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Semantic AD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Alzheimer | Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias. |
| |
| Controls | Age- and gender-matched control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7T MRI | Device | Resting and activity-based MRI. Dring activity based MRI, the participant will complete tasks testing semantic memory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of follow-up at 1 year. |
| 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. | From project enrollment to end of follow-up at 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of follow-up time at 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From project encrollment to end of follow-up at 1 year. |
Inclusion Criteria:
Exclusion Criteria:
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.
Contraindications to the selected imaging modalities (e.g., 7T MRI or EEG).
Diagnosis of other neurodegenerative diseases such as Parkinson's disease or ALS.
7T MRI contraindications:
Large tattoos close to the head region, permanent makeup or unremoveable piercings
Certain models of pacemakers (if pacemaker implantet, MRI physicist at 7T-lab will be conferred)
Implantet metal in body (clips, stents, prothesis, skrews, plates, teeth etc.)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Sandvig Professor, MD & PhD | Contact | +4745840578 | axel.sandvig@ntnu.no | |
| Varanann Varathalingam | Contact | varananv@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Axel Sandvig Professor, MD PhD | Norwegian University of Science and Technology (NTNU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU) | Recruiting | Trondheim | Trønderlag | 7030 | Norway |
All data will be anonymized.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D019636 | Neurodegenerative Diseases |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D004569 | Electroencephalography |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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All samples will be anonymized and safed according to GDPR and ethical guidelines given by regional ethical commitee.
|
| EEG | Device | Resting-state EEG |
|
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| Blood samples | Biological | Blood samples taken for analysis of central blood biomarkers. |
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| Stool samples | Biological | Stool samples collected to identify distinct gut-microbiota compositions between the groups. |
|
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| Neuropsychologic test (MoCA) | Diagnostic Test | Map cognition with clinically well-established neuropsychology test |
|
| D024801 |
| Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003943 |
| Diagnostic Techniques, Neurological |
| D004568 | Electrodiagnosis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |