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

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

NCT03088956•Biogen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

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

Locations (12)

Research Site

Birmingham, Alabama, United States

Research Site

Los Angeles, California, United States

Research Site

Boca Raton, Florida, United States

Research Site

Boca Raton, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Elk Grove Village, Illinois, United States

Research Site

Baltimore, Maryland, United States

Research Site

Rochester, Minnesota, United States

Research Site

Columbus, Ohio, United States

Research Site

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 19, 2018

Primary Completion Date

September 23, 2019

Completion Date

September 23, 2019

Last Updated

June 16, 2020

Enrollment

ACTUAL participants

Conditions

Frontotemporal DementiaBehavioral Variant Frontotemporal Dementia

Interventions

Assessments

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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