Frontotemporal Lobar Degeneration (FTLD)NCT07333898
Digital Measurements of Motor and Voice Functions in FTD
An observational study of Frontotemporal Lobar Degeneration (FTLD) and Frontotemporal Dementia (FTD), run by BioSensics.
Trial summary
The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with FTLD syndromes. Researchers at BioSensics and Johns Hopkins School of Medicine will use wearable sensors, computerized speech, psychomotor, and cognitive… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD), Corticobasal Syndrome
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2028
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study intends to enroll a diverse population of individuals representative of the general FTLD syndrome population. There are no restrictions based on race or ethnic origin. This study will enroll both male and female participants aged 40 years or older with a clinical diagnosis of possible or probable FTLD syndrome phenotype.
Who may be able to join
- Male and female participants aged 40 years or older with a clinical diagnosis of possible or probable FTLD syndrome phenotype.
- Participants must be fluent in reading and speaking English and must be capable of providing informed consent based on the principal investigator's judgment.
- Individuals eligible for inclusion must be able to comply with the protocol per the investigator's judgment and must have a caregiver or study partner who is willing and able to assist with all study-related procedures.
Who cannot join
- Any neurological, medical, or psychiatric condition that would preclude or confound participation in study activities based on the investigator's judgment.
- Individuals who have a history of frequent falls defined as more than 5 falls per month.
About this study
The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with FTLD syndromes.
Researchers at BioSensics and Johns Hopkins School of Medicine will use wearable sensors, computerized speech, psychomotor, and cognitive assessments to create outcome measures and digital biomarkers for FTLD syndromes. Researchers will deploy this digital health solution to monitor 20 patients with FTLD syndromes for 12 months with study visits every 3 months.
Read the detailed description
Frontotemporal degeneration (FTD) spans the spectrum of rare neurodegenerative disorders affecting movement, behavior, and cognitive function. FTD represents a group of disorders including progressive supranuclear palsy (PSP - a severe and rapidly progressive FTD disorder estimated to affect at least 20,000 Americans), frontotemporal dementia (FTD, the second most common cause of early-onset (<65) dementia), primary progressive aphasia, semantic dementia, and corticobasal syndrome.
The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with FTLD syndromes.
Twenty patients with FTLD syndromes will be recruited from Johns Hopkins University School of medicine to participate in this 12-month study with visits every 3 months. The investigators aim to assess the correlation between outcomes as measured by the PAMSys pendant and PAMSys ULM wrist monitoring sensors, and clinical/functional assessments used for FTLD syndromes (bvFTD, nfPPA, SD, and CBS), including the FTD Rating Scale (FTDRS), Cortical Basal ganglia Functional Scale (CBFS), PSP Rating Scale (PSPRS), Frontal Assessment Battery (FAB) (lexical fluency and Go-No-Go tasks), FTLD-CDR, modified Interpersonal Reactivity Index (mIRI Perspective Taking and Empathic Concern subscales summed to obtain a total Empathy score), the Pyramids and Palm Trees test (PPT), the Bedside Western Aphasia Battery-Revised (BWAB-R), digit span, phonemic fluency, category fluency, color trails, and trails A and B in individuals with different stages of FTLD disease severity. The results will be used to develop and validate monitoring symptoms and function in FTLD syndromes. In an exploratory aim, the caregiver burden (Zarit Burden Inventory) and its relationship to patients' empathy levels (mIRI) will be assessed.
The secondary objective of this study is to conduct free-flowing interviews with participants and clinical experts using the Technology Acceptance Model (TAM). This approach will help us examine perceptions of benefit, technology acceptance, technological anxiety, trust, facilitating conditions, perceived risk, and attitudes towards use from the perspectives of both patients and clinicians.
- Conditions
- Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD), Corticobasal Syndrome, Corticobasal Syndrome(CBS), Corticobasal Degeneration
- Keywords
- digital health, wearable sensors, frontotemporal lobar degeneration
- Medical subject headings
- Frontotemporal Lobar Degeneration, Frontotemporal Dementia, Corticobasal Degeneration
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 |
|---|---|---|
| Frontotemporal Lobar Degeneration (FTLD) | 20 patients who have a clinical diagnosis of possible or probable FTLD syndrome phenotype. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Monitoring
Following each clinical visit, participants will be asked to wear a PAMSys pendant sensor and two PAMSys ULM wrist sensors for 14 days at home. The average daily number of steps will be measured using the PAMSys pendant.
Measured: 12 months
Hand Function Monitoring
Following each clinical visit, participants will be asked to wear two PAMSys ULM wrist sensors for 14 days at home. Average daily number of hand goal-directed movements will be measured using the PAMSys ULM wrist sensors.
Measured: 12 months
Secondary outcomes (4)
Zarit Burden Interview (ZBI)
The ZBI is completed by a reliable caregiver. The ZBI scores range from 0-88, where 88 represents a worse outcome.
Measured: 12 months
Montreal Cognitive Assessment (MoCA)
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
Measured: 12 months
Cortical Basal Ganglia Functional Scale (CBFS)
The CBFS is a rating scale that evaluates experiences in daily living (EDL's) and consists of 14 questions on Motor EDL's and 17 questions on Non-Motor EDL's, each of which are rated on a Likert 5 point scale rating function from 0 to 4, where 0 = Normal or No problems and 4 = Severe problems. The questions are for the patient, but should be answered by both the patient and their caregiver together.
Measured: 12 months
Progressive Supranuclear Palsy Rating Scale (PSPRS)
The PSP Rating Scale (PSPRS) is a 28-item clinical assessment used to measure the severity and progression of Progressive Supranuclear Palsy (PSP). Out of the 28-items, 6 are scored on a 3 point scale (0-3) and 22 are scored on a 4 point scale (0-4). The PSPRS ranges from a score of 0-100 with a higher number representing a greater impairment from the disease.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal Lobar Degeneration (FTLD)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333898
- Sponsor's protocol ID
- BioDigit FTLD-03
- Other IDs
- Digital Assessment Tools Award
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No