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Alzheimer DiseaseONDRINCT04104373

The Ontario Neurodegenerative Disease Research Initiative

An observational study of Alzheimer Disease and Amyotrophic Lateral Sclerosis, run by Ontario Neurodegeneration Disease Research Initiative at 12 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 55 to 85 years
What is being tested?
Observational Cohort
How many people
522 participants
Where
12 sitesCanada
Study dates
7 Jul 2014to 30 Apr 2018
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 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
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  • 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.).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Canada12 sites

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, L8L 8E7

  • Providence Care Mental Health Services

    Kingston, Ontario, K7L 5A2

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Parkwood Institute

    London, Ontario, N6C 0A7

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Elisabeth Bruyere

    Ottawa, Ontario, K1N 5C8

  • Thunder Bay Regional Research Institute

    Thunder Bay, Ontario, P7B 5E1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network

    Toronto, Ontario, M5T 2S8

  • Baycrest

    Toronto, Ontario, M6A 2Ei

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4

Other trials in Canada

About this study

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)
Read the 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.

Being tested
Observational Cohort
Medical subject headings
Alzheimer Disease, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson Disease, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational CohortOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 Years

  2. 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

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. 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.

    Measured: 5 years

  5. 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.

    Measured: 5 years

  6. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start7 Jul 2014
  3. Primary completion31 Mar 2018
  4. Study completion30 Apr 2018

Resources

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
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04104373
Sponsor's protocol ID
ONDRI2013
Acronym
ONDRI
Status last verified
Apr 2024
First submitted
21 Mar 2016
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 41059602

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Amyotrophic Lateral Sclerosis, run by Ontario Neurodegeneration Disease Research Initiative at 12 sites 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 12 inclusion and 10 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: finished, 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 12 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Eye Tracking - Pro Saccade and Anti Saccade (time frame: 5 Years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104373, which also lists 1 linked publication.

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.

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