Frontotemporal DegenerationNCT03452956
Cognitive Impairement In Frontotemporal Dementia
An observational study of Frontotemporal Degeneration and Progressive Supranuclear Palsy, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontotemporal Degeneration, Progressive Supranuclear Palsy, Multiple System Atrophy
- What is being tested?
- None-Observation Only
- How many people
- 997 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2003to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All individuals with a diagnosis of FTD, PSP, or MSA, previously identified by the PI and sub-investigators through other FTD studies (protocol number 702681) and through the PI's extensive FTD clinical practice at the University of Pennsylvania and at Pennsylvania Hospital's Department of Neurology, will be recruited through letters, brochures, and study flyers.
Who may be able to join
- Individuals who have been diagnosed with FTD, PSP, and MSA
Who cannot join
- Individuals under 18 years of age
- People with pacemakers or certain metallic implants
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments.
Read the detailed description
Comparative and longitudinal studies reveal clinical differences between subgroups of patients with frontotemporal dementia (FTD), including Progressive Non-fluent Aphasia (PNFA), Semantic Dementia (SD), patients with a disorder of social comportment and personality (SOC), and non-aphasic patients with executive dysfunction (EXEC). MRI studies of cortical atrophy and fMRI studies show correlated neural defects in FTD subgroups. The investigators will obtain converging evidence from multiple sources to test hypotheses about the neural basis for cognitive functions such as semantic memory, grammatical processing, and social functioning in these FTD subgroups, while improving clinical care for these patients. Recent studies have linked progressive supra nuclear palsy (PSP) and multiple systems atrophy (MSA) to FTD. The investigators will obtain comparable neuropsychological and biomarker data in order to compare these patient groups.
- Being tested
- None-Observation Only
- Medical subject headings
- Supranuclear Palsy, Progressive, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-Observation OnlyOther
No intervention-this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| FTD Cohort | No intervention-observation only Receives: Other: None-Observation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression
Changes over time in MRI and cognitive testing data.
Measured: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
Secondary outcomes (1)
Impaired semantic memory in Semantic Dementia (SD).
The impact of cortical atrophy on language processing.
Measured: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 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 posted2 Mar 2018
- Study start1 Jul 2003
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DegenerationStudies 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
- Retrospective
- Enrolment
- 997 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452956
- Sponsor's protocol ID
- 298201
- Status last verified
- Nov 2020
- First submitted
- 26 Feb 2018
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The University of Pennsylvania is a participant in the National Alzheimer's Coordinating Center 's FTLD-NACC initiative to create a national database of data specific to FTD spectrum diseases.The FTLD NACC initiative will enable research centers focusing on FTD spectrum diseases to gather standardized data on their FTLD patients, all of which will be combined into a single database and made freely available to researchers around the world. The FTLD-NACC collects data standardly obtained in this study, including neurocognitive assessments, MRI imaging data, and biomarkers collected through lumbar puncture and blood draw.The FTLD-NACC is designed to facilitate collaborative research and will allow researchers to maximize the use of clinical information and biological material available on frontotemporal degenerative spectrum diseases. Subjects will be able to choose whether or not their research data is shared with the FTD-NACC.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairement In Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT03452956
- Acronym / sponsor ID
- 298201
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 997 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2003 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 2 Mar 2018 (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.
This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments.
Detailed description
Comparative and longitudinal studies reveal clinical differences between subgroups of patients with frontotemporal dementia (FTD), including Progressive Non-fluent Aphasia (PNFA), Semantic Dementia (SD), patients with a disorder of social comportment and personality (SOC), and non-aphasic patients with executive dysfunction (EXEC). MRI studies of cortical atrophy and fMRI studies show correlated neural defects in FTD subgroups. The investigators will obtain converging evidence from multiple sources to test hypotheses about the neural basis for cognitive functions such as semantic memory, grammatical processing, and social functioning in these FTD subgroups, while improving clinical care for these patients. Recent studies have linked progressive supra nuclear palsy (PSP) and multiple systems atrophy (MSA) to FTD. The investigators will obtain comparable neuropsychological and biomarker data in order to compare these patient groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FTD Cohort | – | Other: None-Observation OnlyNo intervention-observation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All individuals with a diagnosis of FTD, PSP, or MSA, previously identified by the PI and sub-investigators through other FTD studies (protocol number 702681) and through the PI's extensive FTD clinical practice at the University of Pennsylvania and at Pennsylvania Hospital's Department of Neurology, will be recruited through letters, brochures, and study flyers.
Key inclusion criteria (1 listed)
- Individuals who have been diagnosed with FTD, PSP, and MSA
Key exclusion criteria (3 listed)
- Individuals under 18 years of age
- People with pacemakers or certain metallic implants
- pregnant women
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 |
|---|---|---|
| None-Observation OnlyNo intervention-this is an observational study | Other | FTD Cohort |
Primary outcome
Progression
Time frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
Changes over time in MRI and cognitive testing data.
1 secondary outcome
Impaired semantic memory in Semantic Dementia (SD).
Time frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: Yes. The University of Pennsylvania is a participant in the National Alzheimer's Coordinating Center 's FTLD-NACC initiative to create a national database of data specific to FTD spectrum diseases.The FTLD NACC initiative will enable research centers focusing on FTD spectrum diseases to gather standardized data on their FTLD patients, all of which will be combined into a single database and made freely available to researchers around the world. The FTLD-NACC collects data standardly obtained in this study, including neurocognitive assessments, MRI imaging data, and biomarkers collected through lumbar puncture and blood draw.The FTLD-NACC is designed to facilitate collaborative research and will allow researchers to maximize the use of clinical information and biological material available on frontotemporal degenerative spectrum diseases. Subjects will be able to choose whether or not their research data is shared with the FTD-NACC.
Related trials for Frontotemporal Degeneration
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Enrolling by invitationPhase 2
Alzheimer's Tau Platform: Regimen A - AADvac1
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Progressive Supranuclear Palsy, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 12 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression (time frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 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 12 Nov 2020.