Status:
COMPLETED
The Ontario Neurodegenerative Disease Research Initiative
Lead Sponsor:
Ontario Neurodegeneration Disease Research Initiative
Conditions:
Alzheimer Disease
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
55-85 years
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 includ...
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 diagn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT04104373
Start Date
July 7 2014
End Date
April 30 2018
Last Update
April 2 2024
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 8E7
2
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L 5A2
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
4
Parkwood Institute
London, Ontario, Canada, N6C 0A7