Health in Aging, Neurodegenerative Diseases and Dementias In Ontario

NCT05062512 | Terminated

• 1 other identifier: 3589
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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. 1.understand how the diseases affect different people
2. 2.discover ways to potentially detect diseases earlier
3. 3.find ways to help people manage their daily health related behaviours

Conditions

Neuro-Degenerative Disease; Dementia

Keywords

observational; remote; wearable technology; genomics

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 years

Study Arms (1)

Participants living with and without neurodegenerative diseases

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ontario Neurodegeneration Disease Research Initiative: lead
• Ontario Brain Institute: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Richard Swartz, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: August 26, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be released in the future and available with supporting information per OBI's guidelines.
• Access Criteria: Access to data is provided to users with an affiliation with an accredited academic institution, think tank, company, or other research organization. Users must also submit a Data Access Request along with Research Ethics Board approval which are then reviewed and approved by OBI's data access committee.

Locations

CA (1)