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Study of new investigative drug for individuals with Progressive Supranuclear Palsy
This project is not recruiting.
Overview
What we are studying
This is a Phase II trial that investigates whether an investigational drug called BMS-986168 can safely treat patients with Progressive Supranuclear Palsy (PSP) and slow disease progression. BMS-986168 is an antibody that attaches to a protein (tau) thought to contribute to neurodegeneration in individuals with PSP. It is hoped that by binding to and reducing tau proteins, BMS-986168 can slow or stop further neurodegeneration.
Why it is important
PSP is a slowly progressive degenerative disease characterized by frequent falls, Parkinsonism, difficulty swallowing and cognitive changes. Currently, no drugs are approved by the Food and Drug Administration for the treatment of PSP. Thus there is an urgent need for new treatments for this illness.
What we hope to accomplish
We hope to demonstrate that BMS-986168 can safely and effectively improve or slow the progression of symptoms in individuals with PSP. To date, BMS-986168 has been studied in 49 healthy adults and 72 patients with PSP in Phase I trials. It has been safe and well-tolerated by study participants. Although Phase I trials have shown that BMS-986168 is safe and well-tolerated, the effectiveness of the drug has yet to be investigated. This Phase II study will compare the rate of change in PSP symptoms in individuals who are administered BMS-986168 versus individuals who are given a placebo.
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Principal Investigator
Who can participate
MGH is seeking individuals with probable Progressive Supranuclear Palsy (PSP) between the ages of 41 and 86. Study subjects must have noticed the start of their symptoms within the past 5 years and must be able to walk 10 steps with the assistance of a walker. To participate in this study, study subjects also must have a reliable caregiver who can accompany them to each study visit. A caregiver can be anyone who assists the study subject for at least 3 hours each week.
Who cannot participate
Indivduals with other significant psychiatric or neurological disorders besides Progressive Supranuclear Palsy cannot participate in this study. Individuals must not have a history of alcohol or drug abuse, and can't smoke more than 10 cigarettes each day. History of other major diseases could also prevent you from participating in this study. Please contact study stuff if you have questions about your ability to participate in the study.
What you may be asked to do
Study participants will first be asked to attend a screening visit at which the study doctor will ensure that they qualify for the study. As part of the screening process, participants will be asked to have their brain imaged using MRI. In this study, about 396 patients worldwide (about 5-10 at Mass General Hospital) will be enrolled and will be followed for at least 1 year. Patients will be randomly assigned in a 2:1 ratio (66% active drug, 33% placebo) to 2000 mg of BMS-986168 by IV infusion about once a month. Participants will undergo several tests and procedures as part of the study. If a participant qualifies to participate in the study, they will return to MGH every 4 weeks to receive an IV-infusion of either 2000mg of BMS-986168 or placebo. At each visit, the study doctor will perform neurological and safety assessments. Over the course of the study, participants will be asked to receive 2 lumbar punctures (spinal taps) and 2 additional MRIs. There will also be a series of cognitive tests adminstered during study visits. Caregivers will be asked to give reports about the study participant at each study visit.
Project activities may include:
- Blood draw
- Injection or IV
- Office visit
- MRI scan
- Medication
Estimated Time Commitment
15 visits over 14 months
What You May Get
Local participants will receive $50 in compensation for travel and meal expenses for each study visit. Participants who must travel over 150 miles for a study visit are eligible for travel expense reimbursement. Travel-related expenses include, but are not limited to, air travel, hotel lodging, gas mileage, and meals. All participants will receive $100 in compensation for each study visit that requires a lumbar puncture. Ask study staff for more information.
Location
Translational and Clinical Research Center
55 Fruit Street, White Building Floor 12, Boston, MA 02114
Travel
- Out of state travel possibly reimbursed
Additional Information
Study Phase
Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.
Funding Source
- Industry