Cognitive, Behavioral, and Functional Change in Behavioral Variant Frontotemporal Dementia (bvFTD)



Status:Active, not recruiting
Conditions:Alzheimer Disease, Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:10/20/2018
Start Date:January 29, 2018
End Date:January 16, 2020

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

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.


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
We found this trial at
12
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Atlanta, Georgia
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Birmingham, Alabama
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Boca Raton, Florida
Phone: 561-297-4984
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Elk Grove Village, Illinois 60007
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Los Angeles, California
Phone: 310-478-3711
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Philadelphia, Pennsylvania
Phone: 215-662-3596
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Seattle, Washington 98105
Phone: 206-221-9038
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