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

This study is currently recruiting participants.
Verified October 2017 by Carmela Tartaglia, University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT02964611
First Posted: November 16, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Carmela Tartaglia, University Health Network, Toronto
  Purpose
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 Intervention
Alzheimer's Disease Parkinson's Disease Frontotemporal Lobar Degeneration Behavioral: Observational Study

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Carmela Tartaglia, University Health Network, Toronto:

Primary Outcome Measures:
  • 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 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

  • 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 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of Alzheimer's disease, Parkinson's disease or Frontotemporal Lobar Degeneration
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964611


Contacts
Contact: Namita Multani, MSc 416-507-6880 namita.multani@mail.utoronto.ca

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Carmela Tartaglia, MD    4166035483    carmela.tartaglia@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Maria C Tartaglia, M.D. Toronto Western Hospital, UHN; Tanz CRND
  More Information

Responsible Party: Carmela Tartaglia, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02964611     History of Changes
Other Study ID Numbers: 12-0451-BE
First Submitted: September 23, 2016
First Posted: November 16, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Frontotemporal Lobar Degeneration
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases