What is UNICORN?

The Penn FTD center is a specialized group of clinicians, neuropsychologists, and scientists researching frontotemporal dementia (FTD) and related disorders. FTD and related disorders can be difficult to diagnosis since the symptoms experienced often show doctors where in the brain something is wrong but not why. Doctors cannot easily see and distinguish disease causing proteins within the brain during life, often leaving neurodegenerative diagnoses unconfirmed until autopsy. To better diagnose, understand, and treat FTD and related disorders during a patient’s life, a better understanding of the causes and natural course of FTD must be developed. Researching the biology of FTD and related disorders over time helps to contribute to improved diagnostics and development of new measures of disease progression.  

The University of Pennsylvania Centralized Observational Research Repository on Neurodegenerative disease (UNICORN) study is a study which collects a large collection of different types of data on FTD and related disorders.  The data and biological samples collected on the UNICORN study allow Penn FTD Center staff to study the biology of FTD and related disorders over time, which contributes to improving diagnosis, developing new markers of prognosis, and discovering therapeutic targets that can enhance and further the development of treatment trials aimed at treating the underlying biology of FTD and related disorders.

The UNICORN study is an observational, longitudinal research study; this means data points are collected over a long period of time without any interventions or treatment. Data is collected on an annual basis to examine potential changes in patients. The knowledge gained from this observational research study helps collaborators worldwide move the scientific understanding of disease forward to improve diagnosis and treatment for all impacted by FTD and related disorders.

The UNICORN study includes a lumbar puncture, MRI, blood draw, neurological examination, cognitive testing, family and medical history collection, and questionnaires. Individuals with a clinical diagnosis of a neurodegenerative disease, those with a family history who may or may not be symptomatic, or people with no known neurological disease who will provide control subject data are invited to participate. There are other activities individuals may be eligible for depending on diagnosis and ability to participate, such as conversation and digital speech tasks, computerized tasks, wearable technologies to measure physiologic outcomes, and 7T MRI. A research visit may be scheduled on one day or take part over several days, scheduled at participants convenience. Individuals are then asked to return annually (every nine to eighteen months) if they are willing and able to do so. As with all research, this study is entirely voluntary, which means individuals can participate for any amount of time. 

The below outlines general information on the UNICORN research study experience:

• Prior to your visit, you and your loved one will have several discussions via phone/email with one of our research coordinators to review the research program and set a schedule that works best for you. 

• Within two weeks prior to your scheduled research visit, your assigned research coordinator will meet with you via zoom to review our informed consent form, answer any questions you may have, and prepare you for the day of activities. 

• Whenever possible, research visits are aligned with existing clinical visits to Penn Medicine to minimize patient burden and travel to the site. 

• Our research coordinators stay with our participants when you are on site, and otherwise ensure that during your breaks you are with your study partner. Our priority is always patient safety and want to ensure patients are not alone during a research visit. 

Typical UNICORN Research Day activities include:

• At your baseline visit, you will likely complete a lumbar puncture, which may be accompanied with a neurological examination with one of our clinical staff. After the lumbar puncture procedure, patients lie flat on their back for one hour to rest under observation. During this time the research coordinator may collect blood samples and/or questionnaires.  

• Your annual visits (including baseline) will include cognitive testing, which is up to two hours of memory or thinking tasks, reading tasks, or writing activities. Your study partner will also complete some questionnaires and surveys during this time.  

• Your annual visits (including baseline) will also include a 3T MRI. One of our research coordinators will stay with the MRI technicians to monitor the patient during the research scan, while an additional research coordinator completes a study partner interview to collect information which helps us understand patient’s daily functioning, the caregiving relationship, and other social behavioral factors. 

• After the research day is over, patients and study partners will receive an email which includes copies of all signed consent forms, an update on your stipend reimbursement, and any additional information about further activities which may be completed over zoom in the coming weeks.

The Penn FTD Center thanks all our participants, study partners, and families for the time and effort they commit to our research program. 

~ Ashlyn O’Halloran, Clinical Research Coordinator