Memory Deterioration in Alzheimer Disease

NCT07118137 | Recruiting

• 1 other identifier: 490656
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Semantic AD

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Magnetic Resonance Imaging; Memory Impairment

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Understand which individuals with mild cognitive impairment (MCI) go on to develop Alzheimer's disease (AD).

  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.

  From project encrollment to end of follow-up at 1 year.

Study Arms (2)

Mild Alzheimer

Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.

Device: 7T MRI; Device: EEG; Biological: Blood samples; Biological: Stool samples; Diagnostic Test: Neuropsychologic test (MoCA)

Controls

Age- and gender-matched control group.

Device: 7T MRI; Device: EEG; Biological: Blood samples; Biological: Stool samples; Diagnostic Test: Neuropsychologic test (MoCA)

Interventions

7T MRI DEVICE

Resting and activity-based MRI. Dring activity based MRI, the participant will complete tasks testing semantic memory.

Also known as: Magnetic Resonance imaging

Controls; Mild Alzheimer

EEG DEVICE

Resting-state EEG

Also known as: Electrophysiology

Controls; Mild Alzheimer

Blood samples BIOLOGICAL

Blood samples taken for analysis of central blood biomarkers.

Controls; Mild Alzheimer

Stool samples BIOLOGICAL

Stool samples collected to identify distinct gut-microbiota compositions between the groups.

Also known as: Fecal Speciments

Controls; Mild Alzheimer

Neuropsychologic test (MoCA) DIAGNOSTIC_TEST

Map cognition with clinically well-established neuropsychology test

Controls; Mild Alzheimer

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Confirmed diagnosis based on current ICD criteria for AD or MCI .
• \>55years.
• Norwegian native speaker
• Lives at home and not in a health institution

You may not qualify if:

• 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.
• T 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.)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU)

Trondheim, Trønderlag, 7030, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples * Fecal samples All samples will be anonymized and safed according to GDPR and ethical guidelines given by regional ethical commitee.

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Memory Disorders

Interventions

Magnetic Resonance Imaging; Electroencephalography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Axel Sandvig Professor, MD PhD

  Norwegian University of Science and Technology (NTNU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Sandvig Professor, MD & PhD

CONTACT

+4745840578; axel.sandvig@ntnu.no

Varanann Varathalingam

CONTACT

varananv@ntnu.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 12, 2025
• Study Start: October 15, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)