Ontario Nörodejeneratif Hastalık Araştırma Girişimi

Sade dilde özet

Bu çalışma, nörodejeneratif hastalıkları (neurodegenerative disease) olan bireyleri izleyen gözlemsel bir kohort araştırmasıdır; Alzheimer, ALS, frontotemporal demans (frontotemporal dementia), Parkinson hastalığı veya vasküler bilişsel bozukluk (vascular cognitive impairment) gibi hastalıkları incelemektedir. Bu hastalıklardan biriyle tanı almış, yeterli İngilizce ve güvenilir bir çalışma partneri olan bireyler katılabilmiştir. Çalışma faz uygulanmayan bir gözlemsel çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

Ontario Neurodegeneration Disease Research Initiative

Müdahale

Observational Cohort

Başlangıç

07.07.2014

Tahmini bitiş

30.04.2018

Ülkeler

Canada

İlgili genler

Merkezler

• 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

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.