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RecruitingNCT06448403MultiADUpdated Aug 13, 2026

Multimodal Assesment of Alzheimer Patients

An observational study in Mild Cognitive Impairment, Alzheimer Disease, Late Onset and Cognitive Impairment, sponsored by Norwegian University of Science and Technology. Recruiting at 1 site in Norway. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Norwegian University of Science and Technology · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
65 Years and older
Sex
All
01

Study summary

The goal of this study is to learn more about the changes in the brains of patients with cognitive impairment (MCI) and Alzheimer's Disease (AD).

The main questions the study aims to answer are:

  1. What findings can be used to earlier detect patients that will develop Alzheimers?
  2. Which differences are seen between healthy and cognitively impaired patients?
  3. Which differences are seen between patients with Alzheimers disease?

Participants will undergo:

  • Cognitive tests
  • Magnetic resonance imaging (MRI)
  • Electroencephalography (EEG)
  • Blood sample collection
  • Fecal sample collection
  • A randomized group will undergo polysomnography analysis.
Read the detailed description

The projects aims to map brain changes in patients with mild cognitive impairment (MCI) and Alzheimer's Disease (AD) by combining different assesment modalities.

In the MRI, researchers will get the opportunity to analyse both structural and functional brain changes. In the EEG, changes in elctrical activites will be measured. The blood samples allow researchers to analyse specific dementia and inflammation proteins, while fecal speciments can be used to assess bacterial composition. Additionally, the cognitive testing allow to assess the specific part of cognitive function which is affected.

02

Conditions studied

  • Mild Cognitive Impairment
  • Alzheimer Disease, Late Onset
  • Cognitive Impairment
  • Dementia

Keywords

  • Alzheimer Disease (AD)
  • Mild cognitive impairment (MCI)
  • Brain Diseases
  • Nervous System Disorders
  • Neurodegenerative Diseases
  • Dementia
  • Cognitive impairment
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population is from Tronderlag in Norway, mainly in and around Trondheim city.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • MCI and AD according to relevant ICD-criterias.
  • Control cohort is age and gender matched with other cohorts.

Exclusion criteria

Exclusion Criteria:

  • Uneligibility for any of the planned neuroimagery devices (MRI, EEG)
  • AD diagnosis before the age of 65 (Early-onset AD).
  • Brain tumor
  • Traumtic head injury
  • Earlier neurosurgery
  • Other neyrodegenerative diseases (i.e Parkinson and ALS)
  • Diseases related to inflammation and auto-immunity (i.e MS)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • MCI

    Recruitment according to relevant clinical assessment and ICD-criterias.

    Device: MRI Scanning · Device: 64-channel EEG · Device: Polysomnography · Biological: Blood samples · Biological: Fecal samples · Behavioral: Cognitive tests

  • Mild AD

    Recruitment according to relevant clinical assessment and ICD-criterias.

    Device: MRI Scanning · Device: 64-channel EEG · Device: Polysomnography · Biological: Blood samples · Biological: Fecal samples · Behavioral: Cognitive tests

  • Control

    Equivalent number of research participants as in the MCI and mild AD group.

    Device: MRI Scanning · Device: 64-channel EEG · Device: Polysomnography · Biological: Blood samples · Biological: Fecal samples · Behavioral: Cognitive tests

Interventions

  • DeviceMRI Scanning

    MRI scanning with volumetric, resting and activity-based sequences.

  • Device64-channel EEG

    EEG to quantifiy electric activity.

  • DevicePolysomnography

    A randomized group will undergo polysomnography.

  • BiologicalBlood samples

    Analysis of specific blood biomarkers.

  • BiologicalFecal samples

    Analysis of bacterial composition.

  • BehavioralCognitive tests

    Interview-based cognitive tests for assesment of cognitive levels.

06

What researchers measure

Primary outcomes

  1. MCI-AD converters

    Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.

    Time frame: 5 years

  2. AD-subclassification

    Identify biomarker profiles that can assist in a more thorough AD-classification

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU)
    Trondheim, Trønderlag 7030, Norway
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06448403
Responsible party
Sponsor
First posted
Jun 7, 2024
Start date
Jul 1, 2024
Primary completion
Dec 29, 2030 (estimated)
Completion
Dec 29, 2030 (estimated)
Last update
Aug 13, 2026

Study contacts

Axel Sandvig, Prof., MD, PhD
Contact
axel.sandvig@ntnu.no
72 57 56 20
Axel Sandvig, Prof., MD, PhD
principal investigator · Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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