Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2022-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
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-β plaques
[18F]-RO6958948 Injection
PET imaging of Tau aggregates
Magnetic resonance imaging (MRI)
Different MRI sequences relevant for brain imaging
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
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-β plaques
[18F]-RO6958948 Injection
PET imaging of Tau aggregates
Magnetic resonance imaging (MRI)
Different MRI sequences relevant for brain imaging
Interventions
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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-β plaques
[18F]-RO6958948 Injection
PET imaging of Tau aggregates
Magnetic resonance imaging (MRI)
Different MRI sequences relevant for brain imaging
Eligibility Criteria
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Inclusion Criteria
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
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).
50 Years
80 Years
ALL
No
Sponsors
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Lund University
OTHER
Skane University Hospital
OTHER
Responsible Party
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Erik Stomrud
M.D., PhD
Locations
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Skåne University Hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Erik Stomrud, MD, PhD
Role: primary
Other Identifiers
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SAIS
Identifier Type: -
Identifier Source: org_study_id
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