Frontotemporal DementiaNCT04060082
Voices Of Individuals: Challenges and Experiences Of bvFTD
An observational study of Frontotemporal Dementia and Frontotemporal Degeneration, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The VOICE Of bvFTD study is a telephone interview research study about life with or at risk for behavioral variant frontotemporal dementia (bvFTD). The study aims to understand how bvFTD impacts individuals' day to day lives, how people think about themselves, and what challenges they face. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontotemporal Dementia, Frontotemporal Degeneration, Frontotemporal Dementia, Behavioral Variant
- What is being tested?
- Telephone Interview
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jun 2019to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants for the study will be recruited through the University of Pennsylvania and ClinicalTrials.gov. Previously, participants were also recruited through Johns Hopkins University, through a dementia research study at the National Institutes of Health, through the Penn FTD Center Caregiver Conference, and through through a private Facebook group for individuals with C9orf72 mutations.
Who may be able to join
- 18 years of age or older
- Speak fluent English
- People with bvFTD must have been diagnosed with behavioral variant frontotemporal degeneration (bvFTD)
- People with a known genetic risk factor for bvFTD must have an identified disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family
- The diagnosis or genetic testing results must have been disclosed to the participant at least two months prior to study enrollment
Who cannot join
- Inability to complete the informed consent comprehension process
- Under 18 years of age
- Does not speak English
- Received diagnosis or testing result less than two months prior to study enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Medical Institution
Baltimore, Maryland, 21287
National Institutes of Health (NIH)
Bethesda, Maryland, 20892
University of Pennsylvania (Penn Frontotemporal Degeneration Center)
Philadelphia, Pennsylvania, 19104
About this study
Official title: VOICE Of bvFTD [Voices Of Individuals: Challenges and Experiences Of bvFTD]
The VOICE Of bvFTD study is a telephone interview research study about life with or at risk for behavioral variant frontotemporal dementia (bvFTD). The study aims to understand how bvFTD impacts individuals' day to day lives, how people think about themselves, and what challenges they face.
Read the detailed description
The VOICE Of bvFTD study is a study being conducted at the University of Pennsylvania. The study was developed and initiated in collaboration with the Johns Hopkins Bloomberg School of Public Health and the National Human Genome Research Institute. The goal of this study is to learn more about what it is like to live with or at high risk of developing behavioral variant frontotemporal dementia (bvFTD). The study will involve telephone interviews to help learn as much as possible about living with bvFTD. The hope is that this will guide future research, resource development, and clinical practice.
Participants will have at least two phone calls from the study team. During the initial phone call, which will take about 15 to 20 minutes, the participant will be asked some basic questions about demographics and the study details will be reviewed as part of the consent process. During another call the participant will be asked some questions to assess his or her thinking, and will complete the interview which will last about 30 to 60 minutes. There are no physical or medical procedures included in this study. The consent process, screening, interview scheduling, and the interview itself will take place over two or three phone calls, which may occur over several weeks.
A person may be able to take part in this study if they are a person with bvFTD, or if they have been found to have a genetic change that causes bvFTD.
- Conditions
- Frontotemporal Dementia, Frontotemporal Degeneration, Frontotemporal Dementia, Behavioral Variant, FTD
- Being tested
- Telephone Interview
- Keywords
- FTD, Interview, Genetics, Persons diagnosed, Frontotemporal degeneration, bvFTD, Chromosome 9 open reading frame 72 (C9ORF72), Microtubule-associated protein tau (MAPT), Progranulin (GRN), TAR DNA-binding protein (TARDBP), Valosin-Containing Protein (VCP), Charged multivesicular body protein 2B (CHMP2B)
- Medical subject headings
- Frontotemporal Dementia, Pick Disease of the Brain, Frontotemporal Dementia With Motor Neuron Disease, Inclusion Body Myopathy With Early-Onset Paget Disease And Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone InterviewOther
Participants will be asked to answer questions about their experiences with FTD.
| Study group | Role | What they receive |
|---|---|---|
| Persons Diagnosed | Individuals with a diagnosis of bvFTD. Receives: Other: Telephone Interview | |
| Persons At Risk | Individuals with a known genetic risk factor for bvFTD: people with genetic testing that identified a disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family Receives: Other: Telephone Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective and Behavioral Responses
How participants describe and categorize their emotional reactions to receiving a diagnosis of bvFTD or positive genetic testing result, and their experiences living with that knowledge. It will also explore how patients describe their behavior in response to the testing or diagnosis, such as use of coping strategies, challenges faced, and decisions to disclose their status to family and friends.
Measured: Through study completion: about 1.5-2 hours total over several weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start26 Jun 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies 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
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Owczarzak, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthLori Erby, PhD, ScM, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060082
- Sponsor's protocol ID
- 833507
- Status last verified
- Jan 2026
- First submitted
- 14 Aug 2019
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOICE Of bvFTD [Voices Of Individuals: Challenges and Experiences Of bvFTD]
- ClinicalTrials.gov ID
- NCT04060082
- Acronym / sponsor ID
- 833507
- Conditions
- Frontotemporal Dementia, Frontotemporal Degeneration, Frontotemporal Dementia, Behavioral Variant, FTD
- Keywords
- FTD, Interview, Genetics, Persons diagnosed, Frontotemporal degeneration, bvFTD, Chromosome 9 open reading frame 72 (C9ORF72), Microtubule-associated protein tau (MAPT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Aug 2019 (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 VOICE Of bvFTD study is a telephone interview research study about life with or at risk for behavioral variant frontotemporal dementia (bvFTD). The study aims to understand how bvFTD impacts individuals' day to day lives, how people think about themselves, and what challenges they face.
Detailed description
The VOICE Of bvFTD study is a study being conducted at the University of Pennsylvania. The study was developed and initiated in collaboration with the Johns Hopkins Bloomberg School of Public Health and the National Human Genome Research Institute. The goal of this study is to learn more about what it is like to live with or at high risk of developing behavioral variant frontotemporal dementia (bvFTD). The study will involve telephone interviews to help learn as much as possible about living with bvFTD. The hope is that this will guide future research, resource development, and clinical practice.
Participants will have at least two phone calls from the study team. During the initial phone call, which will take about 15 to 20 minutes, the participant will be asked some basic questions about demographics and the study details will be reviewed as part of the consent process. During another call the participant will be asked some questions to assess his or her thinking, and will complete the interview which will last about 30 to 60 minutes. There are no physical or medical procedures included in this study. The consent process, screening, interview scheduling, and the interview itself will take place over two or three phone calls, which may occur over several weeks.
A person may be able to take part in this study if they are a person with bvFTD, or if they have been found to have a genetic change that causes bvFTD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons Diagnosed | – | Other: Telephone InterviewIndividuals with a diagnosis of bvFTD. |
| Persons At Risk | – | Other: Telephone InterviewIndividuals with a known genetic risk factor for bvFTD: people with genetic testing that identified a disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for the study will be recruited through the University of Pennsylvania and ClinicalTrials.gov. Previously, participants were also recruited through Johns Hopkins University, through a dementia research study at the National Institutes of Health, through the Penn FTD Center Caregiver Conference, and through through a private Facebook group for individuals with C9orf72 mutations.
Key inclusion criteria (5 listed)
- 18 years of age or older
- Speak fluent English
- People with bvFTD must have been diagnosed with behavioral variant frontotemporal degeneration (bvFTD)
- People with a known genetic risk factor for bvFTD must have an identified disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family
- The diagnosis or genetic testing results must have been disclosed to the participant at least two months prior to study enrollment
Key exclusion criteria (4 listed)
- Inability to complete the informed consent comprehension process
- Under 18 years of age
- Does not speak English
- Received diagnosis or testing result less than two months prior to study enrollment
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 |
|---|---|---|
| Telephone InterviewParticipants will be asked to answer questions about their experiences with FTD. | Other | Persons At Risk, Persons Diagnosed |
Primary outcome
Affective and Behavioral Responses
Time frame: Through study completion: about 1.5-2 hours total over several weeks
How participants describe and categorize their emotional reactions to receiving a diagnosis of bvFTD or positive genetic testing result, and their experiences living with that knowledge. It will also explore how patients describe their behavior in response to the testing or diagnosis, such as use of coping strategies, challenges faced, and decisions to disclose their status to family and friends.
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 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Frontotemporal Dementia
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
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.
Jill Owczarzak, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Lori Erby, PhD, ScM principal investigator
National Institutes of Health (NIH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frontotemporal Dementia and Frontotemporal Degeneration, run by University of Pennsylvania at 3 sites 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 5 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: finished, as of the sponsor's last update on 12 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 3 sites 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?
Affective and Behavioral Responses (time frame: Through study completion: about 1.5-2 hours total over several weeks). 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 Jan 2026.