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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
- •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.
结局指标
主要结局
Social cognition via Social Norms Questionnaire and differences between AD, PD, and FTLD
时间窗: one time visit, through study completion of 3 years
Assesses the patient's understanding of culturally relevant social norms
Emotion Evaluation Task (EET) portion of The Awareness of Social Inference Test and differences between AD, PD, and FTLD
时间窗: 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.
Personality via the Behaviour Inhibition/Approach Scale (BIS/BAS) and differences between AD, PD, and FTLD
时间窗: 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
Social cognition via Revised Self-Monitoring Scale (RSMS) and differences between AD, PD, and FTLD
时间窗: 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
Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD
时间窗: one time visit, through study completion of 3 years
Assesses interpersonal aspects of personality
Personality via the Big Five Inventory (BFI) and differences between AD, PD, and FTLD
时间窗: 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 Interpersonal Reactivity Index (IRI) and differences between AD, PD, and FTLD
时间窗: 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
Geriatric Depression Scale (GDS) and differences between AD, PD, and FTLD
时间窗: one time visit, through study completion of 3 years
Assesses mood and depression in geriatric patients
Neuroimaging and differences between AD, PD, and FTLD
时间窗: one time visit, through study completion of 3 years
Functional connectivity of networks associated with social cognition and personality
Social cognition via Social Behaviour Observer Checklist and differences between AD, PD, and FTLD
时间窗: 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
时间窗: 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
Functional Activities Questionnaire (FAQ) and differences between AD, PD, and FTLD
时间窗: 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
时间窗: one time visit, through study completion of 3 years
Orientation, Digit span backward and forward, Naming, Modified trails, Benson figure copy, Cerad, Clock draw
Clinical Dementia Rating Scale (CDR) and differences between AD, PD, and FTLD
时间窗: 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
次要结局
未报告次要终点
研究者
Carmela Tartaglia
Principal Investigator
University Health Network, Toronto