study. People who have risk factors for the development of PD (known genetic mutation, loss of smell, history of physically acting out dreams during sleep, and others) may also be eligible. The study procedures include physical and neurological examinations, cognitive assessments, blood tests, brain scans, skin biopsies, and lumbar punctures.

Principal Investigator: Aleksandar Videnovic, MD

Sponsor: Michael J. Fox Foundation

Contact: Wesley Schlett, WSCHLETT@mgh.harvard.edu

Gut-Immune-Brain Axis in Parkinson’s Disease (GIB-PD)

Study population: Adults between the ages of 18 and 80 years old with a diagnosis of Parkinson’s disease in the last 3 years

Description: This study aims to increase the understanding of the role of the microbiome-gut biome axis in the progression of Parkinson’s disease (PD). By taking advantage of technology to analyze samples from people with PD, we hope to gain new information about the relationship between autoimmunity and the origins of the neurodegenerative process. It involves a one-time blood and stool collection (at home or in the office) and completion of a few questionnaires.

Principal Investigator: Ramnik Xavier, MD, PhD (co-investigator Albert Hung, MD, PhD)

Sponsor: Aligning Science Across Parkinson’s (ASAP) Initiative

Contact: Marco Kaper, 617-724-5955 or mekaper@mgh.harvard.edu

Biomarkers in Neurodegenerative Disease (Harvard Biomarkers Study)

Study Population: People with Parkinson’s Disease, Multiple System Atrophy or Cerebellar ataxia

Description: This study will collect, process, and store samples such as blood, cerebrospinal fluid, or other bodily materials to conduct research. Without collecting such samples from our patient, we will not be able to make early diagnosis of patients or track disease progression for clinical trials.

Principal Investigator: Clemens Scherzer, MD; Vikram Khurana, MD, PhD

Contact: For Parkinson's Disease, contact Yuliya Kuras at 857-307-5424 or ykuras@bwh.harvard.edu. For MS or ataxia, contact
Ariana Pitaro at atpitaro@bwh.harvard.edu.

Learn more about the Harvard Biomarkers Study.

Neuroprotective Treatment Trial Planning in REM Sleep Behavior Disorder

Study population: Adults with REM sleep behavior disorder (RBD)

Description: Rapid Eye Movement (REM) sleep behavior disorder (RBD) is a rare sleep disorder in which people move and talk during their dreaming sleep. We will be enrolling adults diagnosed with REM Sleep Behavior Disorder (RBD) into a registry to help plan for future clinical trials. The study procedures include an overnight sleep study, physical and neurological examinations, cognitive assessments, blood tests, and lumbar punctures.

Principal Investigator: Aleksandar Videnovic, MD

Sponsor: National Institutes of Health (NIH)

Contact:
Loren Lavadia, 617-724-7273 or mlavadia@mgh.harvard.edu

Study of Pupil Responses of Adults with and without Parkinson’s Disease

Study population: Adults with and without Parkinson’s Disease

Description: In this research study we want to learn more about how the eye responds to different light cues. The light that is processed by the eye is important for many processes. The sleep/wake cycle, sleep, and some hormones are affected by light processed by the eye. In some disorders and diseases, the light processing mechanisms of the eye may be affected. We want to use this information to better understand some disorders and diseases.

Principal Investigator: Elizabeth Klerman, MD, PhD (co-investigator Aleksandar Videnovic, MD)

Contact: Loren Lavadia, 617-724-7273 mlavadia@mgh.harvard.edu

Study of Nerves in the Gut of Patients with Parkinson’s Disease

Study population: Adults with Parkinson’s Disease

Description: Parkinson’s disease is traditionally considered to be a disease limited to the central nervous system; however, this view has changed in the recent years. Recent studies have demonstrated that the pathology in Parkinson’s disease also affects the peripheral nervous system including the gastrointestinal nervous system. We are enrolling adults with Parkinson’s Disease to conduct non-invasive imaging of the gastrointestinal nervous system. This imaging will be performed with technology called optical coherence tomography which offers a non-invasive alternative for full thickness imaging of the gastrointestinal nervous system at a microscopic level.

Principal Investigator: Guillermo Tearney, MD, PhD (co-investigator Aleksandar Videnovic, MD)

Contact: Loren Lavadia, 617-724-7273 or mlavadia@mgh.harvard.edu

Imaging and Diagnostic Studies

These studies help develop and improve ways to detect, diagnose and monitor disease.

Web-based Automated Imaging Differentiation of Parkinsonism (w-AIDP)

Study Population: Adults with Parkinson’s disease, Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy - Parkinsonian Type (MSA-P)

Description: The purpose of this study is to evaluate the capacity of an automated algorithm to better differentiate different parkinsonian diseases from one another using MRI. It involves 2 testing sessions at Massachusetts General Hospital: baseline and one year later (12-18 months). Visit 1 includes questionnaires, a videotaped physical exam, brief cognitive testing, and a ~30 minute MRI. Visit 2 is analogous to visit one, without the MRI.

Principal Investigator: Stephen Gomperts, MD, PhD (co-investigator Anna Goodheart, MD)

Sponsor: National Institutes of Health (NIH) and the University of Florida

Contact: Anna Goodheart agoodheart@partners.org

PET Imaging of Epigenetic Mechanisms in PD or Dementia with Lewy Bodies

Study Population: Patients with Parkinson disease (with or without thinking changes) or dementia with Lewy bodies (DLB)

Description: Martinostat PET imaging is a recently developed tool that labels brain histone deacetylase (HDAC), a master regulator of gene expression. We are using Martinostat PET imaging to evaluate HDAC expression in PD, PD dementia, and DLB. This work will help use determine how HDAC changes contribute to these illnesses and will guide future therapies including clinical trials targeting HDACs. It involves one visit to Massachusetts General which includes questionaries, a physical exam, brief cognitive testing, and a ~60 minute combined MRI-PET scan.

Principal Investigator: Stephen Gomperts, MD, PhD (co-investigator Anna Goodheart, MD)

Sponsor: National Institutes of Health (NIH) and the American Academy of Neurology (AAN)

Contact: Anna Goodheart, agoodheart@partners.org

Remote and clinical assessment of motor symptoms using wearable sensors in Progressive Supranuclear Palsy (PSP Wearables)

Study Population: Adult participants with a clinical diagnostic of possible or probable Progressive Supranuclear Palsy or with Parkinson’s disease

Description: The purpose of this study is to assess the feasibility of using wearable sensors and digital health technology to remotely monitor progression of motor, speech, and cognitive function in Progressive Supranuclear Palsy (PSP).

Principal Investigator: Anne-Marie Wills, MD, MPH

Contact: Mansi Sharma, 617-643-2400 or msharma13@mgh.harvard.edu

Learn more about this study at rally.massgeneralbrigham.org.

Genetic Studies

Genetic studies use individual or family testing to look for ways that genetics impact disease risk or progression and identify targets for new treatments.

PDGENEration Registry

Study Population: People with Parkinson’s disease, people who have a family member that has been diagnosed with Parkinson’s disease and a confirmed genetic mutation

Description: The purpose of this study is to provide clinical genetic testing for people with Parkinson’s disease and eligible family members. Learn more about PDGENEration at parkinson.org.

Principal Investigator: Anne-Marie Wills, MD, MPH

Sponsor: Parkinson’s Foundation

Contact: Arjan Laud, 617-726-4923 or alaud@mgh.harvard.edu

Deep Brain Stimulation Trials

These studies follow people using specific types of Deep Brain Stimulation (DBS) treatments to gain additional insight into how well they work and how they can be improved.

Adaptive DBS Algorithm for Personalized Therapy – Parkinson’s Disease (ADAPT-PD) Trial

Study population: Patients with Parkinson’s disease treated with Medtronic Percept deep brain stimulation devices.

Description: The purpose of this trial is to study the efficacy of adaptive closed-loop deep brain stimulation programming.

Principal Investigator: Todd Herrington, MD, PhD

Sponsor: Medtronic

Contact: Ailsa Bentley, abentley2@mgh.harvard.edu

Registry of Deep Brain Stimulation with the VERCISE™ System: Vercise™ DBS Registry

Study population: Patients with Parkinson’s disease undergoing treating with Boston Scientific deep brain stimulation (DBS) devices

Description: The purpose of this trial is to study the clinical response to DBS in routine practice.

Principal Investigator: Todd Herrington, MD, PhD

Sponsor: Boston Scientific

Contact: Ailsa Bentley, abentley2@mgh.harvard.edu

Adaptive DBS Algorithm for Personalized Therapy – Parkinson’s Disease (ADAPT-PD) Trial
Study population: Patient’s with Parkinson’s disease treated with Medtronic Percept deep brain stimulation devices
Description: The goal of this trial is to test the efficacy of adaptive or closed-loop deep brain stimulation programming for Parkinson’s disease.
Principal Investigator: Todd Herrington, MD, PhD
Sponsor: Medtronic, Inc.
Contact: Ailsa Bentley, abentley2@mgh.harvard.edu, and Todd Herrington, therrington@mgh.harvard.edu