Frontotemporal Degeneration (FTD)BRAINNCT07798700
Biofluid Research on Age-Related or Inherited Neurodegeneration
An observational study of Frontotemporal Degeneration (FTD) and ALS (Amyotrophic Lateral Sclerosis), run by University of Pennsylvania at 1 site in United States.
Trial summary
The aim of this study is to contribute to and continue to sustain a repository of blood samples, nucleic acid (DNA and/or RNA) samples, family history information, and other demographic information from individuals with age-related neurodegenerative conditions, or their family members who may or may not be at risk for… 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), ALS (Amyotrophic Lateral Sclerosis), Primary Progressive Aphasia (PPA)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 1 Jan 2070
- Phase
- Observational
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: This study will recruit adults over the age of 18 who fit into one of the three study groups defined in the eligibility criteria above.
Who may be able to join
- People with a clinical diagnosis of a neurodegenerative disease including, but not limited to Alzheimer's disease (AD), Parkinson's disease (PD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy (PSP), primary progressive aphasia (PPA), limbic-predominant age-related TDP-43 encephalopathy (LATE), corticobasal syndrome (CBS), posterior cortical atrophy (PCA), primary lateral sclerosis (PLS), primary muscular atrophy (PMA), or individuals with a suspected neurodegenerative dementia and/or movement disorder of unknown etiology will be considered for enrollment
- Family Members of individuals who meet the criteria of group 1, who are people who may or may not be at risk for a similar neurodegenerative disease, who may or may not be symptomatic, and who may or may not have known or unknown genetic risk.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Cara Joyce, MPH, 267-271-0740, cara.joyce@pennmedicine.upenn.edu
Emily Xie, emily.xie@pennmedicine.upenn.edu
About this study
Official title: Biofluid Research on Age-Related or Inherited Neurodegeneration (BRAIN)
The aim of this study is to contribute to and continue to sustain a repository of blood samples, nucleic acid (DNA and/or RNA) samples, family history information, and other demographic information from individuals with age-related neurodegenerative conditions, or their family members who may or may not be at risk for similar conditions. This study will continue to further expand research into the molecular and genetic basis of these diseases and their risk factors.
- Conditions
- Frontotemporal Degeneration (FTD), ALS (Amyotrophic Lateral Sclerosis), Primary Progressive Aphasia (PPA), Familial Frontotemporal Lobar Degeneration (fFTLD), Fronto-temporal Lobar Dementia, Dementia With Lewy Bodies (DLB)
- Keywords
- Dementia, ALS, FTD, Familial FTD, Familial ALS, Neurodegeneration, Neuromuscular Diseases, Movement Disorder, Neurodegenerative Diseases
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Aphasia, Primary Progressive, Lewy Body Disease, Alzheimer Disease, Supranuclear Palsy, Progressive, Parkinson Disease, limbic-predominant age-related TDP-43 encephalopathy, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with a clinical diagnosis of neurodegenerative disease | People with a clinical diagnosis of a neurodegenerative disease including, but not limited to Alzheimer's disease (AD), Parkinson's disease (PD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy (PSP), primary progressive aphasia (PPA), limbic-predominant age-related TDP-43 encephalopathy (LATE), corticobasal syndrome (CBS), posterior cortical atrophy (PCA), primary lateral sclerosis (PLS), primary muscular atrophy (PMA), or individuals with a suspected neurodegenerative dementia and/or movement disorder of unknown etiology will be considered for enrollment. | |
| Family members of individuals meeting criteria for group 1 | Family Members of individuals who meet the criteria of group 1, who are people who may or may not be at risk for a similar neurodegenerative disease, who may or may not be symptomatic, and who may or may not have known or unknown genetic risk. | |
| Healthy Controls | People with no known neurological disease who will provide control data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To contribute to and continue to sustain a repository biological samples and data from individuals with age-related neurodegenerative conditions.
To contribute to and continue to sustain a repository of blood samples, nucleic acid (DNA and/or RNA) samples, family history information, and other demographic information from individuals with age-related neurodegenerative conditions.
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 (3)
To collect and bank data and biospecimen samples
To collect and bank data and biospecimen samples locally and at collaborating data and biobank repositories in support of neurodegenerative disease research. Data and biospecimen samples may be collected as part of an external protocol (e.g., a different Penn IRB-approved observational protocol, clinical trial, or consortium study) in which participants may be co-enrolled
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.
To collect data and biospecimen samples from people who wish to participate in research but are unable to participate or do not meet eligibility criteria for other research protocols at our lab.
To collect data and biospecimen samples from people who wish to participate in research but are unable to participate or do not meet eligibility criteria for other research protocols at our lab, e.g., a carrier of a rare genetic variant associated with a neurodegenerative disease.
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.
To extend analysis, maintenance, and sharing of existing data.
To extend analysis, maintenance, and sharing of existing data, imaging, and biospecimen samples collected by our lab under previous research protocols
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 posted1 Sep 2026
- Study start12 Dec 2025
- Primary completion1 Jan 2070 (estimated)
- Study completion1 Jan 2070 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- University of Pennsylvania Institute on Aging, National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Corey McMillan, PhD, University of Pennsylvania
- Investigators
- Corey McMillan, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798700
- Sponsor's protocol ID
- 858812
- Other IDs
- P01AG066597, P30AG072979, RF1NS145263
- Acronym
- BRAIN
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational trial, and there is no benefit to sharing IPD.
Publications
None to list.