Clinical Trial: Cognitive Change in Behavioral Variant Frontotemporal Dementia (FTD)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: A Study to Model Rates of Change on Neuropsychological Test Measures in Subjects Diagnosed With Behavioral Variant Frontotemporal Dementia and Healthy Subjects

Brief Summary: The objectives of the study are to; (1) estimate the change in disease -related cognitive decline over 1 year on a battery of cognitive tests administered to participants with early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic variant; (2) identify the cognitive test or brief battery of cognitive tests which are the most sensitive to detect bvFTD progression; (3) determine the optimal schedule of administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship between cognitive tests and measures of behavior, function, caregiver's burden, quality of life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.

Detailed Summary:
Sponsor: Biogen

Current Primary Outcome:

  • Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall [ Time Frame: Up to 12 Months ]
    ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.
  • Annualized rate of change in Detection Test [ Time Frame: Up to 12 Months ]
    A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
  • Annualized rate of change in Identification Test [ Time Frame: Up to 12 Months ]
    A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
  • Annualized rate of change in One Back Test [ Time Frame: Up to 12 Months ]
    A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
  • Annualized rate of change in Groton Maze Learning Test [ Time Frame: Up to 12 Months ]
  • Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall [ Time Frame: Up to 12 Months ]
    ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.
  • Annualized rate of change in Detection Test [ Time Frame: Up to 12 Months ]
    A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
  • Annualized rate of change in Identification Test [ Time Frame: Up to 12 Months ]
    A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
  • Annualized rate of change in One Back Test [ Time Frame: Up to 12 Months ]
    A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
  • Annualized rate of change in Groton Maze Learning Test [ Time Frame: Up to 12 Months ]