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: Catherine Martinez, 617-726-4923 or cmartinez26@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: Vanessa Ibrahim, 617-643-2400 or vibrahim@mgh.harvard.edu

A Phase 2b/3 Study of Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)

Study Population: Adult participants with a clinical diagnostic of possible or probable Progressive Supranuclear Palsy or with Parkinson’s disease, experiencing symptoms for less than 5 years and able to walk independently (at least 5 steps) with minimal assistance

Description: PSP is a nervous system disease that worsens over time, causing loss of muscle control and neurological issues. To date, there are no approved treatments for PSP specifically, but some people in the early stage of the disease may benefit from taking medications used to treat Parkinson’s disease. The goal of this study is to assess the safety and efficacy of investigational drug AMX0035 compared to placebo on disease progression rate as measured by the Progressive Supranuclear Palsy (PSP) Rating Scale (PSPRS).

Principal Investigator: Anne-Marie Wills, MD, MPH

Sponsor: Amylyx Pharmaceuticals Inc

Contact: Jesse Wang, 617-643-2400 or jewang@mgh.harvard.edu

Learn more about this study 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

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: Vikram Khurana, MD, PhD

Contact: For Parkinson's Disease, contact Diego Rodriguez at drodriguez29@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:
Amy Wang, 617-724-7273 or jwang133@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: Contact: Amy Wang, 617-724-7273 or jwang133@mgh.harvard.edu

Retinal Determinants of Circadian Function and Sleep-Wake Cycles in Parkinson’s Disease

Study population: Adults with and without Parkinson’s Disease or REM sleep behavior disorder (RBD)

Description: Normal eye function and pupillary response of light are important for proper function of our internal circadian clock located in the brain to help regulate our sleep-wake cycles. If this "clock" is impaired, the regulation of our sleep and wake is impaired, and other functions such as memory and mood may be affected as well. Sleep disturbances are common non-motor symptoms of Parkinson's disease and are often resistant to dopamine treatments. We are enrolling adults diagnosed with Parkinson’s Disease or REM Sleep Behavior Disorder to understand how the relationship between the body's "clock" and the pupillary response to light is affected in Parkinson's Disease and REM sleep behavior disorder. The study procedures include an overnight sleep study, wearing an activity monitor on the wrist, physical and neurological examinations, cognitive assessments, testing of pupil response, and blood draws.

Principal Investigator: Aleksandar Videnovic, MD

Sponsor: National Institutes of Health (NIH)

Contact: Abigail Otterbein, 617-724-2644 or aotterbein@mgh.harvard.edu

A Pre-Gene Therapy Study of Early Parkinson’s or Multiple System Atrophy Progression by Longitudinal Clinical and Biomarker Assessments

Study Population: Patients with Parkinson’s disease or multiple system atrophy

Description: The goal of this trial is to assess the longitudinal progression of PD and MSA over an 18-month period using clinical assessments combined with blood and spinal fluid biomarkers. This study is being conducted to help plan future studies evaluating the efficacy of a gene therapy for PD and MSA.

Principal Investigator:Todd Herrington, MD, PhD

Sponsor: AskBio, Brain Neurotherapy Bio

Contact: Chinemeihe Alaku (calaku@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: Erin Peterec epeterec@mgh.harvard.edu

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: Jesse Wang, 617-643-2400 or jewang@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: Vanessa Ibrahim, 617-643-2400 or vibrahim@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: 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