Multimodal Assesment of Alzheimer Patients (MultiAD)

August 4, 2025 updated by: Norwegian University of Science and Technology

Multimodal Assessment of Cognitive Impairment in Alzheimer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
Device: MRI Scanning
MRI scanning with volumetric, resting and activity-based sequences.
Device: 64-channel EEG
EEG to quantifiy electric activity.
Device: Polysomnography
A randomized group will undergo polysomnography.
Biological: Blood samples
Analysis of specific blood biomarkers.
Biological: Fecal samples
Analysis of bacterial composition.
Behavioral: Cognitive tests
Interview-based cognitive tests for assesment of cognitive levels.
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
Device: MRI Scanning
MRI scanning with volumetric, resting and activity-based sequences.
Device: 64-channel EEG
EEG to quantifiy electric activity.
Device: Polysomnography
A randomized group will undergo polysomnography.
Biological: Blood samples
Analysis of specific blood biomarkers.
Biological: Fecal samples
Analysis of bacterial composition.
Behavioral: Cognitive tests
Interview-based cognitive tests for assesment of cognitive levels.
Control
Equivalent number of research participants as in the MCI and mild AD group.
Device: MRI Scanning
MRI scanning with volumetric, resting and activity-based sequences.
Device: 64-channel EEG
EEG to quantifiy electric activity.
Device: Polysomnography
A randomized group will undergo polysomnography.
Biological: Blood samples
Analysis of specific blood biomarkers.
Biological: Fecal samples
Analysis of bacterial composition.
Behavioral: Cognitive tests
Interview-based cognitive tests for assesment of cognitive levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MCI-AD converters
Time Frame: 5 years
Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.
5 years
AD-subclassification
Time Frame: 5 years
Identify biomarker profiles that can assist in a more thorough AD-classification
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Axel Sandvig, Prof., MD, PhD, Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 29, 2030

Study Completion (Estimated)

December 29, 2030

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 626476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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