Creating a repository for neurodegenerative disease data
University of Pennsylvania Centralized Observational Research Repository on Neurodegenerative Disease (UNICORN)
University of Pennsylvania · NCT04715399
This study is creating a large collection of information about neurodegenerative diseases to help researchers learn more and develop better treatments for people affected by these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04715399 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a comprehensive repository of data related to neurodegenerative diseases, including cognitive, linguistic, imaging, and biological specimens. The University of Pennsylvania is leading this observational research to gather both cross-sectional and longitudinal data from individuals diagnosed with various neurodegenerative conditions, those at risk due to family history, and healthy controls. The collected data will include clinical characteristics, cognitive assessments, neuroimaging results, and biological samples, which will be made available for further research and treatment development. The goal is to enhance understanding of these diseases and support future studies.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with neurodegenerative diseases, those with a family history of such conditions, and healthy adults for control data.
Not a fit: Patients under 18 or those with confounding conditions that may interfere with study findings will not benefit from this study.
Why it matters
Potential benefit: If successful, this repository could significantly advance research and treatment options for patients with neurodegenerative diseases.
How similar studies have performed: Other studies have successfully utilized similar multimodal approaches to gather data on neurodegenerative diseases, indicating a promising avenue for research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: This protocol will include 3 groups of people: 1. People with a clinical diagnosis of a neurodegenerative disease. such as frontotemporal degeneration(FTD), primary progressive aphasia(PPA), Lewy body disease(LBD), amyotrophic lateral sclerosis(ALS), progressive supranuclear palsy(PSP), corticobasal syndrome(CBS), posterior cortical atrophy(PCA), Alzheimer's disease(AD), Parkinson's disease(PD) 2. People with a family history of neurodegenerative disease who may or may not be symptomatic, and may or may not be mutation carriers such as familial frontotemporal lobar degeneration (fFTLD) or familial ALS, 3. People with no known neurological disease who will provide control data. Exclusion Criteria: * Anyone who is under the age of 18. * Anyone with a condition or in a situation which, in the Investigator's opinion, could confound the study findings or may interfere significantly with a person's participation, including but not limited to neurological, psychological and other medical conditions (such as cardiac, neurosurgical, infectious conditions). * Individual participants may be excluded from some, but not all, study procedures for safety reasons when they have a contraindication or at the discretion of the Investigator. For example, persons with metal implants which are not MRI-safe will not be able to take part in imaging, and those on blood thinning medications may not be able to take part in lumbar puncture. * Pregnant women; if a woman becomes pregnant during the study, research activities that may increase risk to the patient and the unborn fetus will be stopped until the end of pregnancy, at which point participation can be resumed.
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: David Irwin, MD — University of Pennsylvania
- Study coordinator: Emily Xie
- Email: emily.xie@pennmedicine.upenn.edu
- Phone: 215-746-2781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Frontotemporal Degeneration, Primary Progressive Aphasia, Familial Frontotemporal Lobar Degeneration, Amyotrophic Lateral Sclerosis, Lewy Body Disease, Progressive Supranuclear Palsy, Corticobasal Syndrome, Posterior Cortical Atrophy