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 range

18 Years – 80 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 80 Years

Sex

ALL

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