Multimodal Assesment of Alzheimer Patients (MultiAD)

Norwegian University of Science and Technology

Status: Enrolling

Conditions: Cognitive Impairment; Mild Cognitive Impairment; Alzheimer Disease, Late Onset; Dementia

Treatments: Device: 64-channel EEG; Biological: Fecal samples; Behavioral: Cognitive tests; Device: MRI Scanning; Biological: Blood samples; Device: Polysomnography

Study type: Observational

Funder types: Other

Identifiers

NCT06448403

626476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

60 participants in 3 patient groups

MCI

Description:

Recruitment according to relevant clinical assessment and ICD-criterias.

Treatment:

Device: Polysomnography

Biological: Blood samples

Device: MRI Scanning

Behavioral: Cognitive tests

Biological: Fecal samples

Device: 64-channel EEG

Mild AD

Description:

Recruitment according to relevant clinical assessment and ICD-criterias.

Treatment:

Device: Polysomnography

Biological: Blood samples

Device: MRI Scanning

Behavioral: Cognitive tests

Biological: Fecal samples

Device: 64-channel EEG

Control

Description:

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

Treatment:

Device: Polysomnography

Biological: Blood samples

Device: MRI Scanning

Behavioral: Cognitive tests

Biological: Fecal samples

Device: 64-channel EEG