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Summary

for people ages 18–80 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Frontotemporal Dementia Behavioral Variant Frontotemporal Dementia Longitudinal Caregiver Cognitive assessments Behavioral assessments Functional assessments Dementia Alzheimer Disease Aphasia, Primary Progressive Pick Disease of the Brain

Eligibility

For people ages 18–80

Key Inclusion Criteria for Participants with behavioral variant frontotemporal dementia(bvFTD):

  • Must speak and understand oral and written English.
  • Must have probable bvFTD.
  • Must have a global Clinical Dementia Rating (CDR) score of 0.5-1 and a Mini Mental State Examination (MMSE) score ≥20 to reflect early stages of disease.
  • Must have 1 informant/caregiver who, in the Investigator's judgment, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's behaviors as well as cognitive and functional abilities.
  • Must be ambulatory or able to walk with assistance and not be institutionalized.

Key Inclusion Criteria for Healthy Participants:

  • Must speak and understand oral and written English.
  • Must be in good general health determined by Investigator.

Key Exclusion Criteria for Participants with bvFTD:

  • Concomitant motor neuron disease with limb or bulbar weakness which, in the opinion of the Investigator, may affect performance over the course of the study. Participants with bvFTD with motor neuron disease are otherwise allowed to participate.
  • Known presence of a structural brain lesion that could reasonably explain symptoms.
  • Diagnosis of Alzheimer's disease and/or known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or neuropathological evidence for Alzheimer's disease as a cause of syndrome.
  • History of other acute or chronic neurological or psychiatric conditions that are unrelated and may confound a diagnosis of bvFTD and that, in the opinion of the Investigator, may affect cognition, behavior, or ability to complete the study.
  • History of severe alcohol or substance abuse.
  • History of disorders that could confound a diagnosis of bvFTD.
  • Use of allowed chronic medications at doses that have not been stable for at least 4 weeks prior to Screening.
  • Current use of psychoactive medication that will interfere with accurate assessment of cognition (as assessed by the Investigator)

Key Exclusion Criteria for Healthy Participants:

  • History of alcohol or substance abuse.
  • Current use of psychoactive medication that will interfere with accurate assessment of cognition (as assessed by the Investigator).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Research Site not yet accepting patients
    San Francisco, California, 94143, United States
  • Research Site accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
ID
NCT03088956
Study Type
Observational
Last Updated
November 21, 2017
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