Alzheimer's DiseaseNCT02964611
Social Cognition and Personality Changes in Alzheimer's & Parkinson's Disease & Frontotemporal Lobar Degeneration
An observational study of Alzheimer's Disease and Parkinson's Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Parkinson's Disease, Frontotemporal Lobar Degeneration
- What is being tested?
- Observational Study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to 16 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosis of Alzheimer's disease, Parkinson's disease or Frontotemporal Lobar Degeneration
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
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
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.
Read the 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.
- Being tested
- Observational Study
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyBehavioural
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease | Observational Study Receives: Behavioral: Observational Study | |
| Parkinson's disease | Observational Study Receives: Behavioral: Observational Study | |
| Frontotemporal Lobar Degeneration | Observational Study Receives: Behavioral: Observational Study | |
| Healthy Controls | Observational Study Receives: Behavioral: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD
Assesses interpersonal aspects of personality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: one time visit, through study completion of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJan 2013
- Primary completion16 Aug 2016
- Study completion16 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
- Investigators
- Maria C Tartaglia, M.D., Principal investigator, Toronto Western Hospital, UHN; Tanz CRND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964611
- Sponsor's protocol ID
- 12-0451-BE
- Status last verified
- Apr 2019
- First submitted
- 23 Sep 2016
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02964611
- Acronym / sponsor ID
- 12-0451-BE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 16 Aug 2016 (actual)
- Study completion
- 16 Aug 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | – | Behavioral: Observational StudyObservational Study |
| Parkinson's disease | – | Behavioral: Observational StudyObservational Study |
| Frontotemporal Lobar Degeneration | – | Behavioral: Observational StudyObservational Study |
| Healthy Controls | – | Behavioral: Observational StudyObservational Study |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Alzheimer's disease, Parkinson's disease or Frontotemporal Lobar Degeneration
Key inclusion criteria (5 listed)
- ability to speak and understand the English language (as questionnaires and tests are only available in English)
- primary caregiver for a given patient
- ability to speak and understand the English language (as questionnaires and tests are only available in English)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyThis is an observational study. | Behavioural | Alzheimer's disease, Frontotemporal Lobar Degeneration, Healthy Controls, Parkinson's disease |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria C Tartaglia, M.D. principal investigator
Toronto Western Hospital, UHN; Tanz CRND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Parkinson's Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personality via the Interpersonal Adjectives Scales and differences between AD, PD, and FTLD (time frame: one time visit, through study completion of 3 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.