Study of Social Behavior and Emotion in Frontotemporal Dementia, Alzheimer's Disease and Controls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mario F. Mendez, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01147679
First received: June 18, 2010
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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.


Condition
Frontotemporal Dementia
Frontotemporal Degeneration
Alzheimer's Disease
Social Behavior

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Social Behavior and Emotion in Frontotemporal Dementia, Alzheimer's Disease and Controls

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Psychophysiological Reactivity [ Time Frame: within three months of study enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 99
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients evaluated by Dr. Mario Mendez at the UCLA Frontotemporal Dementia Clinic

Criteria

Inclusion Criteria (FTD or AD patients):

  • 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)
  • 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.

Exclusion Criteria (FTD or AD patients):

  • Violation of any of the criteria above.

Inclusion Criteria (Study Partners/Caregivers):

  • 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

Exclusion Criteria (Study Partners):

  • Violation of any of the criteria above.

Inclusion Criteria (Control Participants):

  • 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.

Exclusion Criteria (Control Participants):

  • Violation of any of the criteria above.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147679

Contacts
Contact: Jill Shapira, RN, PhD 3107942550 jshapira@mednet.ucla.edu
Contact: Michelle Mather, BA 3107946038 mmather@mednet.ucla.edu

Locations
United States, California
UCLA Department of Neurology Recruiting
Los Angeles, California, United States, 90095
Contact: Michelle Mather, BA    310-794-6038    mmather@mednet.ucla.edu   
Contact: Jill Shapira, RN, PhD    3107942550    jshapira@mednet.ucla.edu   
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         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Mario F Mendez, MD, PhD University of California, Los Angeles; Veteran's Health Administration, West Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Mario F. Mendez, Professor of Neurology and Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01147679     History of Changes
Other Study ID Numbers: 1R01AG034499, UCLA IRB#10-001097, R01AG034499
Study First Received: June 18, 2010
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Frontotemporal dementia
Alzheimer's disease
Young-Onset
Frontotemporal degeneration
control
social
behavior
observation
emotion
morality
dementia
brain
relationships
caregiver
MRI
neurology

Additional relevant MeSH terms:
Frontotemporal Dementia
Pick Disease of the Brain
Alzheimer Disease
Dementia
Aphasia, Primary Progressive
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014