Social Cognition and Personality Changes in Alzheimer's & Parkinson's Disease & Frontotemporal Lobar Degeneration

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease; Frontotemporal Lobar Degeneration; Alzheimer's Disease
• Intervention / Treatment: Behavioral: Observational Study

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Cristina Salvo, BSc, MD; Phone Number: 416-507-6880; Email: cristina.salvo@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital, University Health Network
      • Contact: Carmela Tartaglia, MD; Phone Number: 4166035483; Email: carmela.tartaglia@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of Alzheimer's disease, Parkinson's disease or Frontotemporal Lobar Degeneration

Description

Inclusion Criteria:

Patients:

• 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)

Patients:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alzheimer's disease; Observational Study	Behavioral: Observational Study; This is an observational study.
Parkinson's disease; Observational Study	Behavioral: Observational Study; This is an observational study.
Frontotemporal Lobar Degeneration; Observational Study	Behavioral: Observational Study; This is an observational study.
Healthy Controls; Observational Study	Behavioral: Observational Study; This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD	Assesses interpersonal aspects of personality	one time visit, through study completion of 3 years
Personality via the Behaviour Inhibition/Approach Scale (BIS/BAS) and differences between AD, PD, and FTLD	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	one time visit, through study completion of 3 years
Personality via the Big Five Inventory (BFI) and differences between AD, PD, and FTLD	Assesses the patient's Big Five dimensions (openness, conscientiousness, extraversion, agreeableness, and neuroticism) with respect to past and current behavior	one time visit, through study completion of 3 years
Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD	Assesses the patient's understanding of culturally relevant social norms	one time visit, through study completion of 3 years
Social cognition via Interpersonal Reactivity Index (IRI) and differences between AD, PD, and FTLD	Assesses the patient's empathy or ability to share in another's mental and emotional experience	one time visit, through study completion of 3 years
Social cognition via Revised Self-Monitoring Scale (RSMS) and differences between AD, PD, and FTLD	Assesses the patient's sensitivity to the expressive behaviour of others and their ability to monitor their self-presentation	one time visit, through study completion of 3 years
Social cognition via Social Behaviour Observer Checklist and differences between AD, PD, and FTLD	Assesses behaviors specific to behavioural variant Frontotemporal Dementia (bvFTD) and is helpful in differentiating bvFTD versus Alzheimer's disease.	one time visit, through study completion of 3 years
Neuropsychiatric Inventory (NPI) and differences between AD, PD, and FTLD	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	one time visit, through study completion of 3 years
Clinical Dementia Rating Scale (CDR) and differences between AD, PD, and FTLD	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	one time visit, through study completion of 3 years
Functional Activities Questionnaire (FAQ) and differences between AD, PD, and FTLD	Assesses functional capacity in older adults	one time visit, through study completion of 3 years
Behavioural Tests composite score and differences between AD, PD, and FTLD	Orientation, Digit span backward and forward, Naming, Modified trails, Benson figure copy, Cerad, Clock draw	one time visit, through study completion of 3 years
Emotion Evaluation Task (EET) portion of The Awareness of Social Inference Test and differences between AD, PD, and FTLD	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.	one time visit, through study completion of 3 years
Geriatric Depression Scale (GDS) and differences between AD, PD, and FTLD	Assesses mood and depression in geriatric patients	one time visit, through study completion of 3 years
Neuroimaging and differences between AD, PD, and FTLD	Functional connectivity of networks associated with social cognition and personality	one time visit, through study completion of 3 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Maria C Tartaglia, M.D., Toronto Western Hospital, UHN; Tanz CRND

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Tauopathies; Parkinson Disease; Alzheimer Disease; Frontotemporal Lobar Degeneration
• Other Study ID Numbers: 12-0451-BE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO