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Clinical Trials/NCT06448403
NCT06448403
Recruiting
N/A

Multimodal Assessment of Cognitive Impairment in Alzheimer Patients

Norwegian University of Science and Technology1 site in 1 country60 target enrollmentJuly 1, 2024

Overview

Phase
N/A
Intervention
64-channel EEG
Conditions
Mild Cognitive Impairment
Sponsor
Norwegian University of Science and Technology
Enrollment
60
Locations
1
Primary Endpoint
AD-subclassification
Status
Recruiting
Last Updated
8 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
December 29, 2030
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Arms & Interventions

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: 64-channel EEG

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Polysomnography

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Blood samples

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Fecal samples

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: MRI Scanning

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Cognitive tests

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: MRI Scanning

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: 64-channel EEG

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Polysomnography

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Blood samples

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Fecal samples

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Intervention: Cognitive tests

Control

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

Intervention: MRI Scanning

Control

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

Intervention: 64-channel EEG

Control

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

Intervention: Polysomnography

Control

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

Intervention: Blood samples

Control

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

Intervention: Fecal samples

Control

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

Intervention: Cognitive tests

Outcomes

Primary Outcomes

AD-subclassification

Time Frame: 5 years

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

MCI-AD converters

Time Frame: 5 years

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

Study Sites (1)

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