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Recruiting NCT07118137

Memory Deterioration in Alzheimer Disease

Observational Alzheimer Disease Neurodegenerative Diseases Magnetic Resonance Imaging Memory Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 7T MRI, EEG, Blood samples, Stool samples.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Neurodegenerative Diseases, Magnetic Resonance Imaging, Memory Impairment. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Translational Neuroscience CAG for Alzheimer's Disease

Overview

Semantic AD

Interventions

  • Device 7T MRI
    Resting and activity-based MRI. Dring activity based MRI, the participant will complete tasks testing semantic memory.
  • Device EEG
    Resting-state EEG
  • Biological Blood samples
    Blood samples taken for analysis of central blood biomarkers.
  • Biological Stool samples
    Stool samples collected to identify distinct gut-microbiota compositions between the groups.
  • Diagnostic test Neuropsychologic test (MoCA)
    Map cognition with clinically well-established neuropsychology test

Primary outcome measures

  • 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.]
  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Norway · 1 center
  • Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige univers — Trondheim

Identifiers

NCT: NCT07118137 · 490656

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