ClinicalTrials.gov record NCT04715399
UPenn Observational Research Repository on Neurodegenerative Disease
University of Pennsylvania Centralized Observational Research Repository on Neurodegenerative Disease (UNICORN)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study is building a shared repository of clinical, cognitive, speech, imaging and biospecimen data from people with neurodegenerative diseases, people at higher genetic risk, and healthy controls. Some participants provide a single (cross‑sectional) set of data; others are followed over time (longitudinal) with repeated testing and samples. There is no experimental treatment — the study collects information and samples for research use.
What it is studying. To create a multimodal collection of clinical assessments, cognitive and language testing, neuroimaging, biofluid biomarkers, and genetic data so researchers can study how neurodegenerative diseases start and change over time and how measurements relate to each other.
What the researchers hope to learn. To build a shared repository of clinical, cognitive, imaging, biomarker and genetic data; to characterize progression in cognition, language, behavior, biofluids, and neuroimaging across multiple neurodegenerative conditions; and to make data and samples available to qualified researchers to support future studies and collaborations.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The aim of this study is to create a repository of both cross-sectional and longitudinal data, including cognitive, linguistic, imaging and biofluid biological specimens, for neurodegenerative disease research and treatment.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- No intervention
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- This protocol will include 3 groups of people:
- 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)
- 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,
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
The Principal Investigator (PI) at the University of Pennsylvania seeks to better understand neurodegenerative diseases and is continually expanding research efforts and collaborations regarding the factors which may contribute to these illnesses. Investigators seek to better understand the basis of neurodegenerative conditions by creating a multimodal repository, including: clinical data such as demographic characteristics, vital signs and motor scales; cognitive and speech data; neuroimaging data; and biological specimens with associated biofluid biomarkers and genetic data. Investigators pursue acquiring these data from neurodegenerative disease patients, people at risk for neurodegenerative disease due to a family history, and unaffected adults. Targeted conditions include frontotemporal degeneration (FTD), primary progressive aphasia PPA), amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy (PSP), corticobasal syndrome (CBS), familial frontotemporal lobar degeneration (fFTLD), non-amnestic variants of Alzheimer's disease including logopenic progressive aphasia and posterior cortical atrophy, and Lewy body disease. This study aims to collect clinical and cognitive data, imaging data, and biospecimen samples from people whose background can inform research and treatment for neurodegenerative diseases, and make these samples and data available to qualified researchers at the University of Pennsylvania and collaborating academic centers and industry partners.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants provide clinical information and undergo cognitive and speech testing, give blood and other biofluid samples (for biomarker and genetic studies), and may have brain imaging. Some people will have a spinal tap (lumbar puncture) if eligible; others may be excluded from specific tests for safety reasons. Some participants join a single (cross‑sectional) visit while others are followed over time with repeat visits and tests.
How the study is structured. Observational registry with two participant paths: cross‑sectional (one set of data) and longitudinal (repeat visits over time). No interventions are given. Participants may have clinical assessments, cognitive and speech testing, imaging studies, and provide blood and other biospecimens; data and samples are stored and shared with qualified researchers. Outcome follow‑up is natural history (participants followed until withdrawal, death, end of funding, or long-term timeframes described in the record).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
Important dates
- Study start
- May 29, 2020
- Primary completion
- May 30, 2070 (estimated)
- Study completion
- May 30, 2070 (estimated)
- Target enrollment
- 1000 participants (estimated)
- Last updated on registry
- Jan 22, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Pennsylvania
- Collaborators
- National Institutes of Health (NIH)
- United States Department of Defense
- National Institute on Aging (NIA)
- Alzheimer's Association
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Emily Xie 📞 215-746-2781 ✉ emily.xie@pennmedicine.upenn.edu
- Dahlia Kamel ✉ kamel.dahlia@pennmedicine.upenn.edu
Participating sites (1)
- University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, 19104 · United States
- Gillian Bradley · 215-349-5725 · gillian.bradley@pennmedicine.upenn.edu
- Dahlia Kamel · kamel.dahlia@pennmedicine.upenn.edu
Terms used on this page · explanations by MedicalUpdates.ai
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- lumbar puncture
- A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Principal Investigator
- The doctor or scientist responsible for running the study at a site or overall.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- biospecimen
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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