The Ontario Neurodegenerative Disease Research Initiative

NCT04104373 | Completed DMC

• 1 other identifier: ONDRI2013
• Study Type: observational
• Target: 522
• Locations: 1 country
• Sites: 12

Brief Summary

The Ontario Neurodegenerative Disease Research Initiative (ONDRI) is a province-wide collaboration studying dementia and how to improve the diagnosis and treatment of neurodegenerative diseases including:

• Alzheimer's disease (AD)
• Parkinson's disease (PD)
• amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease)
• frontotemporal lobar degeneration (FTD)
• vascular cognitive impairment, resulting from stroke (VCI)

Conditions

Alzheimer Disease; Amyotrophic Lateral Sclerosis; Frontotemporal Dementia; Parkinson Disease; Stroke

Outcome Measures

Primary Outcomes (6)

• Eye Tracking - Pro Saccade and Anti Saccade

  Pro-saccade task assesses simple sensory-motor function by following eye movement for specific tasks. • Anti-saccade task is identical to the pro-saccade task, except the instruction, indicated by fixation point (FP) colour,and is a sensitive indicator of cognitive disturbances.

  5 Years

• Retinal Nerve Imaging

  Institutions with the Heidelberg Spectralis with Ocular Coherence Tomography (OCT) Blue Peak Instrumentation will participate in this assessment. Both eyes of all participants will undergo: * Assessment of best corrected visual acuity * Digital colour fundus photography. * Retinal nerve imaging

  5 years

• Gait and Balance

  All participants will perform walks along a 6 metre path while wearing hip and ankle accelerometers. Participants will perform three main tasks: 1) preferred walking speed, 2) dual task walking and 3) fast walking.

  5 years

• Genomics

  Blood samples will be drawn by LifeLabs Medical Laboratory Services located in London, Ottawa, Toronto, Kingston, Thunder Bay, and Hamilton. Under extenuating circumstances, an appointment may be made with LifeLabs to have the blood samples drawn at home or in a residential facility.Samples must be drawn from Monday to Wednesday to allow for weekday shipping and receipt of samples at the OBI Biobank Sample Reception at Robarts Research Institute in London, Ontario (ON). LifeLabs standardized protocols for collection and overnight shipping will be followed. Subsequently, DNA aliquots for NeuroX microarray will be sent to Dr. Ekaterina Rogaeva at the University of Toronto in Toronto, ON. DNA aliquots for the OBI Neurodegeneration Re-sequencing Panel will remain with Dr. Robert Hegele at Robarts Research Institute in London, ON.

  5 years

• Neuropsychology

  A battery of broad-based, standardized and validated cognitive assessments covering attention,memory, speech production, language and visuospatial function with a focus on coginitve domains reflection frontal network functioning and social attention. will be completed on an annual basis.

  5 years

• Neuroimaging

  Imaging will be done on an annual basis to characterize the neuro-anatomical, microstructural, and functional profiles of dementia types and monitor changes from baseline.

  5 years

Interventions

Observational Cohort OTHER

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately six hundred (600) participants who have one of the following diseases: VCI (150), AD/MCI (150); PD (150); FTD (60) and ALS (90) are to be enrolled.

You may qualify if:

• Written informed consent must be obtained and documented.
• Participant must rate his/her level of proficiency in speaking and understanding English at 7 out of 10 or higher on the two LEAP-Q questions.
• Participant must have ≥ 8 years education.
• Participant with a minimum MoCA score of ≥18.
• Exception: FTD minimum MoCA score of ≥ 14.
• Participant must have a reliable Study Partner. The Study Partner must:
• Interact regularly with the participant (i.e., have contact with the participant at least once a month over the phone, email, or face-to-face);
• Know the participant well enough to answer questions about the her/his cognitive abilities, communication skills, mood, and daily functioning (i.e., known the participant for at least 2 years);
• Provide written informed consent and complete study questionnaires;
• Be willing and able to assist in compliance with study procedures (if required).
• Geographic accessibility to the study site.
• Participant must be able to walk (assistive aids may be used, e.g., cane, walker, etc.).

You may not qualify if:

• Serious underlying disease other than the disease being studied which in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.
• Any disease that would/could lead to death over the next 3 to 5 years (i.e., cardiac/renal/liver cancer) with poor prognosis.
• Participant has been diagnosed with more than one of the five diseases (AD/MCI, ALS, FTD, PD or VCI) being studied.
• History of alcohol or drug abuse, which in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
• Presence of any of the following clinical conditions:
• Substance abuse within the past year.
• Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease.
• AIDS or AIDS-related complex.
• Unstable psychiatric illness defined as psychosis (hallucinations or delusions) or untreated major depression within 90 days of the screening visit.
• Participant is currently enrolled in a disease modifying therapeutic (drug or interventional) trial or observational study that the Executive Committee feels would compromise study results.

Sponsors & Collaborators

• Ontario Neurodegeneration Disease Research Initiative: lead

Study Sites (12)

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L 8E7, Canada

Location

Providence Care Mental Health Services

Kingston, Ontario, K7L 5A2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Parkwood Institute

London, Ontario, N6C 0A7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Elisabeth Bruyere

Ottawa, Ontario, K1N 5C8, Canada

Location

Thunder Bay Regional Research Institute

Thunder Bay, Ontario, P7B 5E1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Baycrest

Toronto, Ontario, M6A 2Ei, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (1)

• Ryoo SW, Lin WZ, Magliocco A, Ruthirakuhan M, Wong YY, Perfetto SE, Huang C, Anita NZ, Arnott SR, Lang AE, Symons S, Hegele RA, Goubran M, Ramirez J, Ottoy J, Rabin JS, MacIntosh BJ, Lanctot KL, Liang N, Cogo-Moreira H, Taha AY, Swardfager W; ONDRI Investigators. Metabolic and vascular contributions to dementia: Soluble epoxide hydrolase-derived linoleic acid oxylipins and glycemic status are related to cerebral small vessel disease markers, atrophy, and cognitive performance. Alzheimers Dement. 2025 Oct;21(10):e70718. doi: 10.1002/alz.70718.

  PMID: 41059602 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood for genomic analysis of Deoxyribonucleic Acid (DNA) for rare variant genes potentially predictive of dementias.

MeSH Terms

Conditions

Alzheimer Disease; Amyotrophic Lateral Sclerosis; Frontotemporal Dementia; Parkinson Disease; Stroke

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Frontotemporal Lobar Degeneration; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

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: March 21, 2016
• First Posted: September 26, 2019
• Study Start: July 7, 2014
• Primary Completion: March 31, 2018
• Study Completion: April 30, 2018
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Initial data release of Baseline data was made available June 8, 2022. Further release of longitudinal data and raw, de-identified neuroimaging data will be made available on September 30, 2023.
• 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 (12)