Multimodal Assesment of Alzheimer Patients

Not yet recruiting

• Conditions: Alzheimer Disease, Late Onset; Cognitive Impairment; Dementia; Mild Cognitive Impairment
• Interventions: Device: MRI Scanning; Device: 64-channel EEG; Device: Polysomnography; Biological: Blood samples; Biological: Fecal samples; Behavioral: Cognitive tests

• Registration Number: NCT06448403
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Study Start: 2024-07-01
• Primary Completion: 2030-12-29
• Study Completion: 2030-12-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild AD	Fecal samples	Recruitment according to relevant clinical assessment and ICD-criterias.
MCI	MRI Scanning	Recruitment according to relevant clinical assessment and ICD-criterias.
MCI	64-channel EEG	Recruitment according to relevant clinical assessment and ICD-criterias.
MCI	Cognitive tests	Recruitment according to relevant clinical assessment and ICD-criterias.
MCI	Blood samples	Recruitment according to relevant clinical assessment and ICD-criterias.
Mild AD	Cognitive tests	Recruitment according to relevant clinical assessment and ICD-criterias.
Control	Fecal samples	Equivalent number of research participants as in the MCI and mild AD group.
Mild AD	64-channel EEG	Recruitment according to relevant clinical assessment and ICD-criterias.
Mild AD	Blood samples	Recruitment according to relevant clinical assessment and ICD-criterias.
MCI	Polysomnography	Recruitment according to relevant clinical assessment and ICD-criterias.
MCI	Fecal samples	Recruitment according to relevant clinical assessment and ICD-criterias.
Mild AD	Polysomnography	Recruitment according to relevant clinical assessment and ICD-criterias.
Control	MRI Scanning	Equivalent number of research participants as in the MCI and mild AD group.
Control	Polysomnography	Equivalent number of research participants as in the MCI and mild AD group.
Mild AD	MRI Scanning	Recruitment according to relevant clinical assessment and ICD-criterias.
Control	64-channel EEG	Equivalent number of research participants as in the MCI and mild AD group.
Control	Blood samples	Equivalent number of research participants as in the MCI and mild AD group.
Control	Cognitive tests	Equivalent number of research participants as in the MCI and mild AD group.

Primary Outcome Measures

Name	Time	Method
AD-subclassification	5 years	Identify biomarker profiles that can assist in a more thorough AD-classification
MCI-AD converters	5 years	Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.