The Ontario Neurodegenerative Disease Research Initiative

Stroke Clinical Trial

— ONDRI  

Official title:

The Ontario Neurodegenerative Disease Research Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104373
• Other study ID #: ONDRI2013
• Status: Completed
• Start date: July 7, 2014
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2024
• Source: Ontario Neurodegeneration Disease Research Initiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

• frontotemporal lobar degeneration (FTD)

• vascular cognitive impairment, resulting from stroke (VCI)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: April 30, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyotrophic Lateral Sclerosis
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Motor Neuron Disease
• Neurodegenerative Diseases
• Parkinson Disease
• Pick Disease of the Brain
• Stroke

Intervention

Other:
• Observational Cohort

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Providence Care Mental Health Services	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Parkwood Institute	London	Ontario
Canada	Elisabeth Bruyere	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Thunder Bay Regional Research Institute	Thunder Bay	Ontario
Canada	Baycrest	Toronto	Ontario
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Neurodegeneration Disease Research Initiative

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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