Study of Social Behavior and Emotion in Frontotemporal Dementia, Alzheimer's Disease and Controls
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|ClinicalTrials.gov Identifier: NCT01147679|
Recruitment Status : Unknown
Verified October 2011 by Mario F. Mendez, University of California, Los Angeles.
Recruitment status was: Recruiting
First Posted : June 22, 2010
Last Update Posted : October 28, 2011
|Condition or disease|
|Frontotemporal Dementia Frontotemporal Degeneration Alzheimer's Disease Social Behavior|
|Study Type :||Observational|
|Estimated Enrollment :||99 participants|
|Observational Model:||Case Control|
|Official Title:||Study of Social Behavior and Emotion in Frontotemporal Dementia, Alzheimer's Disease and Controls|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||July 2014|
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.
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.
33 health individuals without clinically significant cognitive impairments will be enrolled in this study.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147679
|Contact: Jill Shapira, RN, PhDfirstname.lastname@example.org|
|Contact: Michelle Mather, BAemail@example.com|
|United States, California|
|UCLA Department of Neurology||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Michelle Mather, BA 310-794-6038 firstname.lastname@example.org|
|Contact: Jill Shapira, RN, PhD 3107942550 email@example.com|
|Principal Investigator: Mario F Mendez, MD, PhD|
|Sub-Investigator: David Shapiro, PhD|
|Sub-Investigator: Jill Shapira, RN, PhD|
|Sub-Investigator: Po-Haong Lu, PsyD|
|Sub-Investigator: John Heritage, PhD|
|Sub-Investigator: Li-Jung Liang, PhD|
|Sub-Investigator: Natalie K Wolcott, PhD|
|Sub-Investigator: Aditi Joshi, PhD|
|Sub-Investigator: Julia Hsiao, DO|
|Sub-Investigator: Collins Liu, MD|
|Principal Investigator:||Mario F Mendez, MD, PhD||University of California, Los Angeles; Veteran's Health Administration, West Los Angeles|