CompletedNot Applicable

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

United States47 participantsStarted 2018-01-19

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 condit…

What they're measuring

Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall

Timeframe: Up to 12 Months

Annualized rate of change in Detection Test

Timeframe: Up to 12 Months

Annualized rate of change in Identification Test

Timeframe: Up to 12 Months

Annualized rate of change in One Back Test

Timeframe: Up to 12 Months

Annualized rate of change in Groton Maze Learning Test

Timeframe: Up to 12 Months

Annualized rate of change in ISLT - Delayed Recall

Timeframe: Up to 12 Months

Annualized rate of change in Social Emotional Cognition Test (SECT)

Timeframe: Up to 12 Months

Annualized rate of change in Letter Fluency

Timeframe: Up to 12 Months

Trial details

NCT IDNCT03088956

SponsorBiogen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-09-23

View on ClinicalTrials.gov More Frontotemporal Dementia trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall

Timeframe: Up to 12 Months

Annualized rate of change in Detection Test

Timeframe: Up to 12 Months

Annualized rate of change in Identification Test

Timeframe: Up to 12 Months

Annualized rate of change in One Back Test

Timeframe: Up to 12 Months

Annualized rate of change in Groton Maze Learning Test

Timeframe: Up to 12 Months

Annualized rate of change in ISLT - Delayed Recall

Timeframe: Up to 12 Months

Annualized rate of change in Social Emotional Cognition Test (SECT)

Timeframe: Up to 12 Months

Annualized rate of change in Letter Fluency

Timeframe: Up to 12 Months