The Swedish BioFINDER - Preclinical AD Study

Alzheimer Disease Clinical Trial

Official title:

The Swedish BioFINDER - Preclinical AD Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121544
• Other study ID #: SAIS
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Skane University Hospital
• Contact: Oskar Hansson, MD, PhD
• Phone: +46-40-331000
• Email: oskar.hansson[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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 Aß-PET scans.

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild Dementia

Intervention

Diagnostic Test:
• Plasma tau
Plasma levels of different p-tau and np-tau species
• Plasma Ab42/Ab40
Plasma levels of Ab42/Ab40 ratio
• Flutemetamol F18 Injection
Positron emission tomography (PET) imaging of amyloid-ß plaques
• [18F]-RO6958948 Injection
PET imaging of Tau aggregates
• Magnetic resonance imaging (MRI)
Different MRI sequences relevant for brain imaging

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Skane University Hospital	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

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