Neuro-Degenerative DiseaseHANDDS-ONTNCT05062512
Health in Aging, Neurodegenerative Diseases and Dementias In Ontario
An observational study of Neuro-Degenerative Disease and Dementia, run by Ontario Neurodegeneration Disease Research Initiative at 1 site in Canada.
Trial summary
The Health in Aging, Neurodegenerative Diseases and DementiaS in ONTario (HANDDS-ONT) Study is an observational study that takes place in the comfort of participant's home, with no study visits occurring in a clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease, Dementia
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2021to 31 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A minimum of 500 participants from multiple groups will be recruited: those with diagnoses of neurological disorders associated with neurodegeneration and increased risk for dementia (e.g., PD, MCI/AD, cerebrovascular injury +/- cognitive impairment, ALS, Fronto-temporal dementia) as well as healthy adult aging controls
Who may be able to join
- All Participants:
- Informed Consent provided by participant or substitute decision maker
- Age 18 and older
- Participant must rate his/her level of proficiency speaking and understanding English at 7 out of 10 or higher on the a modified version of the LEAP-Q *
- Telephone or internet access
- Ability to attend a LifeLab facility of participant's choice to provide blood sample
Show all 11Show fewer
- Under the care of a primary medical care provider (e.g. family physician or nurse practitioner) and/or specialist and their name provided for purposes of reporting incidental findings.
- Participants must have proficiency in English to understand study instructions and respond to questionnaires licensed for use in English only. Study does not have resources for translation of study documents/certified translators.
- Participants with Neurodegenerative Diseases:
- Participant-reported diagnosis of meeting "possible or probable" clinical criteria for AD, MCI, PD, PD+ (e.g. MSA/PSP/CBD/LBD), ALS, FTD or Cerebrovascular disease.
- Aging adults without a specific diagnosis, but who have cognitive symptoms (Telephone Interview for Cognitive Status-Modified (TICS-M; Total score <32) will be assigned to the MCI cohort.
Who cannot join
- Underlying conditions which may interfere with the participant's ability to participate in the study or may compromise study results, including but not limited to:
- Contraindication to the biosensors as outlined by biosensor manufacturers,
- Substance abuse within the past year or history of alcohol or drug abuse which the study team feels may interfere with the participant's ability to comply with the study procedures.
- Known brain tumour (e.g. glioblastoma, metastatic cancer to the brain)
- Prior brain surgeries that the study team feels will interfere with participation
- Known history of poor venous access or difficulties with blood draws
- Significant psychiatric disorders (e.g. untreated major depression, psychosis)
Trial locations and contacts
1 site in 1 country.
About this study
The Health in Aging, Neurodegenerative Diseases and DementiaS in ONTario (HANDDS-ONT) Study is an observational study that takes place in the comfort of participant's home, with no study visits occurring in a clinic. The study is recruiting people living with a neurodegenerative disease or the effects of stroke, along with healthy, aging individuals. Studying both groups will help ONDRI researchers to:
- understand how the diseases affect different people
- discover ways to potentially detect diseases earlier
- find ways to help people manage their daily health related behaviours
Read more
Participant data is collected virtually through wearables - small sensors worn on the wrist, ankle and chest -- for 7-10 days, as participants go about their daily activities. Data is also collected from questionnaires regarding mood and quality of life. Blood samples will be collected to understand how one's genetic makeup could provide for earlier detection of some conditions, and for analysis of certain risk factors. Combining the information from the sensors (walking patterns, sleep, heart rate/rhythm, etc.), the questionnaires and the blood samples will allow researchers to better understand aging, with and without a neurodegenerative condition, over a period of time.
Participants will receive a personalized health and activity report, describing sleep and activity during the time the wearable sensors were worn. This information may help participants better understand and manage some aspects of their overall health and it can be shared with their circle of care.
Read the detailed description
HANDDS-ONT is designed with the following principal research question in mind:
Can the integration of biosamples, clinical data and remote wearable biosensor data across aging and neurodegenerative disease cohorts i) provide valuable diagnostic data, ii) demonstrate predictive utility for important clinical outcomes and iii) guide daily decisions and care for individuals living with neurodegenerative diseases? Ultimately we aim to improve the lived-experience of individuals affected by dementia. This protocol focuses on building the foundation for this long-term objective by adapting the NIA-AA framework to link genetic, proteomic, and free-living behavioural signatures across NDD cohorts.
