Clinical Trials Corner

Twitchy Woman Jen Heath will keep you up-to-date on the latest clinical trials for People with Parkinson’s.

If you are unfamiliar with Clinical Trials, this video explains the process:
What is a Clinical Research Study? The Michael J. Fox Foundation for Parkinson’s Research website guides you through the process of signing up for a clinical trial. Use the link provided below.

You are given many options in determining if a clinical trial is the right fit for you, including distance you are willing to travel and number of in-person visits required throughout the study. Be sure to read the inclusion and exclusion criteria! Fox Trial Finder | Parkinson’s Diseas

PD Trials of Interest:

April 2024

LIGHT–PD

The University of Rochester and Dr. Ray Dorsey have an interesting new clinical trial in which you participate from the comfort of your own home, doesn’t involve changes to your current meds, and you can earn $500.00! All interactions with the medical team will be via Zoom and phone.

This is a 7 month trial that involves the use of a device that emits a specialized light therapy to determine whether or not it provides a positive impact on both motor and non- motor symptoms.

Requirements:

*45 years or older

*Have been taking Parkinson’s medicine for at least 1 year

*Dosage must be stable the month before starting the study

*No changes to medication throughout the study *Your doctor may deny your eligibility if it is determined that severe dyskinesia or off time problems may interfere with results.

Click on the link below

https://celestepd.squarespace.com/ apply

The University of Rochester is building a computer system that allows anyone from anywhere in the world to perform standard Parkinson’s tests by modulating facial expressions, speech, or gestures, using a computer browser and receiving an automated assessment on Parkinson’s symptoms. They are seeking individuals with and without Parkinson’s Disease to take part in a research study to determine the best possible way of sharing both the screening and symptoms progression information with individuals after conducting a set of tasks.

If you participate, you will be asked to go through a website where you perform speech and motor tasks in front of a webcam, and then provide your feedback on the website. Study participation takes about 30 minutes.

Study participation is limited to individuals who speak English and reside outside of the European Union. You will receive an Amazon gift card ($15) after you complete the program if you choose to accept it.

If you are interested and have not completed the study before, please complete this form and a study team member will contact you: https://redcap.link/PDfeedbac

LUMA 201

This is an investigational, double-blind study evaluating the safety and efficacy of a drug to determine if it can delay the progression of Parkinson’s Disease in individuals who have not yet started taking medication. This drug in this study is an LRRK2 inhibitor. It works slowing down or inhibiting the production and build-up of a protein that is believed to cause damage to cells that results in the development of symptoms associated with PD.

Participation Criteria:

*received a Parkinson’s diagnosis within the last 2 years

*have never been treated with Parkinson’s medication

*between 30 and 80 years old

Click here for more information

March 2024

SPARX3

The SPARX3 clinical trial is a great one if you have been diagnosed with PD, have not yet started on medicine, and love to exercise! There are 24 sites throughout the US that have opportunities for participants.

https://www.sparx3pd.com
Volunteers must be:

40-80 years old
Diagnosed with PD within the last 3 years
Not yet taking medications for PD symptoms
Not planning to start medications for PD symptoms in the next 6 months
Not currently participating in a structured exercise program
Available to take part in a regular treadmill exercise program 4x/week for 18 months in study visits periodically for 24 months
Comfortable with physical and cognitive assessments, blood draws, and Imaging scans (DaTscan) at the start and end of the study

Lenrispodun

Lenrispodun is an adjunctive therapy for patients experiencing motor fluctuations.

This is a Phase 2 double-blind, placebo, fixed dose trial that will last approximately 9 weeks,

which includes a 4 week window in which participants will take either Lenrispodun or a placebo.

This trial is designed for Parkinson’s patients who initially had positive results while taking levodopa, but are now experiencing dyskinesia and/or off times. This trial is ongoing at 28 locations throughout the USA.

Link:ITCIClinicalTrials@itci-inc.com

Phone Number: 646-440-9333

TOPAZ Trial

You are invited to participate in a research study for the Prevention of Fractures in Patients with Parkinson’s Disease and Parkinsonism.

Join the Study

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Online Studies

My MovesMatter.

This study is based on an app developed by one of our Twitchy Women, Richelle Flanagan from Ireland. Richelle is collaborating with the Department of Anatomy and Neuroscience, School of Medicine at University College Cork on this.trial, “Tracking Parkinson’s Disease Symptoms, Medications, and Menstruation”. It is currently only available for women living in Europe, however, anyone can download the app. The app is user friendly, and helps you track PD symptoms, medicine, exercise, and your menstrual cycle. This is an excellent way to keep track of the information you need for appointments with your neurologist, as well as Primary Care doctor and OBGYN. Click on the link below for more information about this study and instructions for downloading the app.

https://www.mymovesmatter.com/uccpilotstudy?utm_campaign=5d93f716-7784-4fe2-b484-7f6c4a59cf9d&utm_source=so&utm_medium=mail&cid=90b0b584-b9d1-4cc3-be10-9fddddac9aa1

On-line for the NIH National Institute of Neurological Disorders and Stroke

This is not a trial, but a survey for the NIH, in collaboration with Mass General Brigham, which consists of 3 short answer questions seeking the perspectives of PWP, caregivers, and family/friends to identify experiences with pre clinical trial challenges. The purpose is to obtain information to assist in eliminating some of the things that impede the length of time it takes in all phases of clinical trials. The opinions we provide will be added to information collected from academic researchers and funders of trials and research. The questions require some time and thought, but this is a great way to assist in making the clinical trial process more efficient.

https://forms.office.com/pages/responsepage.aspx?id=eHW3FHOX1UKFByUcotwrBuHRqTTAmcBPttlkHQm0jXRUNjVMVTBNTDEzUjFKNU1UV0pFRk9WMjg5Ry4u

Fox Foundation Trials Seeking Participants

Oral Medication to Stop Parkinson’s Disease Progression: Researchers at Inhibikase Therapeutics are testing whether a new oral drug, Risvodetinib (IkT-148009), can slow or stop the progression of Parkinson’s disease, by partially or completely restoring lost functions. The study is seeking volunteers between 30 to 80 years of age who have not received treatment related to PD in the past. Learn more about eligibility and join the study.  

Understanding the Effects of a Treatment for Early Parkinson’s Disease: Roche is evaluating a novel drug, RO7486967, to see if it’s safe and well tolerated for users. The primary goal of the new drug is to treat people in the early stages of Parkinson’s disease. Researchers of this study will be looking at the potential side effects and participants’ self-reported experience with the drug. With 15 study centers available in the United States, the study is recruiting volunteers diagnosed with the disease within the last three to five years. Learn more about eligibility

Online
This is one you can do from home using your computer or smartphone every 3 months.
https://www.michaeljfox.org/ppmi

In-person at 18 locations in the USA
STEM-Parkinson’s Disease
This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson’s disease.