Progressive Supranuclear PalsyPPP-PSPNCT05501431
Personalized Parkinson Project PSP Cohort
An observational study of Progressive Supranuclear Palsy and Brain Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
There is an urgent need for the development of digital progression biomarkers, which are sensitive to detect small, but potentially clinically relevant changes in the disease course. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy, Brain Diseases, Neurodegenerative Diseases
- What is being tested?
- Verily Study Watch
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2021to 15 Sep 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: PSP-cohort: any adult with PSP who meets the inclusion criteria and does not meet the exclusion criteria. HC-cohort: any adult who meets the inclusion criteria and does not meet the exclusion criteria.
Who may be able to join
- Subject has possible or probable PSP, according to the established international criteria defined by the Movement Disorders Society (MDS-PSP criteria, Höglinger et al, 2017); diagnosis is confirmed based on by consensus review process. In addition to the diagnosis of the own treating neurologist, the diagnosis always needs to be confirmed by at least one neurologist with deep expertise in movement disorders. The videotaped neurological examination as obtained during visit 1 will be used by the expert neurologist.
- Subject is an adult, at least 50 years of age.
- Subject can read and understand Dutch.
- Subject has completed the Informed Consent, as approved by the Institutional Review Board (IRB).
- Subject is willing, competent, and able to comply with all aspects of the protocol.
- Subject is able to walk at least 5 steps with or without minimal assistance (ie, stabilization of 1 arm or use of a cane or walker).
Show all 12Show fewer
- Subject has no neurological or musculoskeletal disorder or any other condition that impairs movement, gait, or balance, in the opinion of the Investigator.
- Subject is an adult, at least 50 years of age.
- Subject can read and understand Dutch.
- Subject has completed the Informed Consent, as approved by the IRB.
- Subject is willing, competent, and able to comply with all aspects of the protocol.
- Subject is able to walk at least 5 steps with or without minimal assistance (i.e., stabilization of 1 arm or use of a cane or walker).
Who cannot join
- Subject has an additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study.
- For Study Watch: subject is allergic to nickel.
Trial locations and contacts
1 site in 1 country.
About this study
There is an urgent need for the development of digital progression biomarkers, which are sensitive to detect small, but potentially clinically relevant changes in the disease course. Digital biomarkers are based on (i) continuously collected real-time data, during the patient's day to day activities; and (ii) task-based assessment. In this study the investigators are interested in developing algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (i) sensor data obtained by means of passive monitoring during daily living; and (ii) sensor data collected during the Virtual Motor Exam.
Read the detailed description
Rationale In light of the advent of a wide range of new disease modifying treatments, and acknowledging that existing clinical outcome measures may well be insufficiently sensitive to detecting small but potentially clinically relevant changes in the disease course, there is an urgent need for development of digital progression biomarkers, not only in the field of Parkinson's disease, but also in the field of the various forms of atypical parkinsonism, including Progressive Supranuclear Palsy (PSP).
Study Design Prospective, longitudinal, single-center cohort study.
Study Objectives The primary objective is to develop algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (1) sensor data obtained by means of passive monitoring during daily living; and (2) sensor data collected during the Virtual Motor Exam.
The second objective of this study is to create a longitudinal dataset describing the clinical and functional characteristics of a representative PSP cohort to allow researchers to investigate important unanswered questions in PSP.
Study population 50 patients with possible or probable PSP, according to established international criteria (i.e., MDS-PSP criteria); diagnosis confirmed by consensus review of a videotaped neurological examination by two neurologists with deep expertise in movement disorders. In addition, we will include 50 age and gender matched healthy controls.
Main study parameters/endpoints The primary study endpoints are the annual changes in the newly developed digital measurements, extracted from the Verily Study Watch. Secondary endpoints include standardized evaluations for motor, cognition, neuropsychological, quality of life and ADL assessments. Additionally, whole blood for DNA and serum will be collected in the PSP subjects, to use for e.g. genotyping and phenotyping.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness For data collection, the study assessor will visit each participant at home twice within an interval of 1 year ± 60 days. All study assessments are routine exams done in standard clinical practice and are generally well tolerated, which takes up to 2 hours each time. PSP subjects will also be asked to consent to a blood draw once. During their 1-year participation, each participant will wear the Verily Study Watch daily for up to 23 hours. This small, unobtrusive electronic device is easily worn and poses no significant safety risk. All participants will be asked to complete a set scheduled tasks twice a day, once a week, which altogether takes 15-20 minutes of their time.
