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Recruiting

NCT Number: NCT07118137

Memory Deterioration in Alzheimer Disease

Semantic AD

Recruiting

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Magnetic Resonance Imaging Memory Disorders Memory Impairment Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Trondheim, Trønderlag, 7030, Norway

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.)

Treatment and study plan

7t MRI

Device

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

Other names: Magnetic Resonance imaging

EEG

Device

Resting-state EEG

Other names: Electrophysiology

blood samples

Biological

Blood samples taken for analysis of central blood biomarkers.

Stool samples

Biological

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

Other names: Fecal Speciments

Neuropsychologic test (MoCA)

Diagnostic Test

Map cognition with clinically well-established neuropsychology test

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

    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.

Other outcomes

  1. Compare brain changes in patients with Alzheimer's disease (AD) to those with other types of dementia.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Sandvig Professor, MD & PhD

CONTACT

[email protected]

+4745840578

Varanann Varathalingam

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Translational Neuroscience CAG for Alzheimer's Disease

Acronym: MemAD

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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