Objectives:
Objective 1 will examine the expression of single proteins or sets of proteins (i.e., protein biomarkers), and different gene mutation inheritance patterns (e.g. mutation negative, monogenic mutation, polygenic mutations), to help identify unique cohorts with similar symptoms and free-living behavioural profiles.
Objective 2 will examine the relationship between multidimensional data (genomic-proteomic signatures, functional behaviours extracted from free-living data collected with wearable biosensors), and the risk for adverse health outcomes (e.g., ED visits, hospitalizations, long-term care admission, death, comorbid disease).
Objective 3 will examine the useability, acceptance and impact of feedback on self-management activities. Feedback around functional activities will be provided in the form of a participant report that conveys higher level metrics intended to inform and/or alter behavior relative to overall health, symptom management, and/or quality of life.
HANDDS-ONT is designed as a "Master Observational Trial" [https://doi.org/10.1016/j.cell.2019.12.009], connecting real-world clinical data with cellular, protein marker and genetic data, free-living behavioural data measured by wearable biosensors and longer-term health outcome data via linkage to administrative datasets at ICES.
Data collection will build on existing ONDRI research infrastructure and a central group of research cores that reflect the evolving state of research in neurodegenerative disorders. Specifically, there will be five complimentary research cores (Fluid biomarkers, Clinical, Wearable biosensors, Health Systems, and Neuroinformatics) overseen by a central research Administration Core.
To achieve Objective 1, fluid biomarkers from serum and plasma, genetic data, clinical information and free-living behaviours (e.g. sleep, physical activity and other markers collected using wearable biosensors) will be integrated to identify groups based on NIA-AA research framework. Participants will be asked to provide a blood sample, complete standardized questionnaires for data collection by telephone or online, and wear wearable biosensors for 7-10 days described in sections below.
To achieve Objective 2, the clinico-pathological cohorts identified in objective 1 (combining protein and genetic biomarker data with clinical and free-living behaviour data) will be linked to administrative datasets at ICES to identify risk factors for important clinical outcomes (e.g. death, long-term care need, comorbid diseases, falls) and patterns of health systems utilization. Participants will be asked for permission to securely store Health Card Numbers and link to ICES for outcomes (see Procedures and Assessments section, below).
To achieve Objective 3, surveys and interviews will be administered. As additional metrics are validated, they will be integrated into the feedback form for evaluation using the methods described in Objective 3, above. Participants may consent to being recontacted for ongoing feedback and new study options (see Procedures and Assessments section, below).
- Conditions
- Neuro-Degenerative Disease, Dementia
- Keywords
- observational, remote, wearable technology, genomics
- Medical subject headings
- Dementia
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 |
|---|---|---|
| Participants living with and without neurodegenerative diseases | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generate behavioural/functional profiles from the wearable biosensors
data collected during the biosensor wear period will be post-processed to extract additional summary measures and patterns of behaviour. Sample measures include: amount of time in sedentary/light/moderate/vigorous intensity activity, total active minutes, estimate of energy expenditure, total walking activity, step count, walking bout durations, characteristics of walking (e.g. cadence, gait velocity, etc.), imbalance and fall events, sleep duration, number of arousals, inter-daily sleep stability, intra-daily sleep variability, sleep fragmentation, heart rate (beats per minute), heart rate variability.
Measured: 7-10 day sensor wear period
identify profiles of clinical and functional expression
a semi-guided approach will identify multivariate projections using techniques such as PCA and CA from summary measures with prima facie validity of association with cognition (e.g. variability of cardiac RR interval, average total sleep time, first quartile of Fourier transform of acceleration while walking, body mass index, age) extracted from clinical eCRF and biosensor data streams.
Measured: 2 years
select subsets of genomic and proteomic features
. Multiple (mass) univariate tests will be used to rank features and false discovery rate adjustment will be used to establish feature selection threshold. Identification of multivariate associations will be performed by simultaneous models of the independent projections on the multiple genomic-proteomic features with penalized optimization. Multi-class LASSO or sparse LDA will be used to identify features associated with clinical-functional clusters.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start26 Aug 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Funding not renewed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Neurodegeneration Disease Research Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute
- Responsible party
- Sponsor
- Investigators
- Richard Swartz, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062512
- Sponsor's protocol ID
- 3589
- Acronym
- HANDDS-ONT
- Status last verified
- Apr 2024
- First submitted
- 21 Sep 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected for the purpose of publications are to be shared via a controlled public release along with accompanying data dictionaries and other supplementary files. All data share are de-identified in accordance with the policies set out by the Ontario Brain Institute (OBI).
