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Health in Aging, Neurodegenerative Diseases and Dementias In Ontario (HANDDS-ONT)

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ClinicalTrials.gov Identifier: NCT05062512
Recruitment Status : Recruiting
First Posted : September 30, 2021
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
Ontario Brain Institute
Information provided by (Responsible Party):
Ontario Neurodegeneration Disease Research Initiative

Brief 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. 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:

  1. understand how the diseases affect different people
  2. discover ways to potentially detect diseases earlier
  3. 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.


Condition or disease
Neuro-Degenerative Disease Dementia

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health in Aging, Neurodegenerative Diseases and Dementias In Ontario
Actual Study Start Date : August 26, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Participants living with and without neurodegenerative diseases
No intervention



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA

Collected samples (serum, plasma, DNA, RNA) will be used for analyses including, but not limited to:

  • total tau protein, phosphorylated tau-181 (p-tau181), neurofilament light chain (NfL), glial fibrillary acidic protein (GFAp), Neuron-specific enolase (NSE), S100 calcium-binding protein B (S100B), amyloid beta 40 and 42 (AB-40, AB-42), alpha-synuclein markers.
  • additional emerging approaches (e.g. lipidomics, RNA analysis) help to understand processes of aging, vascular risk, inflammation and other factors that can accelerate decline and/or promote health.
  • whole genome sequencing will be performed to identify potential genetic variants that may predict underlying neurodegenerative disease and dementia.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • All Participants:

    1. Informed Consent provided by participant or substitute decision maker
    2. Age 18 and older
    3. 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 *
    4. Telephone or internet access
    5. Ability to attend a LifeLab facility of participant's choice to provide blood sample
    6. 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:

  1. 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.
  2. 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.

Exclusion Criteria:

  • 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:

    1. Contraindication to the biosensors as outlined by biosensor manufacturers,
    2. 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.
    3. Known brain tumour (e.g. glioblastoma, metastatic cancer to the brain)
    4. Prior brain surgeries that the study team feels will interfere with participation
    5. Known history of poor venous access or difficulties with blood draws
    6. Significant psychiatric disorders (e.g. untreated major depression, psychosis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062512


Contacts
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Contact: Natalie Rashkovan 416-480-6100 ext 83724 natalie.rashkovan@sunnybrook.ca
Contact: Ashley Wilcox 416-480-6661 ashley.wilcox@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Natalie Rashkovan    416-480-6100 ext 84735    natalie.rashkovan@sunnybrook.ca   
Contact: Ashley Wilcox    416-480-6661    ashley.wilcox@sunnybrook.ca   
Sponsors and Collaborators
Ontario Neurodegeneration Disease Research Initiative
Ontario Brain Institute
Investigators
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Principal Investigator: Richard Swartz, MD Sunnybrook Health Sciences Centre
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Responsible Party: Ontario Neurodegeneration Disease Research Initiative
ClinicalTrials.gov Identifier: NCT05062512    
Other Study ID Numbers: 3589
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ontario Neurodegeneration Disease Research Initiative:
observational
remote
wearable technology
genomics
Additional relevant MeSH terms:
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Dementia
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders