Multimodal Assesment of Alzheimer Patients

ConditionsMild Cognitive Impairment Alzheimer Disease, Late Onset Cognitive Impairment Dementia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age65+

SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

MCI and AD according to relevant ICD-criterias.

Control cohort is age and gender matched with other cohorts.

Disqualifiers

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

Trial population

The study population is from Tronderlag in Norway, mainly in and around Trondheim city.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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/Vaccine
Analysis of specific blood biomarkers.
Fecal samples
Biological/Vaccine
Analysis of bacterial composition.
Cognitive tests
Behavioral
Interview-based cognitive tests for assesment of cognitive levels.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: MCI6 interventions

Group B: Mild AD6 interventions

Group C: Control6 interventions

Trial outcomes

Primary outcomes

MCI-AD converters

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

Time frame

5 years

AD-subclassification

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

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norwegian University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

Apply now