The Swedish BioFINDER - Preclinical AD Study

Plain English Summary

The Swedish BioFINDER - Preclinical AD Study is a Not Applicable clinical trial sponsored by Skane University Hospital studying Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia. This study looks for early signs of Alzheimer's disease using biomarkers in the blood and brain scans. It is for individuals aged 50-80 who may be at risk for or showing early signs of Alzheimer's. Participation involves regular visits for cognitive tests, blood draws, and brain imaging over 4 years. Currently, there are no widely available screening tools for preclinical Alzheimer's; this study aims to develop one. The trial aims to enroll 800 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 80 years old. If you are between 50-60, you need at least one risk factor for Alzheimer's (like a gene, family history, or early brain changes). You should have good cognitive function, with specific scores on memory tests. You must be able to understand and speak Swedish without an interpreter. This trial is studying Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures track changes in cognitive function over time, meaning the study will see if participants' memory and thinking abilities change, helping to understand the disease's progre The specific primary outcome measures are: 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.); 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.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it seeks to identify Alzheimer's disease at its earliest, preclinical stages, potentially leading to a screening tool for the general population. This research targets Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia, where improved treatment options are needed.

Investor Insight

This observational study focuses on biomarker development for early Alzheimer's detection, a significant unmet need, suggesting potential future diagnostic market opportunities. The large enrollment target of 800 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about your personal risk factors for Alzheimer's and if this study is a good fit for you. Be prepared for multiple visits over 4 years, including cognitive tests, blood draws, and brain scans (MRI and PET). Disclosure of your Alzheimer's risk assessment results is optional. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 800 participants

Interventions

• DIAGNOSTIC_TEST: Plasma tau — Plasma levels of different p-tau and np-tau species
• DIAGNOSTIC_TEST: Plasma β-Amyloid 42/40 (Aβ42/Aβ40) — Plasma levels of Aβ42/Aβ40 ratio
• DIAGNOSTIC_TEST: Flutemetamol F18 Injection — Positron emission tomography (PET) imaging of amyloid-β plaques
• DIAGNOSTIC_TEST: [18F]-RO6958948 Injection — PET imaging of Tau aggregates
• DIAGNOSTIC_TEST: Magnetic resonance imaging (MRI) — Different MRI sequences relevant for brain imaging

Primary Outcomes

• 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.)
• 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.)

Secondary Outcomes

• 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 cerebrospinal fluid 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.)

Full 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 apolipoprotein E (APOE) -ε4 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 Alzheimer's disease subgroup (n=450): Amyloid pathology according to cerebrospinal fluid Alzheimer's disease and amyloid PET scans.

6b. Non-Preclinical Alzheimer's disease subgroup (n=150): No sign of preclinical Alzheimer's disease using cerebrospinal fluid Alzheimer's disease 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).

Trial Locations

• Skåne University Hospital, Malmo, Sweden

Frequently Asked Questions

Related Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Mild Dementia
• Neurocognitive Disorders
• Dementia
• Memory Loss
• Apolipoprotein E (APOE) -ε4
• Amyloid Pathology
• Tau Pathology
• Neurodegenerative Disease

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