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Clinical Trials/NCT02964611
NCT02964611
Completed
N/A

Assessing Changes in Social Cognition and Personality in Patients with Frontotemporal Lobar Degeneration, Alzheimer's Disease and Parkinson's Disease and Their Effect on the Patient-caregiver Relationship

University Health Network, Toronto1 site in 1 country120 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
University Health Network, Toronto
Enrollment
120
Locations
1
Primary Endpoint
Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to compare personality and social cognition changes, including emotion detection and self-awareness, and neuroanatomical correlates in patients, and how that affects the caregiver-patient relationship.

Detailed Description

The purpose of this study is to understand social cognition changes in patients with Alzheimer's disease (AD), Parkinson's disease (PD), and Frontotemporal Lobar Degeneration (FTLD), which includes Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS) and Frontotemporal Dementia (FTD - behavioural variant frontotemporal dementia, progressive non-fluent aphasia and semantic dementia), and the effect of these changes on the patients' relationship with their caregivers. In addition, the study aims to provide a greater clarity in the neuroanatomical correlates of social cognition in patients with FTLD, PD and AD.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
August 16, 2016
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmela Tartaglia

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

Inclusion Criteria

  • ability to speak and understand the English language (as questionnaires and tests are only available in English)
  • Caregivers:
  • primary caregiver for a given patient
  • ability to speak and understand the English language (as questionnaires and tests are only available in English)

Exclusion Criteria

  • Patients and Caregivers:
  • history of another neurological disorder
  • psychiatric disorder
  • severe aphasia (semantic word loss)
  • visual deficits requiring correction beyond the use of eyeglasses or contact lenses (intact visual acuity is required for completing both the questionnaires and the emotion evaluation test which consists of video vignettes)
  • auditory deficits requiring correction beyond hearing aids (videos have auditory component)
  • presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body will be excluded as they will be unable to have a MRI scan.
  • premenopausal women will be excluded due to the unknown risk of MRIs during pregnancy.

Outcomes

Primary Outcomes

Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses the patient's understanding of culturally relevant social norms

Emotion Evaluation Task (EET) portion of The Awareness of Social Inference Test and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses the recognition of six basic emotions commonly recognized across cultures (happiness, sadness, anger, surprise, disgust, fear) as well as a seventh "neutral" emotion. The emotions are presented via video vignettes. After viewing each scene, the patient will be asked to choose the emotion represented from a list of seven emotional categories. The caregiver will complete the test separately, and be asked both to guess the emotion in each vignette, and to speculate on which emotion the patient will guess.

Personality via the Behaviour Inhibition/Approach Scale (BIS/BAS) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses the behavioural approach system that regulates appetitive motives, in which the goal is to move toward something desired, and the behavioural avoidance (or inhibition) system that regulates aversive motives, in which the goal is to move away from something unpleasant

Social cognition via Revised Self-Monitoring Scale (RSMS) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses the patient's sensitivity to the expressive behaviour of others and their ability to monitor their self-presentation

Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses interpersonal aspects of personality

Personality via the Big Five Inventory (BFI) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses the patient's Big Five dimensions (openness, conscientiousness, extraversion, agreeableness, and neuroticism) with respect to past and current behavior

Social cognition via Interpersonal Reactivity Index (IRI) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses the patient's empathy or ability to share in another's mental and emotional experience

Geriatric Depression Scale (GDS) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses mood and depression in geriatric patients

Neuroimaging and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Functional connectivity of networks associated with social cognition and personality

Social cognition via Social Behaviour Observer Checklist and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses behaviors specific to behavioural variant Frontotemporal Dementia (bvFTD) and is helpful in differentiating bvFTD versus Alzheimer's disease.

Neuropsychiatric Inventory (NPI) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses 12 neuropsychiatric disturbances commonly encountered in patients with dementia, including: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behaviour, night-time behaviour disturbances, and appetite and eating abnormalities

Functional Activities Questionnaire (FAQ) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses functional capacity in older adults

Behavioural Tests composite score and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Orientation, Digit span backward and forward, Naming, Modified trails, Benson figure copy, Cerad, Clock draw

Clinical Dementia Rating Scale (CDR) and differences between AD, PD, and FTLD

Time Frame: one time visit, through study completion of 3 years

Assesses 8 domains of global dementia, including: memory, orientation, judgment/problem solving, community affairs, home and hobbies, personal care, behavioural comportment and personality, and language

Study Sites (1)

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