As data collection is not performed for immediate diagnostic or therapeutic purposes, there will be no direct benefits for the subjects enrolled in this study. Patients may indirectly benefit from the study, as their data contribute to providing novel etiological insights for improving the use of existing treatments, developing of new therapeutic approaches, and increasing the precision of personalized disease management.
- Conditions
- Progressive Supranuclear Palsy, Brain Diseases, Neurodegenerative Diseases, Movement Disorders
- Being tested
- Verily Study Watch
- Keywords
- Progressive Supranuclear Palsy, Biomarkers, Wearable sensors, Disease progression
- Medical subject headings
- Supranuclear Palsy, Progressive, Brain Diseases, Neurodegenerative Diseases, Movement Disorders, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verily Study WatchDevice
The Verily Study Watch is a smartwatch, collecting physiological and/or environmental information. The sensors collect data that include movement and activity, pulse rate, skin impedance, electrocardiogram (ECG), environmental temperature, and ambient light level.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Supranuclear Palsy (PSP) | Participants with possible or probable PSP, wearing the Verily Study Watch for 1 year. Receives: Device: Verily Study Watch | |
| Healthy Controls (HC) | Participants without a neurological condition, age and gender matched to the PSP cohort, , wearing the Verily Study Watch for 1 year. Receives: Device: Verily Study Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual change in digital biomarkers for gait
Identify (a combined set of) gait-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for gait will be selected cannot be defined on forehand, as this is part of the analytical approach.
Measured: From baseline till one year follow-up
Annual change in digital biomarkers for bradykinesia
Identify (a combined set of) bradykinesia-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for bradykinesia will be selected cannot be defined on forehand, as this is part of the analytical approach.
Measured: From baseline till one year follow-up
Annual change in digital biomarkers for falls
Identify (a combined set of) falls-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for falls will be selected cannot be defined on forehand, as this is part of the analytical approach.
Measured: From baseline till one year follow-up
Annual change in digital biomarkers for rising from a chair
Identify (a combined set of) features related to rising from a chair extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for rising from a chair will be selected cannot be defined on forehand, as this is part of the analytical approach.
Measured: From baseline till one year follow-up
Secondary outcomes (6)
Annual change in digital biomarker for motor performance
Standardized evaluation, by means of 8 tasks, included in the Virtual Motor Examination. Which outcome and which Unit of Measure for motor performance will be selected cannot be defined on forehand, as this is part of the analytical approach.
Measured: Baseline till one year follow-up
Annual change in cognition
Cognition will be assessed by means of the Mini-Mental State Examination version 2 (MMSE-2), on a 0-30-point scale.
Measured: Baseline till one year follow-up
Annual change in D-KEFS trail making test
D-KEFS (Delis-Kaplan Executive Function System) trail making test is a neuropsychological test for executive functioning, with scores in seconds to perform the task.
Measured: Baseline till one year follow-up
Annual change in semantic fluency
The semantic fluency test is a neuropsychological assessment, measuring executive function and semantic memory. The score entails the number of correct and unique words produced within a 60 seconds timeframe.
Measured: Baseline till one year follow-up
Annual change in quality of life
Quality of life is captured by means of a general scale, i.e., EQ-5D-5L. The EQ-5D-5L consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Baseline till one year follow-up
Annual change in Activities of Daily Living (ADL) performance
Modified Schwab \& England Activities of Daily Living is a method of assessing the capabilities of people with impaired mobility. The scale uses percentages to represent how much effort and dependence on others people need to complete daily chores.
