The Swedish BioFINDER - Preclinical AD Study

Skane University Hospital

Status

Enrolling

Conditions

Alzheimer Disease

Mild Dementia

Mild Cognitive Impairment

Treatments

Diagnostic Test: Magnetic resonance imaging (MRI)

Diagnostic Test: Flutemetamol F18 Injection

Diagnostic Test: [18F]-RO6958948 Injection

Diagnostic Test: Plasma tau

Diagnostic Test: Plasma Ab42/Ab40

Study type

Observational

Funder types

Other

Identifiers

NCT06121544

SAIS

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 50-80
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.
Mini-Mental State Examination (MMSE) ≥26 (aged >65); MMSE ≥27 (aged 50-65).
Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.
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

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