Longitudinal Study of Mild Cognitive Impairment in Parkinson's Disease

NCT02637089 | Unknown

• 1 other identifier: REB14-2463
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Identify which structures in the brain exhibit the highest structural changes and / or BOLD changes correlated to the Z-scores of the neuropsychological assessments

  Structural changes and changes in BOLD fMRI sequence will be measured at each of the three time points. These measurements will be correlated to the Z-scores of the neuropsychological assessments at each time point.

  Baseline, 18 months, 36 months

Secondary Outcomes (9)

• Change from baseline in Z-scores of different neuropsychological assessments

  Baseline, 18 months, 36 months

• Change in Cognitive Ability measured as BOLD fMRI sequence

  Baseline, 18 months, 36 months

• Change in Executive Functioning measured as BOLD fMRI sequence

  Baseline, 18 months, 36 months

• Measure changes in the volume of subcortical structures in the brain

  Baseline, 18 months, 36 months

• Measure changes in cortical thickness in the brain

  Baseline, 18 months, 36 months

Study Arms (4)

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)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Parkinson's disease with and without mild cognitive impairment, patients without Parkinson's disease with and without (healthy controls) mild cognitive impairment, 60 years of age or older

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Montreal Neurological Institute and Hospital: collaborator
• McGill University: collaborator

Study Sites (1)

University of Calgary, Department of Clinical Neurosciences

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

60 ml of blood will be collected from all participants to analyze biomarkers and DNA for genes of interest

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Oury Monchi, PhD

  University of Calgary, Cumming School of Medicine, Department of Clinical Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Kathol, PhD

CONTACT

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

Lorelei Tainsh, RN, CRC

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: December 22, 2015
• Study Start: March 28, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

CA (1)