Clinical trial NCT06121544: The Swedish BioFINDER - Preclinical AD Study
Official title: The Swedish BioFINDER - Preclinical AD Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Mild Dementia
Keywords: Preclinical Alzheimer, early diagnosis, biomarkers, plasma, CSF, PET
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-11-08
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cognitively unimpaired individuals (50-80 y) Step 1. Cognitively normal individuals will be screened using plasma p-tau217 (Eli Lilly-developed MSD method).

Step 2. CSF AD biomarkers will be done in a subpopulation including all plasma p-tau217 positive individuals and randomly selected individuals with normal p-tau217 (matching 9:1).

Step 3. Amyloid PET imaging.

450 individuals with positive AD biomarkers and 150 with normal AD biomarkers will be enrolled into longitudinal study.

FOLLOW-UP FOR 4 YEARS: Cognitive testing and blood draws will be conducted at baseline and 12, 24, 36 and 48 months. CSF collection, MRI, amyloid PET and tau PET will be conducted at baseline, and 24 and 48 months.

Brief summary: This research study aims to examine biomarkers of Alzheimer's disease (AD) as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Skåne University Hospital in Sweden. The study will enroll up to 600 cognitively healthy subjects aged 50 to 80 years with 3/4 having preclinical Alzheimer's disease. Recruitment and enrollment will be ongoing for 2-3 years, and subject participation will be lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure.


Eligibility criteria: Inclusion Criteria:

1. Age 50-80
2. Individuals aged 50-60 require at least one of the following risk factors for AD:

   1. Known APOE-E4 carrier
   2. Known 1st degree family history of dementia or severe memory loss with onset prior to 75.
   3. Known amyloid brain pathology by either CSF or PET scan.
3. Mini-Mental State Examination (MMSE) ≥26 (aged \>65); MMSE ≥27 (aged 50-65).
4. Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.
5. Speaks and understands Swedish to the extent that an interpreter is not necessary to fully understand the study information and cognitive tests.

6a. Preclinical AD subgroup (n=450): Amyloid pathology according to CSF AD biomarkers and Aβ-PET scans.

6b. Non-Preclinical AD subgroup (n=150): No sign of preclinical AD using CSF AD biomarkers or Aβ-PET scans.

Exclusion Criteria:

1. Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
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.
3. Major depression, bipolar disorder, or recurrent psychotic disorders within the past year.
4. History of alcohol and/or substance abuse or dependence within the past year.
5. Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
6. Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).

Primary outcomes:
measure: Change in cognitive function
timeFrame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
measure: Change in cognitive function - digital assessment
timeFrame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Secondary outcomes:
measure: Rate of change in plasma biomarkers
timeFrame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
measure: Rate of change in CSF biomarkers
timeFrame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
measure: Rate of change in amyloid PET
timeFrame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
measure: Rate of change in tau PET
timeFrame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
References: