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

NCT02964611 | Completed

• 1 other identifier: 12-0451-BE
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Parkinson's Disease; Frontotemporal Lobar Degeneration

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (4)

Alzheimer's disease

Observational Study

Behavioral: Observational Study

Parkinson's disease

Observational Study

Behavioral: Observational Study

Frontotemporal Lobar Degeneration

Observational Study

Behavioral: Observational Study

Healthy Controls

Observational Study

Behavioral: Observational Study

Interventions

Observational Study BEHAVIORAL

This is an observational study.

Alzheimer's disease; Frontotemporal Lobar Degeneration; Healthy Controls; Parkinson's disease

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Frontotemporal Lobar Degeneration

Interventions

Observation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Maria C Tartaglia, M.D.

  Toronto Western Hospital, UHN; Tanz CRND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: November 16, 2016
• Study Start: January 1, 2013
• Primary Completion: August 16, 2016
• Study Completion: August 16, 2016
• Last Updated: December 18, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)