Mild Cognitive ImpairmentMultiADNCT06448403
Multimodal Assesment of Alzheimer Patients
An observational study of Mild Cognitive Impairment and Alzheimer Disease, Late Onset, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Late Onset, Cognitive Impairment
- What is being tested?
- MRI Scanning, 64-channel EEG and Polysomnography
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2024to 29 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The study population is from Tronderlag in Norway, mainly in and around Trondheim city.
Who may be able to join
- MCI and AD according to relevant ICD-criterias.
- Control cohort is age and gender matched with other cohorts.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU)
Trondheim, Trønderlag, 7030
About this study
Official title: Multimodal Assessment of Cognitive Impairment in Alzheimer Patients
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:
- What findings can be used to earlier detect patients that will develop Alzheimers?
- Which differences are seen between healthy and cognitively impaired patients?
- 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.
Read the 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.
- Being tested
- MRI Scanning, 64-channel EEG, Polysomnography, Blood samples, Fecal samples
- Keywords
- Alzheimer Disease (AD), Mild cognitive impairment (MCI), Brain Diseases, Nervous System Disorders, Neurodegenerative Diseases, Dementia, Cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Brain Diseases, Nervous System Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanningDevice
MRI scanning with volumetric, resting and activity-based sequences.
64-channel EEGDevice
EEG to quantifiy electric activity.
PolysomnographyDevice
A randomized group will undergo polysomnography.
Blood samplesBiological
Analysis of specific blood biomarkers.
Fecal samplesBiological
Analysis of bacterial composition.
Cognitive testsBehavioural
Interview-based cognitive tests for assesment of cognitive levels.
| Study group | Role | What they receive |
|---|---|---|
| MCI | Recruitment according to relevant clinical assessment and ICD-criterias. Receives: Device: MRI Scanning; Device: 64-channel EEG; Device: Polysomnography; Biological: Blood samples; Biological: Fecal samples; Behavioral: Cognitive tests | |
| Mild AD | Recruitment according to relevant clinical assessment and ICD-criterias. Receives: Device: MRI Scanning; Device: 64-channel EEG; Device: Polysomnography; Biological: Blood samples; Biological: Fecal samples; Behavioral: Cognitive tests | |
| Control | Equivalent number of research participants as in the MCI and mild AD group. Receives: Device: MRI Scanning; Device: 64-channel EEG; Device: Polysomnography; Biological: Blood samples; Biological: Fecal samples; Behavioral: Cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCI-AD converters
Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.
Measured: 5 years
AD-subclassification
Identify biomarker profiles that can assist in a more thorough AD-classification
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024
- Primary completion29 Dec 2030 (estimated)
- Study completion29 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Sandvig, Prof., MD, PhD, Principal investigator, Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448403
- Sponsor's protocol ID
- 626476
- Acronym
- MultiAD
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No