Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03088956
Eligibility 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.
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03088956
Study Brief:
Protocol Section:
NCT03088956