Brief Title
UPenn Observational Research Repository on Neurodegenerative Disease
Official Title
University of Pennsylvania Centralized Observational Research Repository on Neurodegenerative Disease (UNICORN)
Brief 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.
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 Type
Observational
Primary Outcome
Status of progression - changes in neuropsychological tests.
Secondary Outcome
Status of progression - changes in language processing.
Condition
Frontotemporal Degeneration(FTD)
Intervention
No intervention
Study Arms / Comparison Groups
Cross-sectional
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1000
Start Date
May 29, 2020
Completion Date
May 30, 2070
Primary Completion Date
May 30, 2070
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
David Irwin, MD, 215 349-5725, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04715399
Organization ID
842873
Secondary IDs
R01AG054519
Responsible Party
Principal Investigator
Study Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)
Study Sponsor
David Irwin, MD, Principal Investigator, University of Pennsylvania
Verification Date
January 2023