Clinical trial NCT04104373: The Ontario Neurodegenerative Disease Research Initiative
Official title: The Ontario Neurodegenerative Disease Research Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Amyotrophic Lateral Sclerosis
Frontotemporal Dementia
Parkinson Disease
Stroke
Lead sponsor: Ontario Neurodegeneration Disease Research Initiative
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 522
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eye Tracking - Pro Saccade and Anti Saccade
timeFrame: 5 Years
measure: Retinal Nerve Imaging
timeFrame: 5 years
measure: Gait and Balance
timeFrame: 5 years
measure: Genomics
timeFrame: 5 years
measure: Neuropsychology
timeFrame: 5 years
measure: Neuroimaging
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: Kingston
country: Canada
facility: Providence Care Mental Health Services
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Elisabeth Bruyere
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Richard Swartz, MD
role: PRINCIPAL_INVESTIGATOR
References: