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Recruiting NCT06448403

Multimodal Assesment of Alzheimer Patients

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

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: MRI Scanning, 64-channel EEG, Polysomnography, Blood samples.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Alzheimer Disease, Late Onset, Cognitive Impairment, Dementia. Basic parameters: from 65 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

Multimodal Assessment of Cognitive Impairment in Alzheimer Patients

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • MCI-AD converters [Time frame: 5 years]
  • AD-subclassification [Time frame: 5 years]

Eligibility criteria

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)

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: NCT06448403 · 626476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