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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT02964611
Collaborator
(none)
120
1
83
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
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
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD [one time visit, through study completion of 3 years]

    Assesses interpersonal aspects of personality

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

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

  4. Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD [one time visit, through study completion of 3 years]

    Assesses the patient's understanding of culturally relevant social norms

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

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

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

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

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

  10. Functional Activities Questionnaire (FAQ) and differences between AD, PD, and FTLD [one time visit, through study completion of 3 years]

    Assesses functional capacity in older adults

  11. Behavioural Tests composite score and differences between AD, PD, and FTLD [one time visit, through study completion of 3 years]

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

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

  13. Geriatric Depression Scale (GDS) and differences between AD, PD, and FTLD [one time visit, through study completion of 3 years]

    Assesses mood and depression in geriatric patients

  14. Neuroimaging and differences between AD, PD, and FTLD [one time visit, through study completion of 3 years]

    Functional connectivity of networks associated with social cognition and personality

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital, University Health Network Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Maria C Tartaglia, M.D., Toronto Western Hospital, UHN; Tanz CRND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carmela Tartaglia, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02964611
Other Study ID Numbers:
  • 12-0451-BE
First Posted:
Nov 16, 2016
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2019