Frontotemporal DementiaNCT01147679
Study of Social Behavior and Emotion in Frontotemporal Dementia, Alzheimer's Disease and Controls
An observational study of Frontotemporal Dementia and Frontotemporal Degeneration, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is designed to document the loss of sociomoral emotions (like empathy, guilt, and embarrassment) in patients with behavioral variant frontotemporal dementia. The loss of these emotions, which function as the motivators for social behavior, will manifest in specific interpersonal behaviors. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Dementia, Frontotemporal Degeneration, Alzheimer's Disease
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2014
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients evaluated by Dr. Mario Mendez at the UCLA Frontotemporal Dementia Clinic
Who may be able to join
- The core diagnostic features of bvFTD or NINCDS-ADRDA criteria for clinically probable AD
- Mild-moderate cognitive and functional severity defined as an MMSE >/=10 and a CDR </=2.0
- Able to understand and complete procedures and to take part in the tests by hearing and understanding instructions and by seeing the stimuli to be responded to
- Willingness and ability to provide informed consent; Informed consents from caregiver and patient
- English speaking, having acquired English prior to age 13 and using it as primary language
- Minimally impaired language (language and semantics tests cut-off scores)
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- Medically stable (defined as absence of medical illness that would interfere with the subject's ability to understand and participate in study procedures)
- Absence of a neurological or psychiatric illness other than bvFTD or clinically probable ADB
- Absence of cortical infarction, other cortical lesion, or significant subcortical lesion on MRI of brain
- Absence of potentially confounding medications, particularly those with effects on the peripheral nervous system, cardiovascular agents, and β-blockers
- Presence of a caregiver who can facilitate participation in this project. (see below) Where there is more than one caregiver, every effort is made to designate the closest relative as the main caregiver.
- Personally visit and interact with the subject at least one time each week for one hour.
- Accompany the subject to each visit.
- Provide opinions about the subject's thinking (i.e., memory, language, problem-solving ability), daily activities (i.e., dressing, hygiene, mobility, household chores, and hobbies), and behavior (i.e., mood, sleep patterns, appetite, participation in social interactions).
- Share personal information including feelings of distress about the subject's behavior or feelings of burden by caregiving responsibilities.
- Read, understand and speak English fluently in order to ensure comprehension of informed consent form and informant-based assessments of the subject.
- Provide full written informed consent on his/her own behalf prior to the performance of any protocol-specific procedure.
- In the opinion of the investigator, the study partner will be compliant with the protocol and have a high probability of completing the study
- Denies neurological or psychiatric illness.
- Not currently a caregiver for a dementia patient (for at least one year).
- Does not take potentially confounding medications, including most of those with effects on the central nervous system and peripheral nervous system, cardiovascular agents, and β-blockers. The use of these medications will be assessed during a telephone screening.
Who cannot join
- Violation of any of the criteria above.
- Violation of any of the criteria above.
- Violation of any of the criteria above.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UCLA Department of Neurology
Los Angeles, California, 90095
Michelle Mather, BA, 310-794-6038, mmather@mednet.ucla.edu
Jill Shapira, RN, PhD, 3107942550, jshapira@mednet.ucla.edu
About this study
This study is designed to document the loss of sociomoral emotions (like empathy, guilt, and embarrassment) in patients with behavioral variant frontotemporal dementia. The loss of these emotions, which function as the motivators for social behavior, will manifest in specific interpersonal behaviors. These behaviors will correlate with regional changes in regional changes in medial frontal and anterior temporal lobes. These social and emotional changes will be compared with a young-onset Alzheimer's disease comparison group.
