Memory Deterioration in Alzheimer Disease

Recruiting

• Conditions: Alzheimer Disease; Neurodegenerative Diseases; Magnetic Resonance Imaging; Memory Impairment
• Interventions: Device: 7T MRI; Device: EEG; Biological: Blood samples; Biological: Stool samples; Diagnostic Test: Neuropsychologic test (MoCA)

• Registration Number: NCT07118137
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

Semantic AD

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-15
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild Alzheimer	7T MRI	Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
Mild Alzheimer	EEG	Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
Mild Alzheimer	Blood samples	Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
Mild Alzheimer	Stool samples	Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
Controls	7T MRI	Age- and gender-matched control group.
Mild Alzheimer	Neuropsychologic test (MoCA)	Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
Controls	EEG	Age- and gender-matched control group.
Controls	Blood samples	Age- and gender-matched control group.
Controls	Stool samples	Age- and gender-matched control group.
Controls	Neuropsychologic test (MoCA)	Age- and gender-matched control group.

Primary Outcome Measures

Name	Time	Method
Understand which individual differences are observed among patients with Alzheimer's disease (AD).	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.	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU); 🇳🇴 Trondheim, Trønderlag, Norway