Information about how early cognitive tests can detect changes in the progression of bvFTD is limited; this information is also unreliable because the assessments are typically performed yearly, mainly using tests that are not meant to diagnose the disease. The purpose of this observational study is to identify measures of cognition that can predict progression of bvFTD over 12 months or less, estimate the size of this change, and estimate the relationship between changes in cognition and measures of behavior, function, quality of life, and caregiver burden. Identification of cognitive measures that mirror important changes associated with disease progression, that are brief, sensitive to change and predictive of bvFTD progression over a short time would greatly benefit the development of drugs to treat bvFTD.
Your participation in the study is voluntary.
Duration: Approximately 1 year
6 clinic visits in UCLA
8 home visits (or other quiet and suitable setting)
Blood and Urine tests
Short thinking tests or “brain tasks”
Healthy volunteers will be compensated with
per clinic visit only (home visits not included). Parking validation will be provided on clinic visits.
$40 gift card
To be eligible to participate in this study, Healthy Volunteer candidates must meet the following eligibility criteria at Screening or at the timepoint specified in the individual eligibility criterion listed:
Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
Aged 18 to 80 years old, inclusive, at the time of informed consent.
Must speak, and understand oral and written English.
Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening, or at the timepoint specified in the individual criterion listed:
Inability to comply with study requirements.
Unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
Alcohol or substance use:
History of alcohol or substance abuse (as determined by the Investigator).
Unwillingness to refrain from recreational drugs use and frequent alcohol use that would interfere with study conduct in the Investigator’s opinion.
Unwillingness to refrain from illicit drugs use during the study.
Positive alcohol test, performed at Screening at the Investigator’s discretion.
Positive urine drug screen, performed at Screening.
Current use of psychoactive medication that will interfere with accurate assessment of cognition (as assessed by the Investigator), including long acting benzodiazepines (short-acting benzodiazepines are allowed if taken more than 12 hours before cognitive test), non-selective serotonin reuptake inhibitor antidepressants (SSRI antidepressants and trazodone are allowed), lithium, neuroleptics, narcotics (codeine is allowed if taken 24 hours before cognitive testing), anticonvulsants outside of therapeutic ranges, and antihistamines if taken more than 3 times per week (if not, antihistamines are allowed if taken 24 hours before cognitive testing).
Current enrollment or intention to enroll within a year, in any drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior to Screening.
Other protocol defined Inclusion/Exclusion criteria may apply
Study Sponsor: Biogen
If interested, please contact the Study Coordinator: Diana Chavez via email at
DianaChavez@mednet.ucla.edu or call at (310)478-3711 x.48176.