Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT02637089

Conditions

Parkinson's Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Parkinson's disease (PD) is known for its motor symptoms and affects more than 100,000 Canadians. However, PD patients also show cognitive deficits and neuropsychiatric problems that significantly impair their quality of life. The occurrence of dementia in PD is much higher than in the general population. The proposed study will allow the principal investigator, his team and his collaborators to investigate the origins and evolution of the cognitive and neuropsychiatric symptoms. Participants with PD with and without mild cognitive impairment (MCI) and participants with and without MCI over the age of 60 years will be assessed during eight study visits over three years. Through brain imaging, clinical testing, as well as genotyping the cognitive patterns in the four different groups will be observed and compared. The results will be used to identify biomarkers that can predict the occurrence of dementia early in the disease. Ultimately, the results of the proposed research will contribute to interventions and treatment strategies tailored to different cognitive profiles in PD before the occurrence of dementia.

Conditions

Parkinson's Disease

Mild Cognitive Impairment

Study ID

NCT02637089

Start date

Mar 28, 2016

Status verified date

Oct, 2020

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

Cases:

  • Non-demented PD patients at stages II or III of Hoehn and Yahr at Time point 1 with or without MCI
  • MCI patients
  • Willing and able to provide written informed consent
  • Willing to provide blood sample, willing to participate in all clinical assessments, willing to have brain MRIs

Controls:

  • Community volunteers, with no history of PD or cognitive or memory complaints
  • Willing and able to provide written informed consent
  • Willing to provide blood sample, willing to participate in all clinical assessments, willing to have brain MRIs
  • Screen negative for MCI

Exclusion Criteria:

•All participants who meet the diagnosis of dementia at Time point 1 as indicated by Mini-Mental State Evaluation (MMSE) of 20 or less and indicated through the clinical testing.

(The neuropsychological evaluation will always take place before the imaging sessions, in case participants must be excluded based on their cognitive profile.)

  • All participants taking benzodiazepines will be excluded as these can severely impair performance of cognitive tasks.
  • Participants with metallic objects in their bodies will not be eligible for the study because the strong magnetic field in the scanner could cause these objects to change position and may cause injury.
  • The following criteria will also be used as grounds for exclusion, as they have severe impact on cognitive function:

  • Alcohol-dependency
  • Presence or history of severe psychiatric disorder, neurological disorder or stroke
  • General anaesthesia in the past six months
  • History of cerebrovascular disorders

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

PD-non-MCI

Patients with Parkinson's disease, no mild cognitive impairment

PD-MCI

Patients with Parkinson's disease with mild cognitive impairment

MCI (non-PD-MCI)

Patients with mild cognitive impairment, no Parkinson's disease

HC (non-PD-non-MCI)

Healthy Controls (age-matched to patients)

Primary outcome measure

  • Identify which structures in the brain exhibit the highest structural changes and / or BOLD changes correlated to the Z-scores of the neuropsychological assessments [ Time Frame: Baseline, 18 months, 36 months ]

Central Contacts and Locations

Central contacts

Iris Kathol, PhD

1-403-210-6830ikathol@ucalgary.ca

Lorelei Tainsh, RN, CRC

1-403-220-8413derwent@ucalgary.ca

Locations

University of Calgary, Department of Clinical Neurosciences

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Iris Kathol, PhD

1-403-210-6830ikathol@ucalgary.ca

Nadia Maarouf, PhD

1-403-210-8519nmaarouf@ucalgary.ca

Principal Investigator:

Oury Monchi, PhD

More Information

Sponsor

University of Calgary

Last update posted

Nov 2, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2020-11-02.