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NCT Number: NCT06448403

Multimodal Assesment of 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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer Disease, Late Onset Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

MRI scanning

Device

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

64-channel EEG

Device

EEG to quantifiy electric activity.

Polysomnography

Device

A randomized group will undergo polysomnography.

blood samples

Biological

Analysis of specific blood biomarkers.

Fecal samples

Biological

Analysis of bacterial composition.

Cognitive tests

Behavioral

Interview-based cognitive tests for assesment of cognitive levels.

Primary outcomes

  1. MCI-AD converters

    Time frame: 5 years

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

  2. AD-subclassification

    Time frame: 5 years

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

Study contacts

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

Axel Sandvig, Prof., MD, PhD

CONTACT

[email protected]

72 57 56 20

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Multimodal Assessment of Cognitive Impairment in Alzheimer Patients

Acronym: MultiAD

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 7, 2024
Registry last updated
Aug 7, 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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