Memory Deterioration in Alzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorNorwegian University of Science and Technology
About this trial
Semantic AD
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Confirmed diagnosis based on current ICD criteria for AD or MCI .
>55years.
Norwegian native speaker
Lives at home and not in a health institution
Disqualifiers
Patients with severe cognitive impairment that prevents assessment with the selected modalities (planned cut-off: CDR > 2).
Presence of brain tumors.
History of traumatic brain injury.
History of cranial surgery.
Trial population
Participants will be recruited from the region of Trøndelag, Norway. The study population will include individuals with cognitive symptoms as well as cognitively healthy, age- and sex-matched controls. Recruitment will take place through memory clinics and primary care services. All participants will undergo standardized assessments and data collection as specified in the study protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
7T MRI
DeviceResting and activity-based MRI. Dring activity based MRI, the participant will complete tasks testing semantic memory.
EEG
DeviceResting-state EEG
Blood samples
Biological/VaccineBlood samples taken for analysis of central blood biomarkers.
Stool samples
Biological/VaccineStool samples collected to identify distinct gut-microbiota compositions between the groups.
Neuropsychologic test (MoCA)
Diagnostic testMap cognition with clinically well-established neuropsychology test
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Mild Alzheimer5 interventions
Group B: Controls5 interventions
Trial outcomes
Primary outcomes
1
Understand which individual differences are observed among patients with Alzheimer's disease (AD).
This outcome will characterize individual variability among patients diagnosed with Alzheimer's disease based on clinical symptoms, cognitive assessments, neuroimaging findings (7T MRI), electrophysiological data (EEG), and biological samples (blood and stool). The goal is to identify patterns or subtypes that may reflect distinct disease mechanisms or progression profiles.
Time frame
From enrollment to end of follow-up at 1 year.2
Compare changes in the brain, blood, and stool samples between dementia patients and healthy controls.
Assess differences between dementia patients and cognitively healthy controls using multimodal data, including 7T MRI for brain structure, EEG, blood biomarkers, and gut microbiome profiles from stool samples. The aim is to identify biological and neurological markers associated with dementia-related changes.
Time frame
From project enrollment to end of follow-up at 1 year.Secondary outcomes
1
Understand which individuals with mild cognitive impairment (MCI) go on to develop Alzheimer's disease (AD).
Identify early clinical, neuroimaging, and biological markers associated with progression from MCI to AD. This research question aims to improve early diagnosis and risk stratification in individuals with MCI.
Time frame
From enrollment to the end of follow-up time at 1 year.Other outcomes
1
Compare brain changes in patients with Alzheimer's disease (AD) to those with other types of dementia.
This outcome will investigate brain changes in patients with Alzheimer's disease compared to those with other dementia types using the different modalities included in the project.
Time frame
From project encrollment to end of follow-up at 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov