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Completed

NCT Number: NCT02964611

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies TDP-43 Proteinopathies Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational study

Behavioral

This is an observational study.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2016
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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