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

NCT01147679 | Unknown

• 3 other identifiers: 1R01AG034499UCLA IRB#10-001097R01AG034499
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  within three months of study enrollment

Study Arms (3)

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Violation of any of the criteria above.
• 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
• Violation of any of the criteria above.
• 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.
• Violation of any of the criteria above.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCLA Department of Neurology

Los Angeles, California, 90095, United States

RECRUITING

Related Links

• The website of the Association for Frontotemporal Degeneration

MeSH Terms

Conditions

Frontotemporal Dementia; Alzheimer Disease; Social Behavior; Behavior; Dementia

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies

Study Officials

• Mario F Mendez, MD, PhD

  University of California, Los Angeles; Veteran's Health Administration, West Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Shapira, RN, PhD

CONTACT

3107942550; jshapira@mednet.ucla.edu

Michelle Mather, BA

CONTACT

3107946038; mmather@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Psychiatry

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: July 1, 2014
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

US (1)