Skåne University Hospital
Malmö, Sweden
Location status: Recruiting
Location contact
Erik Stomrud, MD, PhD
CONTACT
NCT Number: NCT06121544
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Observational
Malmö, Sweden
Location status: Recruiting
Erik Stomrud, MD, PhD
CONTACT
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
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 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.
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.
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Contact information is provided by the study sponsor or research team.
Erik Stomrud, MD, PhD
CONTACT
Niklas Mattsson-Carlgren, MD, PhD
CONTACT
Skane University Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06120361
Alzheimer Disease, Arterial Occlusive Diseases
Malmö, Sweden
View Trial DetailsNCT03174938
ALS (Amyotrophic Lateral Sclerosis), Alzheimer Disease
Ängelholm, Sweden
View Trial DetailsNCT06122415
Alzheimer Disease, Arterial Occlusive Diseases
Malmö, Sweden
View Trial DetailsNCT05138263
Alzheimer Disease, Brain Diseases
Seoul, South Korea
View Trial Details