Cognitive Change in Behavioral Variant Frontotemporal Dementia (FTD)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003544
NCT ID: NCT03088956
Sponsor Protocol Number: 992FD001
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
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.
Exclusion Criteria
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bradley Boeve, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available