New Clinical Trial
Jun 12, 2018 By Lucas Metherall
NEW CLINICAL RESEARCH TRIAL FOR PROGRESSIVE SUPRANUCLEAR PALSY (PSP) IS NOW RECRUITING
Progressive Supranuclear Palsy (PSP) is a neurodegenerative disease. In brain cells affected by PSP, there is an abnormal accumulation of a protein called tau. Tau protein forms “tangles” in the brain cells. It can spread outside the affected brain cell in the form of extracellular (eTau) or “toxic tau”. The toxic tau is taken up by nearby healthy brain cells and by this route, the disease spreads in the brain. This spreading results in the neurological symptoms of PSP.
PSP imposes a substantial physical, emotional and financial burden on both patients and their families. One of the main challenges with diagnosis is that the symptoms resemble other neurodegenerative conditions – such as Parkinson’s disease – so diagnosis of PSP is typically made only after ruling out other possible causes, resulting in substantial delay to obtain an accurate diagnosis. There are currently no approved – or effective – treatments for PSP and the average survival time from onset of symptoms is around 7.4 years. Due to the rapidly progressing nature of PSP, early diagnosis and referral, with timely intervention, offers the best hope of effective care for PSP patients.
The investigational study drug is an antibody which sticks to toxic tau and helps remove it from the space between the cells of the brain. It may prevent the spreading of toxic tau to normal cells. The effectiveness and safety of the investigational study drug is being evaluated in the PASSPORT clinical trial, a phase 2b clinical trial conducted in PSP study participants. For study participants with PSP and their caregiver, the PASSPORT clinical trial represents an opportunity to be a partner in finding a new investigational treatment for this disease.
We are helping BioGen recruit into the PASSPORT clinical trial approximately 396 adults from various countries with PSP who:
- Are between the ages of 41 and 86
- Can walk at least 10 steps either independently or with assistance
- Have a reliable caregiver who can attend all clinical trial visits
- Are not living in a nursing facility or dementia care facility
Overview of the PASSPORT clinical trial
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.
All clinical trial-related medications, tests and assessments will be given to study participants at no cost. Reimbursement for travel and other trial-related expenses may be available.
To find out more about this clinical trial, and find a recruiting site near you, please visit passportstudy.com.
