Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT01147679

Conditions

Frontotemporal Dementia

Frontotemporal Degeneration

Alzheimer's Disease

Social Behavior

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT01147679

Start date

Jan, 2010

Status verified date

Oct, 2011

Completion date

Jul, 2014

Anticipated

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

99 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Psychophysiological Reactivity [ Time Frame: within three months of study enrollment ]
  • Behavioral Reports and Observations [ Time Frame: within three months of study enrollment ]
  • MRI Brain-Mapping [ Time Frame: within three months of study enrollment ]

Central Contacts and Locations

Central contacts

Locations

UCLA Department of Neurology

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Mario F Mendez, MD, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Oct 28, 2011

Last verified

Oct, 2011

Keywords

  • Frontotemporal dementia
  • Alzheimer's disease
  • Young-Onset
  • Frontotemporal degeneration
  • control
  • social
  • behavior
  • observation
  • emotion
  • morality
  • dementia
  • brain
  • relationships
  • caregiver
  • MRI
  • neurology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2011-10-28.