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health in Aging, Neurodegenerative Diseases and Dementias In Ontario
- ClinicalTrials.gov ID
- NCT05062512
- Acronym / sponsor ID
- HANDDS-ONT / 3589
- Conditions
- Neuro-Degenerative Disease, Dementia
- Keywords
- observational, remote, wearable technology, genomics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding not renewed.
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ontario Neurodegeneration Disease Research InitiativeUniversity, hospital or other
- Collaborators
- Ontario Brain Institute
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 30 Sep 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.
The Health in Aging, Neurodegenerative Diseases and DementiaS in ONTario (HANDDS-ONT) Study is an observational study that takes place in the comfort of participant's home, with no study visits occurring in a clinic. The study is recruiting people living with a neurodegenerative disease or the effects of stroke, along with healthy, aging individuals. Studying both groups will help ONDRI researchers to:
- understand how the diseases affect different people
- discover ways to potentially detect diseases earlier
- find ways to help people manage their daily health related behaviours
Participant data is collected virtually through wearables - small sensors worn on the wrist, ankle and chest -- for 7-10 days, as participants go about their daily activities. Data is also collected from questionnaires regarding mood and quality of life. Blood samples will be collected to understand how one's genetic makeup could provide for earlier detection of some conditions, and for analysis of certain risk factors. Combining the information from the sensors (walking patterns, sleep, heart rate/rhythm, etc.), the questionnaires and the blood samples will allow researchers to better understand aging, with and without a neurodegenerative condition, over a period of time.
Participants will receive a personalized health and activity report, describing sleep and activity during the time the wearable sensors were worn. This information may help participants better understand and manage some aspects of their overall health and it can be shared with their circle of care.
Detailed description
HANDDS-ONT is designed with the following principal research question in mind:
Can the integration of biosamples, clinical data and remote wearable biosensor data across aging and neurodegenerative disease cohorts i) provide valuable diagnostic data, ii) demonstrate predictive utility for important clinical outcomes and iii) guide daily decisions and care for individuals living with neurodegenerative diseases? Ultimately we aim to improve the lived-experience of individuals affected by dementia. This protocol focuses on building the foundation for this long-term objective by adapting the NIA-AA framework to link genetic, proteomic, and free-living behavioural signatures across NDD cohorts.
Objectives:
Objective 1 will examine the expression of single proteins or sets of proteins (i.e., protein biomarkers), and different gene mutation inheritance patterns (e.g. mutation negative, monogenic mutation, polygenic mutations), to help identify unique cohorts with similar symptoms and free-living behavioural profiles.
Objective 2 will examine the relationship between multidimensional data (genomic-proteomic signatures, functional behaviours extracted from free-living data collected with wearable biosensors), and the risk for adverse health outcomes (e.g., ED visits, hospitalizations, long-term care admission, death, comorbid disease).
Objective 3 will examine the useability, acceptance and impact of feedback on self-management activities. Feedback around functional activities will be provided in the form of a participant report that conveys higher level metrics intended to inform and/or alter behavior relative to overall health, symptom management, and/or quality of life.
HANDDS-ONT is designed as a "Master Observational Trial" [https://doi.org/10.1016/j.cell.2019.12.009], connecting real-world clinical data with cellular, protein marker and genetic data, free-living behavioural data measured by wearable biosensors and longer-term health outcome data via linkage to administrative datasets at ICES.
Data collection will build on existing ONDRI research infrastructure and a central group of research cores that reflect the evolving state of research in neurodegenerative disorders. Specifically, there will be five complimentary research cores (Fluid biomarkers, Clinical, Wearable biosensors, Health Systems, and Neuroinformatics) overseen by a central research Administration Core.
To achieve Objective 1, fluid biomarkers from serum and plasma, genetic data, clinical information and free-living behaviours (e.g. sleep, physical activity and other markers collected using wearable biosensors) will be integrated to identify groups based on NIA-AA research framework. Participants will be asked to provide a blood sample, complete standardized questionnaires for data collection by telephone or online, and wear wearable biosensors for 7-10 days described in sections below.
To achieve Objective 2, the clinico-pathological cohorts identified in objective 1 (combining protein and genetic biomarker data with clinical and free-living behaviour data) will be linked to administrative datasets at ICES to identify risk factors for important clinical outcomes (e.g. death, long-term care need, comorbid diseases, falls) and patterns of health systems utilization. Participants will be asked for permission to securely store Health Card Numbers and link to ICES for outcomes (see Procedures and Assessments section, below).
To achieve Objective 3, surveys and interviews will be administered. As additional metrics are validated, they will be integrated into the feedback form for evaluation using the methods described in Objective 3, above. Participants may consent to being recontacted for ongoing feedback and new study options (see Procedures and Assessments section, below).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants living with and without neurodegenerative diseases | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 500 participants from multiple groups will be recruited: those with diagnoses of neurological disorders associated with neurodegeneration and increased risk for dementia (e.g., PD, MCI/AD, cerebrovascular injury +/- cognitive impairment, ALS, Fronto-temporal dementia) as well as healthy adult aging controls
Key inclusion criteria (11 listed)
- All Participants:
- Participant-reported diagnosis of meeting "possible or probable" clinical criteria for AD, MCI, PD, PD+ (e.g. MSA/PSP/CBD/LBD), ALS, FTD or Cerebrovascular disease.
- Aging adults without a specific diagnosis, but who have cognitive symptoms (Telephone Interview for Cognitive Status-Modified (TICS-M; Total score <32) will be assigned to the MCI cohort.
Key exclusion criteria (7 listed)
- Underlying conditions which may interfere with the participant's ability to participate in the study or may compromise study results, including but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Generate behavioural/functional profiles from the wearable biosensors
Time frame: 7-10 day sensor wear period
data collected during the biosensor wear period will be post-processed to extract additional summary measures and patterns of behaviour. Sample measures include: amount of time in sedentary/light/moderate/vigorous intensity activity, total active minutes, estimate of energy expenditure, total walking activity, step count, walking bout durations, characteristics of walking (e.g. cadence, gait velocity, etc.), imbalance and fall events, sleep duration, number of arousals, inter-daily sleep stability, intra-daily sleep variability, sleep fragmentation, heart rate (beats per minute), heart rate variability.
identify profiles of clinical and functional expression
Time frame: 2 years
a semi-guided approach will identify multivariate projections using techniques such as PCA and CA from summary measures with prima facie validity of association with cognition (e.g. variability of cardiac RR interval, average total sleep time, first quartile of Fourier transform of acceleration while walking, body mass index, age) extracted from clinical eCRF and biosensor data streams.
select subsets of genomic and proteomic features
Time frame: 2 years
. Multiple (mass) univariate tests will be used to rank features and false discovery rate adjustment will be used to establish feature selection threshold. Identification of multivariate associations will be performed by simultaneous models of the independent projections on the multiple genomic-proteomic features with penalized optimization. Multi-class LASSO or sparse LDA will be used to identify features associated with clinical-functional clusters.
Results and safety
The study was stopped early (reason given: Funding not renewed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. All IPD collected for the purpose of publications are to be shared via a controlled public release along with accompanying data dictionaries and other supplementary files. All data share are de-identified in accordance with the policies set out by the Ontario Brain Institute (OBI).
Related trials for Neuro-Degenerative Disease
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
RecruitingPhase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma
Enrolling by invitationObservational study
Białystok PLUS - Polish Longitudinal University Study
Cardiovascular Diseases, Diabetes
Not yet recruitingPhase 1/2
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
Multiple Sclerosis, Primary Progressive Multiple Sclerosis
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.
Richard Swartz, MD principal investigator
Sunnybrook Health Sciences Centre
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 Neuro-Degenerative Disease and Dementia, run by Ontario Neurodegeneration Disease Research Initiative at 1 site in Canada.
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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Apr 2024. 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 Canada. 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 was stopped early (reason given: Funding not renewed.). Results are not available in the source record.
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?
Generate behavioural/functional profiles from the wearable biosensors (time frame: 7-10 day sensor wear period). The study lists 3 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 2 Apr 2024.