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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06121544
Other study ID # SAIS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Skane University Hospital
Contact Oskar Hansson, MD, PhD
Phone +46-40-331000
Email oskar.hansson@med.lu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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Study Design


Intervention

Diagnostic Test:
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-ß plaques
[18F]-RO6958948 Injection
PET imaging of Tau aggregates
Magnetic resonance imaging (MRI)
Different MRI sequences relevant for brain imaging

Locations

Country Name City State
Sweden Skåne University Hospital Malmö

Sponsors (2)

Lead Sponsor Collaborator
Skane University Hospital Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cognitive function Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC) Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Primary Change in cognitive function - digital assessment Rate of cognitive decline as measured by digital cognitive assessments Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Secondary 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.
Secondary Rate of change in CSF biomarkers Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Secondary 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.
Secondary 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.
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