The Swedish BioFINDER - Preclinical AD Study

Recruiting

• Conditions: Mild Dementia; Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Diagnostic Test: Plasma tau; Diagnostic Test: Plasma Ab42/Ab40; Diagnostic Test: Flutemetamol F18 Injection; Diagnostic Test: [18F]-RO6958948 Injection; Diagnostic Test: Magnetic resonance imaging (MRI)

• Registration Number: NCT06121544
• Lead Sponsor: Skane University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cognitively unimpaired individuals with preclinical Alzheimer's disease	Plasma Ab42/Ab40	75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals with preclinical Alzheimer's disease	[18F]-RO6958948 Injection	75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals with preclinical Alzheimer's disease	Plasma tau	75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals with preclinical Alzheimer's disease	Flutemetamol F18 Injection	75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.	Flutemetamol F18 Injection	25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.	[18F]-RO6958948 Injection	25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Cognitively unimpaired individuals with preclinical Alzheimer's disease	Magnetic resonance imaging (MRI)	75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.	Plasma tau	25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.	Magnetic resonance imaging (MRI)	25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.	Plasma Ab42/Ab40	25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.

Primary Outcome Measures

Name	Time	Method
Change in cognitive function	Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.	Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)
Change in cognitive function - digital assessment	Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.	Rate of cognitive decline as measured by digital cognitive assessments

Secondary Outcome Measures

Name	Time	Method
Rate of change in plasma biomarkers	Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in CSF biomarkers	Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Rate of change in amyloid PET	Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Rate of change in tau PET	Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Malmö, Sweden