About the PASSPORT clinical trial

RESEARCHING A NEW INVESTIGATIONAL STUDY DRUG FOR PSP

PARTICIPANT BROCHURE (PDF)

The PASSPORT clinical trial is researching whether a new investigational study drug can slow disease progression in study participants with PSP. We’re looking to recruit approximately 396 adults from various countries to participate.

Recruitment to join the clinical trial is now underway.

This Progressive Supranuclear Palsy clinical trial lasts for at least a year

The main clinical trial lasts just over a year. It is divided into a 6-week screening period and a 52-week double-blind dosing period. Once this portion of the clinical trial concludes, there will also be an opportunity to participate in an open-label dosing period.

Study participants will be divided into two groups to investigate the investigational study drug

  • Study participants’ groups will be assigned by chance and study participants will have a two in three chance of receiving the investigational study drug

  • Both the investigational study drug and the inactive substance (placebo) will be administered via an intravenous (into the vein) infusion (also known as a drip)

  • This infusion will take place approximately every 4 weeks at the trial clinic. Each time it will take about an hour to administer. You will then need to stay at the trial clinic a further 2 hours for monitoring

  • During both dosing periods, some visits can be performed at home as long as appropriate services are available to carry out the necessary procedures and monitoring. Your clinical trial investigator will give you more information about this

Trial clinic visits are every 4 weeks

Taking part in this PSP clinical trial means visiting a trial clinic approximately every 4 weeks during the first year. This is when study participants can receive their dose of the investigational study drug. During visits, the clinical trial team will also carry out various tests to monitor how study participants are progressing.

Typical tests include:

Physical examinations

(e.g., height and weight)

Vital signs checks

(e.g., temperature, breathing rate and pulse)

Neurological examinations

(to assess the status of PSP)

Blood tests

Assessment of any side effects you may experience

Scans

(to assess any changes in the brain)

Electrocardiograms

(a painless way to look at the heart's electrical activity)

Questionnaires for you and your caregiver

(to assess general well-being)

Other optional procedures

  • There will also be an optional sub-study (a ‘study’ within a clinical trial) to determine how and where the investigational study drug is distributed throughout your body. Only selected trial clinics will take part in the sub-study

  • This sub-study will involve three lumbar punctures (also known as a ‘spinal tap’) which will be carried out only at selected trial clinics

  • Even if a trial clinic is selected to give trial lumbar punctures, study participants are not required to have the procedure if they do not want to – participation in the main clinical trial will not be affected by your decision to undergo lumbar punctures

  • If you do choose to take part, more information will be given to you by your clinical trial team

Please see the FAQ section to read about lumbar punctures.

We are collaborating with a number of reputable clinics that are involved in the PASSPORT clinical trial. Please see a list of participating clinics below:

  • Erica Boyd, Mayo Clinic Hospital, Phoenix, Arizona, boyd.erica@mayo.edu, 480-342-1316
  • Molly Goddard, Banner Sun Health Research Institute, Sun City, Arizona, molly.goddard@bannerhealth.com, 623-832-5726
  • Mary Harrigan, St. Joseph’s Hospital and Medical Centre, Dignity Health, BNI Neurology Clinics, Phoenix, Arizona, mary.harrigan@dignityhealth.org, 602-406-9593
  • Evan Moreno-Davis, The Parkinson's and Movement Disorder Institute, Fountain Valley, California, evan@pmdi.org, 714-378-5021
  • Mary Freeman, USF Morsani Center, Tampa, Florida, mfreema4@health.usf.edu, 813-974-4685
  • Jocelyne Fimiano, Parkinson's Disease and Movement Disorder Center, Boca Raton, Florida, jfimiano@parkinsonscenter.org, 561-392-1818 xt6
  • ZsaZsa R Brown, Northwestern University, Chicago, Illinois, zsazsa.brown@northwestern.edu, 312-503-4121
  • Alexandra Fowler, The University of Kansas Medical Center, Kansas City, Kansas, afowler3@kumc.edu, 913-588-6924
  • Ashley LaRoche, Ochsner Medical Center (OMC), New Orleans, Louisiana, ashley.laroche@ochsner.org, 504-703-0755
  • Jordan Jara, Neurology Department, Lahey Hospital & Medical Center, Burlington, Massachusetts, jordan.jara@lahey.org, 781-744-2958
  • Renee Najor, Quest Research Institute, Farmington Hills, Michigan, renee@questri.com, 248-957-8940
  • Sharon Evans, Parkinson's Disease and Movement Disorder Center, Albany, New York, evanss@amc.edu, 518-262-6682
  • Mindy Lopez, Icahn School of Medicine at Mount Sinai Parkinson's and Movement Disorders Center, New York City, New York, mindy.lopez1@mssm.edu, 212-241-2199
  • Shonna Jenkins, Medical University of South Carolina, Charleston, South Carolina, jenkisho@musc.edu
  • Katie L. Sullivan, University of Virginia Health System, Charlottesville, Virginia, kls8d@virginia.edu, 434-982-6599

To find out if you are eligible for this clinical trial, please take a few minutes to complete a short pre-screening questionnaire

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