BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers

Last updated: December 13, 2024
Sponsor: Butler Hospital
Overall Status: Active - Enrolling

Phase

N/A

Condition

Memory Loss

Dementia

Mental Disability

Treatment

Flutemetamol F18 Injection

[18F]-MK-6240 Injection

[18F]-RO6958948 Injection

Clinical Study ID

NCT05457998
1745146
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This research study aims to examine biomarkers of Alzheimer's disease as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Memory and Aging Program at Butler Hospital. The study will enroll up to 200 cognitively healthy subjects aged 50 to 80 years with ongoing recruitment and enrollment for 2 years, and subject participation lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure. Two PET imaging sub-studies will also be optional.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals between the ages of 50 and 80 years old (inclusive)

  • Score of 16 or above on the MoCA telephone

  • Score of 27 or greater on the MMSE for individuals aged 50 to 64 years old or ascore of 26 or greater for individuals aged 65 to 80 years old

  • Participants in the 50-60 age range will additionally need to meet at least one ofthe following: (1) First degree family history of dementia with onset before age 75; (2) APOE e4 allele carrier; or (3) Prior elevated result on amyloid PET or amyloidCSF testing

  • Conversationally fluent in English to the extent that an interpreter is notnecessary for comprehension of the study information, procedures, and cognitivetests.

  • If participants elect to participate in the optional disclosure procedure, they willbe required to have an appropriate study partner who agrees to participate in thestudy and who is intellectually, visually, and auditory capable, andconversationally fluent in English to the extent that an interpreter is notnecessary.

  • Adequate visual and auditory acuity to allow neuropsychological testing.

  • Participants must be willing and able to provide written informed consent.

Exclusion

Exclusion Criteria:

  • Diagnosis of mild cognitive impairment or dementia

  • History of significant brain injury or other known neurologic disease or insult,resulting in lasting cognitive sequelae that would confound the assessment andstaging of potential neurodegenerative disease (e.g., Huntington's disease,Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressivesupranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerativedementias, encephalitis or other brain infection, epilepsy or stroke with lastingimpairment to cognitive function).

  • Current serious or unstable systemic illness or organ failure that, in the PI'sjudgement, would make it difficult to participate in the study (e.g., such asterminal cancer, cardiovascular, hepatic, renal, gastroenterological, respiratory,endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease orother conditions ). History of cancer is acceptable with at least one year inremission with a good prognosis.

  • Individuals with clinically significant depression, bipolar disorder, anxiety, orsuicidal ideations within the past year as defined by the most current version ofthe Diagnostic and Statistical Manual of Mental Disorders (DSM).

  • A history of schizophrenia as defined by the most current version of the DSM.

  • History within the past year of chronic alcohol or drug abuse/dependence as definedby the most current version of the DSM.

  • Marijuana use is acceptable, but frequent users will be asked to abstain from usewithin 24 hours of any assessments.

  • Refusing or unable to complete any study procedures.

  • Currently enrolled in another study which involves clinical drug trial or othermedical intervention.

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Flutemetamol F18 Injection
Phase:
Study Start date:
June 14, 2023
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island 02906
    United States

    Site Not Available

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