Health TrialsbyHealthPanel

The Swedish BioFINDER - Preclinical AD Study

ConditionsAlzheimer DiseaseMild Cognitive ImpairmentMild Dementia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorSkane University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 50-80

Known apolipoprotein E (APOE) -ε4 carrier

Known 1st degree family history of dementia or severe memory loss with onset prior to 75.

Known amyloid brain pathology by either CSF or PET scan.

Disqualifiers

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.

Trial population

Cognitively unimpaired individuals (50-80 years old) Step 1. Cognitively normal individuals will be screened using plasma p-tau217 (Eli Lilly-developed Meso Scale Discovery method). Step 2. Cerebrospinal fluid Alzheimer's disease biomarkers analysis 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 Alzheimer's disease biomarkers and 150 with normal Alzheimer's disease 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. cerebrospinal fluid collection, MRI, amyloid PET and tau PET will be conducted at baseline, and 24 and 48 months.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Plasma tau

    Diagnostic test

    Plasma levels of different p-tau and np-tau species

  • Plasma β-Amyloid 42/40 (Aβ42/Aβ40)

    Diagnostic test

    Plasma levels of Aβ42/Aβ40 ratio

  • Flutemetamol F18 Injection

    Diagnostic test

    Positron emission tomography (PET) imaging of amyloid-β plaques

  • [18F]-RO6958948 Injection

    Diagnostic test

    PET imaging of Tau aggregates

  • Magnetic resonance imaging (MRI)

    Diagnostic test

    Different MRI sequences relevant for brain imaging

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Cognitively unimpaired individuals with preclinical Alzheimer's disease5 interventions
Group B: Cognitively unimpaired individuals without preclinical Alzheimer's disease.5 interventions

Trial outcomes

Primary outcomes

1

Change in cognitive function

Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
2

Change in cognitive function - digital assessment

Rate of cognitive decline as measured by digital cognitive assessments

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.

Secondary outcomes

1

Rate of change in plasma biomarkers

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
2

Rate of change in cerebrospinal fluid biomarkers

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
3

Rate of change in amyloid PET

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
4

Rate of change in tau PET

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Skane University Hospital

Lead sponsor

Lund University

Collaborator

Source ClinicalTrials.gov
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