The Ontario Neurodegenerative Disease Research Initiative (ONDRI)

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)

Study Overview

• Status: Completed
• Conditions: Stroke; Parkinson Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease; Frontotemporal Dementia
• Intervention / Treatment: Other: Observational Cohort

Detailed Description

The Ontario Neurodegenerative Disease Research Initiative (ONDRI) is a research program designed to investigate similarities and differences of dementia among five diseases that will improve the diagnosis and treatment of neurodegeneration. The focus is on diseases that are associated with dementia: Alzheimer's disease/mild cognitive impairment, Parkinson's disease, amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), frontotemporal lobar degeneration, and vascular cognitive impairment (resulting from stroke).

ONDRI is a province-wide collaboration between more than 50 of Ontario's world-class neurodegenerative disease researchers and clinicians, four patient advocacy groups, the industrial sector, and more than 20 clinical, academic and research centres carried out in partnership with the Ontario Brain Institute (OBI).

Instead of only studying what's unique, our long-term observational study is seeking out the common early indicators and risk factors of the five diseases.

Our mandate is to ensure that the findings from the data collected are transformed into new diagnostic methods that will help detect diseases earlier, improved clinical practice that puts patients first, and eventually new effective treatments that will slow the diseases from progressing or even prevent the disease so people can continue to enjoy the later years of their lives.

More than 600 participants will be followed for up to three years and will complete assessments for genomics, gait and balance, eye measurements, neuropsychology, and neuroimaging and will donate their data to a comprehensive integrated data management system called Brain-CODE.

• Study Type: Observational
• Enrollment (Actual): 522

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Hamilton Health Sciences Centre
    • Kingston, Ontario, Canada, K7L 5A2
      • Providence Care Mental Health Services
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • London, Ontario, Canada, N6C 0A7
      • Parkwood Institute
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Ottawa, Ontario, Canada, K1N 5C8
      • Elisabeth Bruyere
    • Thunder Bay, Ontario, Canada, P7B 5E1
      • Thunder Bay Regional Research Institute
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M6J 1H4
      • Centre for Addiction and Mental Health
    • Toronto, Ontario, Canada, M5T 2S8
      • University Health Network
    • Toronto, Ontario, Canada, M6A 2Ei
      • Baycrest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ontario Neurodegeneration Disease Research Initiative
• Investigators: Principal Investigator: Richard Swartz, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2014
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neuromuscular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Parkinson Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease; Neurodegenerative Diseases; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: ONDRI2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected for the purpose of publications are to be shared via a controlled public release along with the accompanying data dictionaries and other supplementary files. All data shared are de-identified in accordance with the policies set out by the Ontario Brain Institute (OBI).
• IPD Sharing 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.
• IPD Sharing 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.