Multimodal Assesment of Alzheimer Patients

Dementia Clinical Trial

— MultiAD  

Official title:

Multimodal Assessment of Cognitive Impairment in Alzheimer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448403
• Other study ID #: 626476
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 29, 2030

Study information

• Verified date: June 2024
• Source: Norwegian University of Science and Technology
• Contact: Axel Sandvig, Prof., MD, PhD
• Phone: 72 57 56 20
• Email: axel.sandvig[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 29, 2030
• Est. primary completion date: December 29, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Late Onset
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Mild Cognitive Impairment

Intervention

Device:
• MRI Scanning
MRI scanning with volumetric, resting and activity-based sequences.
• 64-channel EEG
EEG to quantifiy electric activity.
• Polysomnography
A randomized group will undergo polysomnography.

Biological:
• Blood samples
Analysis of specific blood biomarkers.
• Fecal samples
Analysis of bacterial composition.

Behavioral:
• Cognitive tests
Interview-based cognitive tests for assesment of cognitive levels.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MCI-AD converters	Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.	5 years
Primary	AD-subclassification	Identify biomarker profiles that can assist in a more thorough AD-classification	5 years