RECRUITING

BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers

Talk to us

Conditions

Alzheimer DiseaseMild Cognitive ImpairmentDementiaEarly diagnosisBiomarkerPETMRIβ-amyloidtauCognitive test

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers

Quick Facts

Study Start:2023-06-14
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05457998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals between the ages of 50 and 80 years old (inclusive)
  2. * Score of 16 or above on the MoCA telephone
  3. * Score of 27 or greater on the MMSE for individuals aged 50 to 64 years old or a score of 26 or greater for individuals aged 65 to 80 years old
  4. * Participants in the 50-60 age range will additionally need to meet at least one of the 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 amyloid CSF testing
  5. * Conversationally fluent in English to the extent that an interpreter is not necessary for comprehension of the study information, procedures, and cognitive tests.
  6. * If participants elect to participate in the optional disclosure procedure, they will be required to have an appropriate study partner who agrees to participate in the study and who is intellectually, visually, and auditory capable, and conversationally fluent in English to the extent that an interpreter is not necessary.
  7. * Adequate visual and auditory acuity to allow neuropsychological testing.
  8. * Participants must be willing and able to provide written informed consent.
  1. * Diagnosis of mild cognitive impairment or dementia
  2. * History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease (e.g., Huntington's disease, Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerative dementias, encephalitis or other brain infection, epilepsy or stroke with lasting impairment to cognitive function).
  3. * Current serious or unstable systemic illness or organ failure that, in the PI's judgement, would make it difficult to participate in the study (e.g., such as terminal cancer, cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions ). History of cancer is acceptable with at least one year in remission with a good prognosis.
  4. * Individuals with clinically significant depression, bipolar disorder, anxiety, or suicidal ideations within the past year as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
  5. * A history of schizophrenia as defined by the most current version of the DSM.
  6. * History within the past year of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM.
  7. * Marijuana use is acceptable, but frequent users will be asked to abstain from use within 24 hours of any assessments.
  8. * Refusing or unable to complete any study procedures.
  9. * Currently enrolled in another study which involves clinical drug trial or other medical intervention.

Contacts and Locations

Study Contact

Tara Tang, BA
CONTACT
401-455-6402
memory@butler.org
Philip Caffery, PhD
CONTACT
401-455-6200
pcaffery@butler.org

Principal Investigator

Edward Huey, MD
PRINCIPAL_INVESTIGATOR
Butler Hospital Memory and Aging Program

Study Locations (Sites)

Butler Hospital Memory and Aging Program
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: Butler Hospital

  • Edward Huey, MD, PRINCIPAL_INVESTIGATOR, Butler Hospital Memory and Aging Program

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-06-14
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Early diagnosis
  • Biomarker
  • PET
  • MRI
  • β-amyloid
  • tau
  • Cognitive test

Additional Relevant MeSH Terms

  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Dementia