Read the detailed description
Frontotemporal dementia (FTD) is a devastating disorder and one the most common neurodegenerative diseases in middle age. The most prominent early manifestations of bvFTD ("behavior variant" FTD) are not the memory and other cognitive deficits typical of Alzheimer's disease (AD) but, rather, disturbance in social or interpersonal behavior. A basic manifestation of this disorder is a disturbance in the emotions and motives that drive social and moral behavior. In fact, bvFTD is an incredible window to the neuroscience of social behavior. This study will help clarify the neurobiological substrates of sociomoral emotions and their associated clinical features. The findings of this proposal can have major implications for understanding the interaction between brain and social behavior and for designing future research on the basic mechanisms of social neuroscience. This research aims to document the loss of sociomoral emotions (SME) compared to primary emotions in patients with bvFTD vs. patients with AD and normal controls. We need to show that these findings are specific to bvFTD and not present in Alzheimer's disease or normal controls. The project consists of three integrated parts: 1) behavioral measures that include observations in naturalistic settings, behavioral experiments, and behavioral scales; 2) psychophysiological reactivity (i.e., measures of heart rate, blood pressure changes, galvanic skin response, facial electromyography, and facial temperature) to social and emotional stimuli; and 3) brain localization of changes in sociomoral emotions with magnetic resonance imaging technology.
- Conditions
- Frontotemporal Dementia, Frontotemporal Degeneration, Alzheimer's Disease, Social Behavior
- Keywords
- Frontotemporal dementia, Alzheimer's disease, Young-Onset, Frontotemporal degeneration, control, social, behavior, observation, emotion, morality, dementia, brain, relationships, caregiver, MRI, neurology
- Medical subject headings
- Frontotemporal Dementia, Alzheimer Disease, Social Behavior, Behavior, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| bvFTD | This group will include 33 patients who have been diagnosed with behavioral variant frontotemporal dementia by Dr. Mario Mendez. Patients diagnosed elsewhere must have a secondary evaluation at the UCLA FTD Clinic to confirm their diagnosis before study enrollment. | |
| Alzheimer's disease | This group will include 33 patients who have been diagnosed with clinically probable Alzheimer's disease by Dr. Mario Mendez. Patients diagnosed elsewhere must have a secondary evaluation at the UCLA FTD Clinic to confirm their diagnosis before study enrollment. | |
| Controls | 33 health individuals without clinically significant cognitive impairments will be enrolled in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychophysiological Reactivity
We will evaluate autonomic (sympathetic and parasympathetic) nervous system reactivity to sociomoral vs. non-social stimuli using measures of heart rate (and heart rate variability), blood pressure (and baroreflex sensitivity), finger pulse volume, and skin conductance changes. Investigators present social and non-social pictures, videos, and written scenarios to all three groups while recording these psychophysiologic measures.
Measured: within three months of study enrollment
Behavioral Reports and Observations
This proposal will use methods of ethnography to classify the social behavior of bvFTD and AD patients and their caregivers in their homes and during research visits. Four social behavioral experiments or vignettes will be used to cross-validate the results of augmented participant observation. Behavioral scales will record differences between caregiver and patient assessments of behavior and further validate the results of the participant observation.
Measured: within three months of study enrollment
MRI Brain-Mapping
An MRI scan evaluated with state-of-the-art techniques will yield three dimensional maps of localized structural changes that reflect the regions involved in mediating social, moral, and emotional behaviors.
Measured: within three months of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mario F. Mendez, University of California, Los Angeles
- Investigators
- Mario F Mendez, MD, PhD, Principal investigator, University of California, Los Angeles; Veteran's Health Administration, West Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147679
- Sponsor's protocol ID
- 1R01AG034499
- Other IDs
- UCLA IRB#10-001097, R01AG034499
- Status last verified
- Oct 2011
- First submitted
- 18 Jun 2010
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Social Behavior and Emotion in Frontotemporal Dementia, Alzheimer's Disease and Controls
- ClinicalTrials.gov ID
- NCT01147679
- Acronym / sponsor ID
- 1R01AG034499
- Conditions
- Frontotemporal Dementia, Frontotemporal Degeneration, Alzheimer's Disease, Social Behavior
- Keywords
- Frontotemporal dementia, Alzheimer's disease, Young-Onset, Frontotemporal degeneration, control, social, behavior, observation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 22 Jun 2010 (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.
This study is designed to document the loss of sociomoral emotions (like empathy, guilt, and embarrassment) in patients with behavioral variant frontotemporal dementia. The loss of these emotions, which function as the motivators for social behavior, will manifest in specific interpersonal behaviors. These behaviors will correlate with regional changes in regional changes in medial frontal and anterior temporal lobes. These social and emotional changes will be compared with a young-onset Alzheimer's disease comparison group.
Detailed description
Frontotemporal dementia (FTD) is a devastating disorder and one the most common neurodegenerative diseases in middle age. The most prominent early manifestations of bvFTD ("behavior variant" FTD) are not the memory and other cognitive deficits typical of Alzheimer's disease (AD) but, rather, disturbance in social or interpersonal behavior. A basic manifestation of this disorder is a disturbance in the emotions and motives that drive social and moral behavior. In fact, bvFTD is an incredible window to the neuroscience of social behavior. This study will help clarify the neurobiological substrates of sociomoral emotions and their associated clinical features. The findings of this proposal can have major implications for understanding the interaction between brain and social behavior and for designing future research on the basic mechanisms of social neuroscience. This research aims to document the loss of sociomoral emotions (SME) compared to primary emotions in patients with bvFTD vs. patients with AD and normal controls. We need to show that these findings are specific to bvFTD and not present in Alzheimer's disease or normal controls. The project consists of three integrated parts: 1) behavioral measures that include observations in naturalistic settings, behavioral experiments, and behavioral scales; 2) psychophysiological reactivity (i.e., measures of heart rate, blood pressure changes, galvanic skin response, facial electromyography, and facial temperature) to social and emotional stimuli; and 3) brain localization of changes in sociomoral emotions with magnetic resonance imaging technology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bvFTD | – | –This group will include 33 patients who have been diagnosed with behavioral variant frontotemporal dementia by Dr. Mario Mendez. Patients diagnosed elsewhere must have a secondary evaluation at the UCLA FTD Clinic to confirm their diagnosis before study enrollment. |
| Alzheimer's disease | – | –This group will include 33 patients who have been diagnosed with clinically probable Alzheimer's disease by Dr. Mario Mendez. Patients diagnosed elsewhere must have a secondary evaluation at the UCLA FTD Clinic to confirm their diagnosis before study enrollment. |
| Controls | – | –33 health individuals without clinically significant cognitive impairments will be enrolled in this study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients evaluated by Dr. Mario Mendez at the UCLA Frontotemporal Dementia Clinic
Key inclusion criteria (21 listed)
- The core diagnostic features of bvFTD or NINCDS-ADRDA criteria for clinically probable AD
- Mild-moderate cognitive and functional severity defined as an MMSE >/=10 and a CDR </=2.0
- Able to understand and complete procedures and to take part in the tests by hearing and understanding instructions and by seeing the stimuli to be responded to
- Willingness and ability to provide informed consent; Informed consents from caregiver and patient
- English speaking, having acquired English prior to age 13 and using it as primary language
Key exclusion criteria (3 listed)
- Violation of any of the criteria above.
- Violation of any of the criteria above.
- Violation of any of the criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychophysiological Reactivity
Time frame: within three months of study enrollment
We will evaluate autonomic (sympathetic and parasympathetic) nervous system reactivity to sociomoral vs. non-social stimuli using measures of heart rate (and heart rate variability), blood pressure (and baroreflex sensitivity), finger pulse volume, and skin conductance changes. Investigators present social and non-social pictures, videos, and written scenarios to all three groups while recording these psychophysiologic measures.
Behavioral Reports and Observations
Time frame: within three months of study enrollment
This proposal will use methods of ethnography to classify the social behavior of bvFTD and AD patients and their caregivers in their homes and during research visits. Four social behavioral experiments or vignettes will be used to cross-validate the results of augmented participant observation. Behavioral scales will record differences between caregiver and patient assessments of behavior and further validate the results of the participant observation.
MRI Brain-Mapping
Time frame: within three months of study enrollment
An MRI scan evaluated with state-of-the-art techniques will yield three dimensional maps of localized structural changes that reflect the regions involved in mediating social, moral, and emotional behaviors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- The website of the Association for Frontotemporal DegenerationLink provided by the sponsor.
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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.
Mario F Mendez, MD, PhD principal investigator
University of California, Los Angeles; Veteran's Health Administration, West Los Angeles
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 Frontotemporal Dementia and Frontotemporal Degeneration, run by University of California, Los Angeles at 1 site in United States.
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 21 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2011. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Shapira, RN, PhD (3107942550, jshapira@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysiological Reactivity (time frame: within three months of study enrollment). The study lists 3 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 28 Oct 2011.