Multimodal brain testing for Alzheimer’s and mild cognitive impairment
Multimodal Assessment of Cognitive Impairment in Alzheimer Patients
This project will use MRI, EEG, sleep studies, and blood and stool tests to try to find brain and bodily changes that predict or distinguish Alzheimer’s disease and mild cognitive impairment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology Academic / other |
| Locations | 1 site (Trondheim, Trønderlag) |
| Trial ID | NCT06448403 on ClinicalTrials.gov |
What this trial studies
This observational project combines cognitive testing, structural and functional MRI, 64-channel EEG, randomized polysomnography in a subgroup, and blood and fecal sampling to map brain and systemic changes in people with late-onset Alzheimer’s disease, mild cognitive impairment, and matched healthy controls. Imaging will be analyzed for structural and functional alterations while EEG will measure changes in electrical activity, and polysomnography will characterize sleep-related features. Blood samples will be tested for dementia- and inflammation-related proteins and fecal samples will be analyzed for gut microbiome composition. Cognitive testing will link clinical performance to the biological and neurophysiological measures to identify markers that precede clinical decline or distinguish patient groups.
Who should consider this trial
Good fit: Adults aged 65 or older diagnosed with mild cognitive impairment or late-onset Alzheimer’s disease, and age- and sex-matched healthy controls who can undergo MRI and EEG, are ideal candidates.
Not a fit: People with early-onset AD (diagnosed before age 65), other neurodegenerative disorders, brain tumors, prior neurosurgery, major traumatic brain injury, inflammatory/autoimmune diseases, or who cannot undergo MRI/EEG are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this work could enable earlier and more accurate detection of Alzheimer’s-related decline and identify biological signals useful for tracking disease progression.
How similar studies have performed: Previous multimodal biomarker studies combining imaging, electrophysiology, and blood markers have shown promising leads but no single multimodal signature has yet become a definitive clinical diagnostic tool.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * MCI and AD according to relevant ICD-criterias. * Control cohort is age and gender matched with other cohorts. Exclusion Criteria: * Uneligibility for any of the planned neuroimagery devices (MRI, EEG) * AD diagnosis before the age of 65 (Early-onset AD). * Brain tumor * Traumtic head injury * Earlier neurosurgery * Other neyrodegenerative diseases (i.e Parkinson and ALS) * Diseases related to inflammation and auto-immunity (i.e MS)
Where this trial is running
Trondheim, Trønderlag
- Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU) — Trondheim, Trønderlag, Norway (Recruiting)
Study contacts
- Principal investigator: Axel Sandvig, Prof., MD, PhD — Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital
- Study coordinator: Axel Sandvig, Prof., MD, PhD
- Email: axel.sandvig@ntnu.no
- Phone: 72 57 56 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.