Parkinson DiseasePPP-novoNCT04985539
The Personalized Parkinson Project De Novo Cohort
An observational study of Parkinson Disease and Parkinsonian Disorders, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases
- What is being tested?
- Verily Study Watch
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Aug 2020to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Any adult with Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria.
Who may be able to join
- Subject has Parkinson's disease of ≤2 years of duration, defined as the time since the diagnosis was made by a neurologist.
- Subject is an adult, at least 18 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, including follow-up schedule and bio-specimen collection.
- Subject has never been treated before with any symptomatic dopaminergic drug treatment for Parkinson's disease and is not expected to start treatment for motor symptoms of PD within 52 weeks from baseline.
Who cannot join
- Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
- Subject is taking Mucuna Pruriens.
- For Study Watch: subject is allergic to nickel.
Trial locations and contacts
1 site in 1 country.
About this study
Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient's day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).
Read the detailed description
This PPP de NOVO cohort aims to validate novel digital biomarkers for disease progression, fostering the unique research infrastructure and data collection protocol that are available. The PPP de NOVO cohort consists of patients with de novo (i.e., newly diagnosed and previously untreated) Parkinson's disease who will be followed longitudinally for two years. De novo patients create the opportunity to study disease progression without interference of pharmacological treatment. The observation of this natural process in the earliest course of the disease is highly relevant for the development disease modifying interventions, which are likely to have the biggest potential in the earliest phases of the disease, when the loss of substantia nigra cells is minimal. In particular, the investigators will deploy the PPP de NOVO cohort for the development of digital biomarkers that could serve as a surrogate or, with time, possibly as key secondary or even a primary outcome in future clinical trials of disease-modifying interventions. Digital biomarkers hold great promise in this regard, as they provide a means to objectively track patients and measure their function in their own living environment, unobtrusively, and over long periods of time. The outcomes are potentially more sensitive than currently available clinical scales, which also be included in the protocol and perhaps also more relevant as they provide an insight into daily life functioning over extended periods of time.
The primary objective is to develop novel digital biomarkers that allow for measurement of disease progression in de novo PD patients.
Our hypothesis is that digital progression biomarkers will have greater sensitivity and greater power for detecting disease progression than conventional scales.
The secondary objective is to test the feasibility of the Proof-Of-Concept (POC) study protocol that UCB (Union Chimique Belge) Pharma will use for their potentially disease modifying treatment. The PPP de NOVO study is considered instrumental in optimizing planning, data acquisition, analysis and interpretation of the digital data collected in the POC study.
The third objective of this study is to create an extensive longitudinal dataset describing the clinical and functional characteristics of a representative PD de novo cohort to allow researchers to investigate important unanswered questions in PD.
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Being tested
- Verily Study Watch
- Keywords
- Parkinson's Disease, Biomarkers, Wearable sensors, Disease progression
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verily Study WatchDevice
Participants wear the Verily Study Watch for 2 years, for longitudinal data collection.
| Study group | Role | What they receive |
|---|---|---|
| PD de novo | Observational. 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 de novo PD 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, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two year follow-up
Annual change in digital biomarkers for tremor
Identify (a combined set of) tremor-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for tremor will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two 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 de novo PD 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, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two year follow-up
Annual change in digital biomarkers for postural sway
Identify (a combined set of) postural sway-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for postural sway will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two year follow-up
Annual change in digital biomarkers for time active vs inactive during the day
Identify (a combined set of) features that reflect the time a person is active and inactive during the day, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for time active vs inactive during the day will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two year follow-up
Annual change in digital biomarkers for heart rate variability
Identify (a combined set of) features that reflect heart rate variability, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for heart rate variability will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two year follow-up
Annual change in digital biomarkers for skin impedance
Identify (a combined set of) features that reflect skin impedance, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for skin impedance will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Measured: From baseline till two year follow-up
Secondary outcomes (12)
Perceived feasibility of longitudinal follow-up and repeated assessments
Participants will be asked to complete an exit survey, which asks for their perception of the protocol burden (0-10 point scale)
Measured: From baseline till two year follow-up
Compliance to weekly structured tasks
Percentage of weeks in which the tasks were completed during the two-year follow-up (0-100%)
Measured: From baseline till two year follow-up
Compliance to wearing the smartwatch
Percentage of weartime during the two-year follow-up (0-100%)
Measured: From baseline till two year follow-up
Drop-out rate
Percentage of participants who withdraw their informed consent during the two-year follow-up (0-100%)
Measured: From baseline till two year follow-up
Change in PRO-Mobility
Participants will be asked to complete a 23-items Patient Reported Outcome (PRO) survey on mobility-related aspects, on a 0-4 scale. Total score ranges from 0-72.
Measured: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Mobility
Patient Global Impression of Severity (PGI-S): participants will be asked to score their perceived severity of their mobility problems over the past 7 days on a 4-point scale (none, mild, moderate, severe)
Measured: From baseline till two year follow-up, every 13 weeks
Change in PRO-Fatigue
Participants will be asked to complete a 31-items Patient Reported Outcome (PRO) survey on fatigue-related aspects, on a 0-4 scale. Total score ranges from 0-124.
Measured: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Fatigue
Patient Global Impression of Severity (PGI-S): participants will be asked to score their perceived severity level of fatigue over the past 7 days on a 4-point scale (none, mild, moderate, severe)
Measured: From baseline till two year follow-up, every 13 weeks
Change in PRO-Functional Slowness
Participants will be asked to complete a 44-items Patient Reported Outcome (PRO) survey on functional slowness-related aspects, on a 0-4 scale. Total score ranges from 0-176.
Measured: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Functional Slowness
Patient Global Impression of Severity (PGI-S): participants will be asked to score their perceived severity level of functional slowness over the past 7 days on a 4-point scale (none, mild, moderate, severe)
Measured: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Symptoms
Patient Global Impression of Severity (PGI-S): participants will be asked to score their perceived severity of their Parkinson's disease symptoms over the past 7 days on a 4-point scale (none, mild, moderate, severe)
Measured: From baseline till two year follow-up, every 13 weeks
Change in PGI-C Symptoms
Patient Global Impression of Change(PGI-S): participants will be asked to score their perceived change in severity of their Parkinson's disease symptoms since baseline on a 4-point scale (none, mild, moderate, severe)
Measured: From baseline till two year follow-up, every 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start29 Aug 2020
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Prospective
- Enrolment
- 103 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
- NCT04985539
- Sponsor's protocol ID
- NL72631.091.20
- Acronym
- PPP-novo
- Status last verified
- Mar 2025
- First submitted
- 22 Jul 2021
- 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
- The Personalized Parkinson Project De Novo Cohort
- ClinicalTrials.gov ID
- NCT04985539
- Acronym / sponsor ID
- PPP-novo / NL72631.091.20
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Keywords
- Parkinson's Disease, Biomarkers, Wearable sensors, Disease progression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UCB Pharma, Verily Life Sciences LLC
- Study start
- 29 Aug 2020 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Aug 2021 (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.
Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient's day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).
Detailed description
This PPP de NOVO cohort aims to validate novel digital biomarkers for disease progression, fostering the unique research infrastructure and data collection protocol that are available. The PPP de NOVO cohort consists of patients with de novo (i.e., newly diagnosed and previously untreated) Parkinson's disease who will be followed longitudinally for two years. De novo patients create the opportunity to study disease progression without interference of pharmacological treatment. The observation of this natural process in the earliest course of the disease is highly relevant for the development disease modifying interventions, which are likely to have the biggest potential in the earliest phases of the disease, when the loss of substantia nigra cells is minimal. In particular, the investigators will deploy the PPP de NOVO cohort for the development of digital biomarkers that could serve as a surrogate or, with time, possibly as key secondary or even a primary outcome in future clinical trials of disease-modifying interventions. Digital biomarkers hold great promise in this regard, as they provide a means to objectively track patients and measure their function in their own living environment, unobtrusively, and over long periods of time. The outcomes are potentially more sensitive than currently available clinical scales, which also be included in the protocol and perhaps also more relevant as they provide an insight into daily life functioning over extended periods of time.
The primary objective is to develop novel digital biomarkers that allow for measurement of disease progression in de novo PD patients.
Our hypothesis is that digital progression biomarkers will have greater sensitivity and greater power for detecting disease progression than conventional scales.
The secondary objective is to test the feasibility of the Proof-Of-Concept (POC) study protocol that UCB (Union Chimique Belge) Pharma will use for their potentially disease modifying treatment. The PPP de NOVO study is considered instrumental in optimizing planning, data acquisition, analysis and interpretation of the digital data collected in the POC study.
The third objective of this study is to create an extensive longitudinal dataset describing the clinical and functional characteristics of a representative PD de novo cohort to allow researchers to investigate important unanswered questions in PD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD de novo | – | Device: Verily Study WatchObservational. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult with Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria.
Key inclusion criteria (6 listed)
- Subject has Parkinson's disease of ≤2 years of duration, defined as the time since the diagnosis was made by a neurologist.
- Subject is an adult, at least 18 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, including follow-up schedule and bio-specimen collection.
Key exclusion criteria (3 listed)
- Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
- Subject is taking Mucuna Pruriens.
- 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 WatchParticipants wear the Verily Study Watch for 2 years, for longitudinal data collection. | Device | PD de novo |
Primary outcome
Annual change in digital biomarkers for gait
Time frame: From baseline till two 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 de novo PD 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, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Annual change in digital biomarkers for tremor
Time frame: From baseline till two year follow-up
Identify (a combined set of) tremor-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for tremor will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Annual change in digital biomarkers for bradykinesia
Time frame: From baseline till two 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 de novo PD 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, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Annual change in digital biomarkers for postural sway
Time frame: From baseline till two year follow-up
Identify (a combined set of) postural sway-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for postural sway will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Annual change in digital biomarkers for time active vs inactive during the day
Time frame: From baseline till two year follow-up
Identify (a combined set of) features that reflect the time a person is active and inactive during the day, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for time active vs inactive during the day will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Annual change in digital biomarkers for heart rate variability
Time frame: From baseline till two year follow-up
Identify (a combined set of) features that reflect heart rate variability, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for heart rate variability will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
Annual change in digital biomarkers for skin impedance
Time frame: From baseline till two year follow-up
Identify (a combined set of) features that reflect skin impedance, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for skin impedance will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).
12 secondary outcomes
Perceived feasibility of longitudinal follow-up and repeated assessments
Time frame: From baseline till two year follow-up
Compliance to weekly structured tasks
Time frame: From baseline till two year follow-up
Compliance to wearing the smartwatch
Time frame: From baseline till two year follow-up
Drop-out rate
Time frame: From baseline till two year follow-up
Change in PRO-Mobility
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Mobility
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PRO-Fatigue
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Fatigue
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PRO-Functional Slowness
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Functional Slowness
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PGI-S Symptoms
Time frame: From baseline till two year follow-up, every 13 weeks
Change in PGI-C Symptoms
Time frame: From baseline till two year follow-up, every 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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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 Parkinson Disease and Parkinsonian Disorders, 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 6 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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 two year follow-up). The study lists 7 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.