The Ontario Neurodegenerative Disease Research Initiative

Plain-language summary

This is an observational cohort study that follows people with neurodegenerative diseases, including Alzheimer's, ALS, frontotemporal dementia, Parkinson's disease, and vascular cognitive impairment. People diagnosed with one of these diseases who had sufficient English proficiency and a reliable study partner could take part. It was carried out as an observational study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Ontario Neurodegeneration Disease Research Initiative

Intervention

Observational Cohort

Start date

7/7/2014

Estimated completion

4/30/2018

Countries

Canada

Related genes

Locations

• Hamilton, Canada
• Kingston, Canada
• London, Canada
• London, Canada
• Ottawa, Canada
• Ottawa, Canada
• Thunder Bay, Canada
• Toronto, Canada
• Toronto, Canada
• Toronto, Canada
• Toronto, Canada
• Toronto, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.