Clinical trial NCT02964611: Social Cognition and Personality Changes in Alzheimer's & Parkinson's Disease & Frontotemporal Lobar Degeneration
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Parkinson's Disease
Frontotemporal Lobar Degeneration
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Alzheimer's disease, Parkinson's disease or Frontotemporal Lobar Degeneration

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.

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 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.

Primary outcomes:
measure: Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Personality via the Behaviour Inhibition/Approach Scale (BIS/BAS) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Personality via the Big Five Inventory (BFI) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Social cognition via Interpersonal Reactivity Index (IRI) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Social cognition via Revised Self-Monitoring Scale (RSMS) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Social cognition via Social Behaviour Observer Checklist and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Neuropsychiatric Inventory (NPI) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Clinical Dementia Rating Scale (CDR) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Functional Activities Questionnaire (FAQ) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Behavioural Tests composite score and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Emotion Evaluation Task (EET) portion of The Awareness of Social Inference Test and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Geriatric Depression Scale (GDS) and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
measure: Neuroimaging and differences between AD, PD, and FTLD
timeFrame: one time visit, through study completion of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Toronto Western Hospital, UHN; Tanz CRND
name: Maria C Tartaglia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: