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
- Are there results?
- Not yet: the study is under way
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.
Show all 10Show fewer
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Neuroscience CAG for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07118137
- Acronym / sponsor ID
- MemAD / 490656
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases, Magnetic Resonance Imaging, Memory Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Semantic AD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Alzheimer | – | Device: 7T MRI, Device: EEG, Biological: Blood samples, Biological: Stool samples, Diagnostic Test: Neuropsychologic test (MoCA)Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias. |
| Controls | – | Device: 7T MRI, Device: EEG, Biological: Blood samples, Biological: Stool samples, Diagnostic Test: Neuropsychologic test (MoCA)Age- and gender-matched control group. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Confirmed diagnosis based on current ICD criteria for AD or MCI .
- >55years.
- Norwegian native speaker
- Lives at home and not in a health institution
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7T MRIAlso: Magnetic Resonance imagingResting and activity-based MRI. Dring activity based MRI, the participant will complete tasks testing semantic memory. | Device | Controls, Mild Alzheimer |
| EEGAlso: ElectrophysiologyResting-state EEG | Device | Controls, Mild Alzheimer |
| Blood samplesBlood samples taken for analysis of central blood biomarkers. | Biological | Controls, Mild Alzheimer |
| Stool samplesAlso: Fecal SpecimentsStool samples collected to identify distinct gut-microbiota compositions between the groups. | Biological | Controls, Mild Alzheimer |
| Neuropsychologic test (MoCA)Map cognition with clinically well-established neuropsychology test | Diagnostic test | Controls, Mild Alzheimer |
Primary outcome
Understand which individual differences are observed among patients with Alzheimer's disease (AD).
Time frame: From enrollment to end of follow-up at 1 year.
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.
Compare changes in the brain, blood, and stool samples between dementia patients and healthy controls.
Time frame: From project enrollment to end of follow-up at 1 year.
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.
1 secondary outcome
Understand which individuals with mild cognitive impairment (MCI) go on to develop Alzheimer's disease (AD).
Time frame: From enrollment to the end of follow-up time at 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. All data will be anonymized.
Related trials for Alzheimer Disease
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Varanann Varathalingam contact
Axel Sandvig Professor, MD PhD principal investigator
Norwegian University of Science and Technology (NTNU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Neurodegenerative Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Sandvig Professor, MD & PhD (+4745840578, axel.sandvig@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand which individual differences are observed among patients with Alzheimer's disease (AD). (time frame: From enrollment to end of follow-up at 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.