A Study to Model Rates of Change on Neuropsychological Test Measures in Subjects Diagnosed With Behavioral Variant Frontotemporal Dementia and Healthy Subjects

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

Sponsors

Lead sponsor: Biogen

Source Biogen
Brief 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.

Overall Status Completed
Start Date January 29, 2018
Completion Date September 23, 2019
Primary Completion Date September 23, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall Up to 12 Months
Annualized rate of change in Detection Test Up to 12 Months
Annualized rate of change in Identification Test Up to 12 Months
Annualized rate of change in One Back Test Up to 12 Months
Annualized rate of change in Groton Maze Learning Test Up to 12 Months
Annualized rate of change in ISLT - Delayed Recall Up to 12 Months
Annualized rate of change in Social Emotional Cognition Test (SECT) Up to 12 Months
Annualized rate of change in Letter Fluency Up to 12 Months
Annualized rate of change in Category Fluency Up to 12 Months
Annualized rate of change in Digit Symbol Coding (DSC) Up to 12 Months
Annualized rate of change in Letter Number Sequencing (LNS) Up to 12 Months
Annualized rate of change in Mini Mental State Examination (MMSE) Up to 12 Months
Change from Day 1 in International Shopping List Test (ISLT) - Immediate Recall Up to 12 Months
Change from Day 1 in Detection Test Up to 12 Months
Change from Day 1 in Identification Test Up to 12 Months
Change from Day 1 in One Back Test Up to 12 Months
Change from Day 1 in Groton Maze Learning Test Up to 12 Months
Change from Day 1 in ISLT- Delayed Recall Up to 12 Months
Change from Day 1 in SECT Up to 12 Months
Change from Day 1 in Letter Fluency Up to 12 Months
Change from Day 1 in Category Fluency Up to 12 Months
Change from Day 1 in DSC Up to 12 Months
Change from Day 1 in LNS Up to 12 Months
Change from Day 1 in MMSE Up to 12 months
Actual values from Day 1 in Neurophsychic Inventory (NPI) Up to 12 Months
Change from Day 1 in NPI Up to 12 Months
Actual values from Day 1 in Neurophsychic Inventory Questionnaire (NPI-Q) Up to 12 Months
Change from Day 1 in NPI-Q Up to 12 Months
Actual values from Day 1 in Revised Self-Monitoring Scale Up to 12 Months
Change from Day 1 in Revised Self-Monitoring Scale Up to 12 Months
Actual values from Day 1 in Apathy Inventory Up to 12 Months
Change from Day 1 in Apathy Inventory Up to 12 Months
Actual values from Day 1 in Family Accommodation Scale for Obsessive Compulsive Disorder - Self Rated (FAS-SR) Up to 12 Months
Change from Day 1 in FAS-SR Up to 12 Months
Actual values from Day 1 in Behavior Rating Scale Up to 12 Months
Change from Day 1 in Behavior Rating Scale Up to 12 Months
Actual values from Day 1 in Functional Activities Questionnaire (FAQ) Up to 12 Months
Change from Day 1 in FAQ Up to 12 Months
Actual values from Day 1 in Clinical Global Impression of Change (CGIC) Up to 12 Months
Change from Day 1 in CGIC Up to 12 Months
Actual values from Day 1 in Clinical Dementia Rating-Frontotemporal Lobar Degeneration (CDR-FTLD) Up to 12 Months
Change from Day 1 in CDR-FTLD Up to 12 Months
Actual values from Day 1 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Up to 12 Months
Change from Day 1 in UPDRS Part III Up to 12 Months
Actual values from Day 1 of caregiver's Quality of Life (QOL) in Zarit Caregiver Burden Interview Up to 12 Months
Change from Day 1 of caregiver's QOL in Zarit Caregiver Burden Interview Up to 12 Months
Actual values from Day 1 of QOL in Geriatric Depression Scale- Short Form (GDS-SF) Up to 12 Months
Change from Day 1 of QOL in GDS-SF Up to 12 Months
Actual values from Day 1 of caregiver's QOL in Caregiver Assessment Measure Up to 12 Months
Change from Day 1 of caregiver's QOL in Caregiver Assessment Measure Up to 12 Months
Actual values from Day 1 of QOL in Quality of Life in Neurological Disorders (NeuroQOL) Up to 12 Months
Change from Day 1 of QOL in Quality of Life in NeuroQOL Up to 12 Months
Actual values from Day 1 of QOL in EuroOol 5 Dimensions Questionnaire (EQ-5D) Up to 12 Months
Change from Day 1 of QOL in EQ-5D Up to 12 Months
Actual values from Day 1 of QOL in Affect and Activity Indicators of QOL (AAIQOL) Up to 12 Months
Change from Day 1 of QOL in AAIQOL Up to 12 Months
Actual values from Day 1 for exploratory biomarkers Baseline, Month 12
Change from Day 1 for exploratory blood biomarkers Baseline, Month 12
bvFTD genetic mutations identification in whole blood samples Baseline, Month 12
Potential identification of genetic biomarkers associated with bvFTD from DNA/RNA in whole blood samples Baseline, Month 12
Actual values at Day 1 in Clinical Global Impression of Severity (CGIS) Day 1
Enrollment 47
Condition
Intervention

Intervention type: Other

Intervention name: Assessments

Description: Cognitive, Behavioral and Functional as described in the Outcome Measures

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Medical Director Study Director Biogen
Location
facility
Research Site | Birmingham, Alabama, 35233, United States
Research Site | Los Angeles, California, 90095, United States
Research Site | Boca Raton, Florida, 33431, United States
Research Site | Boca Raton, Florida, 33486, United States
Research Site | Atlanta, Georgia, 30322, United States
Research Site | Elk Grove Village, Illinois, 60007, United States
Research Site | Baltimore, Maryland, 21218, United States
Research Site | Rochester, Minnesota, 55905, United States
Research Site | Columbus, Ohio, 43220, United States
Research Site | Philadelphia, Pennsylvania, 19104, United States
Research Site | Knoxville, Tennessee, 37909, United States
Research Site | Seattle, Washington, 98104, United States
Location Countries

United States

Verification Date

November 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: bvFTD

Description: Participants with behavioral variant frontotemporal dementia (bvFTD) (n=37)

Arm group label: Healthy

Description: Healthy Participants (n=10)

Acronym FORWARD
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov