An observational study in Alzheimer Disease, Mild Cognitive Impairment and Mild Dementia, sponsored by Skane University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Skane University Hospital · Observational
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 800 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Skane University Hospital is the lead sponsor of 73 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals aged 50-60 require at least one of the following risk factors for AD:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Diagnostic Test: Plasma tau · Diagnostic Test: Plasma β-Amyloid 42/40 (Aβ42/Aβ40) · Diagnostic Test: Flutemetamol F18 Injection · Diagnostic Test: [18F]-RO6958948 Injection · Diagnostic Test: Magnetic resonance imaging (MRI)
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Diagnostic Test: Plasma tau · Diagnostic Test: Plasma β-Amyloid 42/40 (Aβ42/Aβ40) · Diagnostic Test: Flutemetamol F18 Injection · Diagnostic Test: [18F]-RO6958948 Injection · Diagnostic Test: Magnetic resonance imaging (MRI)
Plasma levels of different p-tau and np-tau species
Plasma levels of Aβ42/Aβ40 ratio
Positron emission tomography (PET) imaging of amyloid-β plaques
PET imaging of Tau aggregates
Different MRI sequences relevant for brain imaging
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.
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.
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.
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.
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.
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.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Within one year after study completion
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Skane University Hospital