Measured: Baseline till one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 May 2021
- Primary completion14 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma, Verily Life Sciences LLC
- Responsible party
- Sponsor
- Investigators
- Bastiaan R Bloem, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501431
- Sponsor's protocol ID
- NL75356.091.20
- Acronym
- PPP-PSP
- Status last verified
- Sep 2024
- First submitted
- 11 Aug 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset generated in this study will become available to qualified researchers worldwide, provided research questions are approved by the Research and Data Sharing Review Committee (RDSRC). The RDSRC will protect subjects' privacy by limiting the availability of the study data and controlling access to sources of information that might potentially be used to identify the individual subjects associated with the bio-specimen analysis. The RDSRC will assess the relevance and scientific quality of research proposals for which study data or material is requested. These responsibilities include the consideration of applications for: * access to the resources obtained in this study, including data or biomaterials * applications for endorsement of a scientific project using study materials; * applications for endorsement of a clinical study using study materials.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Parkinson Project PSP Cohort
- ClinicalTrials.gov ID
- NCT05501431
- Acronym / sponsor ID
- PPP-PSP / NL75356.091.20
- Conditions
- Progressive Supranuclear Palsy, Brain Diseases, Neurodegenerative Diseases, Movement Disorders
- Keywords
- Progressive Supranuclear Palsy, Biomarkers, Wearable sensors, Disease progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UCB Pharma, Verily Life Sciences LLC
- Study start
- 1 May 2021 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 15 Aug 2022 (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.
There is an urgent need for the development of digital progression biomarkers, which are sensitive to detect small, but potentially clinically relevant changes in the disease course. Digital biomarkers are based on (i) continuously collected real-time data, during the patient's day to day activities; and (ii) task-based assessment. In this study the investigators are interested in developing algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (i) sensor data obtained by means of passive monitoring during daily living; and (ii) sensor data collected during the Virtual Motor Exam.
Detailed description
Rationale In light of the advent of a wide range of new disease modifying treatments, and acknowledging that existing clinical outcome measures may well be insufficiently sensitive to detecting small but potentially clinically relevant changes in the disease course, there is an urgent need for development of digital progression biomarkers, not only in the field of Parkinson's disease, but also in the field of the various forms of atypical parkinsonism, including Progressive Supranuclear Palsy (PSP).
Study Design Prospective, longitudinal, single-center cohort study.
Study Objectives The primary objective is to develop algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (1) sensor data obtained by means of passive monitoring during daily living; and (2) sensor data collected during the Virtual Motor Exam.
The second objective of this study is to create a longitudinal dataset describing the clinical and functional characteristics of a representative PSP cohort to allow researchers to investigate important unanswered questions in PSP.
Study population 50 patients with possible or probable PSP, according to established international criteria (i.e., MDS-PSP criteria); diagnosis confirmed by consensus review of a videotaped neurological examination by two neurologists with deep expertise in movement disorders. In addition, we will include 50 age and gender matched healthy controls.
Main study parameters/endpoints The primary study endpoints are the annual changes in the newly developed digital measurements, extracted from the Verily Study Watch. Secondary endpoints include standardized evaluations for motor, cognition, neuropsychological, quality of life and ADL assessments. Additionally, whole blood for DNA and serum will be collected in the PSP subjects, to use for e.g. genotyping and phenotyping.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness For data collection, the study assessor will visit each participant at home twice within an interval of 1 year ± 60 days. All study assessments are routine exams done in standard clinical practice and are generally well tolerated, which takes up to 2 hours each time. PSP subjects will also be asked to consent to a blood draw once. During their 1-year participation, each participant will wear the Verily Study Watch daily for up to 23 hours. This small, unobtrusive electronic device is easily worn and poses no significant safety risk. All participants will be asked to complete a set scheduled tasks twice a day, once a week, which altogether takes 15-20 minutes of their time.
As data collection is not performed for immediate diagnostic or therapeutic purposes, there will be no direct benefits for the subjects enrolled in this study. Patients may indirectly benefit from the study, as their data contribute to providing novel etiological insights for improving the use of existing treatments, developing of new therapeutic approaches, and increasing the precision of personalized disease management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Supranuclear Palsy (PSP) | – | Device: Verily Study WatchParticipants with possible or probable PSP, wearing the Verily Study Watch for 1 year. |
| Healthy Controls (HC) | – | Device: Verily Study WatchParticipants without a neurological condition, age and gender matched to the PSP cohort, , wearing the Verily Study Watch for 1 year. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PSP-cohort: any adult with PSP who meets the inclusion criteria and does not meet the exclusion criteria. HC-cohort: any adult who meets the inclusion criteria and does not meet the exclusion criteria.
