Alzheimer DiseaseMemADNCT07118137
Memory Deterioration in Alzheimer Disease
An observational study of Alzheimer Disease and Neurodegenerative Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Semantic AD Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Neurodegenerative Diseases, Magnetic Resonance Imaging
- What is being tested?
- 7T MRI, EEG and Blood samples
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 15 Oct 2023to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- Confirmed diagnosis based on current ICD criteria for AD or MCI .
- >55years.
- Norwegian native speaker
- Lives at home and not in a health institution
Who cannot join
- 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.
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- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Varanann Varathalingam contact
Norway1 site, 1 recruiting
- Recruiting
Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU)
Trondheim, Trønderlag, 7030
About this study
Official title: Translational Neuroscience CAG for Alzheimer's Disease
Semantic AD
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases, Magnetic Resonance Imaging, Memory Impairment
- Being tested
- 7T MRI, EEG, Blood samples, Stool samples, Neuropsychologic test (MoCA)
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRIDevice
Also called Magnetic Resonance imaging
Resting and activity-based MRI. Dring activity based MRI, the participant will complete tasks testing semantic memory.
EEGDevice
Also called Electrophysiology
Resting-state EEG
Blood samplesBiological
Blood samples taken for analysis of central blood biomarkers.
Stool samplesBiological
Also called Fecal Speciments
Stool samples collected to identify distinct gut-microbiota compositions between the groups.
Neuropsychologic test (MoCA)Diagnostic test
Map cognition with clinically well-established neuropsychology test
| Study group | Role | What they receive |
|---|---|---|
| Mild Alzheimer | Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias. Receives: Device: 7T MRI; Device: EEG; Biological: Blood samples; Biological: Stool samples; Diagnostic Test: Neuropsychologic test (MoCA) | |
| Controls | Age- and gender-matched control group. Receives: Device: 7T MRI; Device: EEG; Biological: Blood samples; Biological: Stool samples; Diagnostic Test: Neuropsychologic test (MoCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of follow-up time at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Sandvig Professor, MD PhD, Principal investigator, Norwegian University of Science and Technology (NTNU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118137
- Sponsor's protocol ID
- 490656
- Acronym
- MemAD
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymized.