Cognitive, Behavioral, and Functional Change in Behaviora... | NCT03088956

Status Module

Description Module

Label	Type	Description	Intervention Names
bvFTD		Participants with behavioral variant frontotemporal dementia (bvFTD) (n=37)	Other: Assessments
Healthy		Healthy Participants (n=10)	Other: Assessments

Name	Type	Description	Arm Group Labels	Other Names
Assessments	Other	Cognitive, Behavioral and Functional as described in the Outcome Measures	Healthy bvFTD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall	ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.	Up to 12 Months
Annualized rate of change in Detection Test	A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.	Up to 12 Months
Annualized rate of change in Identification Test	A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.	Up to 12 Months
Annualized rate of change in One Back Test	A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.	Up to 12 Months
Annualized rate of change in Groton Maze Learning Test	Modified version (10 x 10, "snake maze" version): this is a test that uses a maze learning paradigm to measure executive function and spatial learning. The score for this test is based on the total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores indicate better performance.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35233	United States
Research Site

ID	Term
D057174	Frontotemporal Lobar Degeneration
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D057177	TDP-43 Proteinopathies
D019636	Neurodegenerative Diseases
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders