Frontotemporal Degeneration(FTD)UNICORNNCT04715399
UPenn Observational Research Repository on Neurodegenerative Disease
An observational study of Frontotemporal Degeneration(FTD) and Primary Progressive Aphasia(PPA), run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Degeneration(FTD), Primary Progressive Aphasia(PPA), Familial Frontotemporal Lobar Degeneration (fFTLD)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2020to 30 May 2070
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: To better understand neurodegenerative diseases, the investigators will include people living with these illnesses, people at risk of developing these illnesses, and people without neurodegenerative disease who wish to contribute to science as controls.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dahlia Kamel contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Gillian Bradley, 215-349-5725, gillian.bradley@pennmedicine.upenn.edu
Dahlia Kamel, kamel.dahlia@pennmedicine.upenn.edu
About this study
Official title: University of Pennsylvania Centralized Observational Research Repository on Neurodegenerative Disease (UNICORN)
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.
Read the detailed description
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.
- Conditions
- Frontotemporal Degeneration(FTD), Primary Progressive Aphasia(PPA), Familial Frontotemporal Lobar Degeneration (fFTLD), Amyotrophic Lateral Sclerosis(ALS), Lewy Body Disease(LBD), Progressive Supranuclear Palsy(PSP)
- Being tested
- No intervention
- Medical subject headings
- Aphasia, Primary Progressive, Amyotrophic Lateral Sclerosis, Lewy Body Disease, Supranuclear Palsy, Progressive, Corticobasal Degeneration, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional | Not described Receives: Other: No intervention | |
| Longitudinal | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of progression - changes in neuropsychological tests.
The changes of neuropsychological tests (well known cognitive measures such as: Naming test, CVLT, MoCA, Oral Trails, etc.) in neurodegenerative diseases over time.
Measured: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Secondary outcomes (4)
Status of progression - changes in language processing.
The effect of changes in language processing (e.g. effortful speech, lexical-semantic representations) as categorized by impaired speech fluency, motor speech deficits and semantic memory deficits in neurodegenerative diseases over time.
Measured: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Status of progression - changes in social disinhibition.
The effect of changes in social behavioral testing, which categorized by rule violation (social disinhibition) progression in neurodegenerative diseases over time.
Measured: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Status of progression - changes in biofluids.
The change of disease status as categorized by biomarkers in biofluids in neurodegenerative diseases over time.
Measured: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Status of progression -changes in Neuroimaging
The progressive changes of images in multimodal neuroimaging techniques in neurodegenerative diseases over time.
Measured: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start29 May 2020
- Primary completion30 May 2070 (estimated)
- Study completion30 May 2070 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal Degeneration(FTD)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), United States Department of Defense, National Institute on Aging (NIA), Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- David Irwin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715399
- Sponsor's protocol ID
- 842873
- Other IDs
- R01AG054519, P01AG066597
- Acronym
- UNICORN
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information about study participants will be kept confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Only deidentified data will be shared. We will not share individual participant identifiable data with other researchers outside of the institution, unless the participant allows us to by signing a separate data release form.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Pennsylvania Centralized Observational Research Repository on Neurodegenerative Disease (UNICORN)
- ClinicalTrials.gov ID
- NCT04715399
- Acronym / sponsor ID
- UNICORN / 842873
- Conditions
- Frontotemporal Degeneration(FTD), Primary Progressive Aphasia(PPA), Familial Frontotemporal Lobar Degeneration (fFTLD), Amyotrophic Lateral Sclerosis(ALS), Lewy Body Disease(LBD), Progressive Supranuclear Palsy(PSP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), United States Department of Defense, National Institute on Aging (NIA), Alzheimer's Association
- Study start
- 29 May 2020 (actual)
- Primary completion
- 30 May 2070 (estimated)
- Study completion
- 30 May 2070 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional | – | Other: No intervention |
| Longitudinal | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To better understand neurodegenerative diseases, the investigators will include people living with these illnesses, people at risk of developing these illnesses, and people without neurodegenerative disease who wish to contribute to science as controls.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Cross-sectional, Longitudinal |
Primary outcome
Status of progression - changes in neuropsychological tests.
Time frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
The changes of neuropsychological tests (well known cognitive measures such as: Naming test, CVLT, MoCA, Oral Trails, etc.) in neurodegenerative diseases over time.
4 secondary outcomes
Status of progression - changes in language processing.
Time frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Status of progression - changes in social disinhibition.
Time frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Status of progression - changes in biofluids.
Time frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Status of progression -changes in Neuroimaging
Time frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. Information about study participants will be kept confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Only deidentified data will be shared. We will not share individual participant identifiable data with other researchers outside of the institution, unless the participant allows us to by signing a separate data release form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dahlia Kamel contact
David Irwin, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frontotemporal Degeneration(FTD) and Primary Progressive Aphasia(PPA), run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Xie (215-746-2781, emily.xie@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of progression - changes in neuropsychological tests. (time frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.