Key inclusion criteria (12 listed)
- Subject has possible or probable PSP, according to the established international criteria defined by the Movement Disorders Society (MDS-PSP criteria, Höglinger et al, 2017); diagnosis is confirmed based on by consensus review process. In addition to the diagnosis of the own treating neurologist, the diagnosis always needs to be confirmed by at least one neurologist with deep expertise in movement disorders. The videotaped neurological examination as obtained during visit 1 will be used by the expert neurologist.
- Subject is an adult, at least 50 years of age.
- Subject can read and understand Dutch.
- Subject has completed the Informed Consent, as approved by the Institutional Review Board (IRB).
- Subject is willing, competent, and able to comply with all aspects of the protocol.
Key exclusion criteria (2 listed)
- Subject has an additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study.
- For Study Watch: subject is allergic to nickel.
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 |
|---|---|---|
| Verily Study WatchThe Verily Study Watch is a smartwatch, collecting physiological and/or environmental information. The sensors collect data that include movement and activity, pulse rate, skin impedance, electrocardiogram (ECG), environmental temperature, and ambient light level. | Device | Healthy Controls (HC), Progressive Supranuclear Palsy (PSP) |
Primary outcome
Annual change in digital biomarkers for gait
Time frame: From baseline till one year follow-up
Identify (a combined set of) gait-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for gait will be selected cannot be defined on forehand, as this is part of the analytical approach.
Annual change in digital biomarkers for bradykinesia
Time frame: From baseline till one year follow-up
Identify (a combined set of) bradykinesia-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for bradykinesia will be selected cannot be defined on forehand, as this is part of the analytical approach.
Annual change in digital biomarkers for falls
Time frame: From baseline till one year follow-up
Identify (a combined set of) falls-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for falls will be selected cannot be defined on forehand, as this is part of the analytical approach.
Annual change in digital biomarkers for rising from a chair
Time frame: From baseline till one year follow-up
Identify (a combined set of) features related to rising from a chair extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for rising from a chair will be selected cannot be defined on forehand, as this is part of the analytical approach.
6 secondary outcomes
Annual change in digital biomarker for motor performance
Time frame: Baseline till one year follow-up
Annual change in cognition
Time frame: Baseline till one year follow-up
Annual change in D-KEFS trail making test
Time frame: Baseline till one year follow-up
Annual change in semantic fluency
Time frame: Baseline till one year follow-up
Annual change in quality of life
Time frame: Baseline till one year follow-up
Annual change in Activities of Daily Living (ADL) performance
Time frame: Baseline till one year follow-up
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 24 Mar 2025.
- Individual participant dataSharing planned: Yes. The dataset generated in this study will become available to qualified researchers worldwide, provided research questions are approved by the Research and Data Sharing Review Committee (RDSRC). The RDSRC will protect subjects' privacy by limiting the availability of the study data and controlling access to sources of information that might potentially be used to identify the individual subjects associated with the bio-specimen analysis. The RDSRC will assess the relevance and scientific quality of research proposals for which study data or material is requested. These responsibilities include the consideration of applications for: * access to the resources obtained in this study, including data or biomaterials * applications for endorsement of a scientific project using study materials; * applications for endorsement of a clinical study using study materials.
Related trials for Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Recruiting
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
Palsy Supranuclear, Supranuclear Palsy, Progressive
RecruitingPhase 3
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
Not yet recruitingObservational study
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
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.
Bastiaan R Bloem, MD, PhD principal investigator
Radboud University Medical Center
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 Progressive Supranuclear Palsy and Brain Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
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 12 inclusion and 2 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 24 Mar 2025. 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 Netherlands. 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?
Annual change in digital biomarkers for gait (time frame: From baseline till one year follow-up). The study lists 4 primary outcomes in all. 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 24 Mar 2025.