NCT06448403

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:

  • Cognitive tests
  • Magnetic resonance imaging (MRI)
  • Electroencephalography (EEG)
  • Blood sample collection
  • Fecal sample collection
  • A randomized group will undergo polysomnography analysis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
55mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jul 2024Dec 2030

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2030

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

6.5 years

First QC Date

June 3, 2024

Last Update Submit

August 4, 2025

Conditions

Mild Cognitive ImpairmentAlzheimer Disease, Late OnsetCognitive ImpairmentDementia

Keywords

Alzheimer Disease (AD)Mild cognitive impairment (MCI)Brain DiseasesNervous System DisordersNeurodegenerative DiseasesDementiaCognitive impairment

Outcome Measures

Primary Outcomes (2)

  • MCI-AD converters

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

    5 years

  • AD-subclassification

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

    5 years

Study Arms (3)

MCI

Recruitment according to relevant clinical assessment and ICD-criterias.

Device: MRI ScanningDevice: 64-channel EEGDevice: PolysomnographyBiological: Blood samplesBiological: Fecal samplesBehavioral: Cognitive tests

Mild AD

Recruitment according to relevant clinical assessment and ICD-criterias.

Device: MRI ScanningDevice: 64-channel EEGDevice: PolysomnographyBiological: Blood samplesBiological: Fecal samplesBehavioral: Cognitive tests

Control

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

Device: MRI ScanningDevice: 64-channel EEGDevice: PolysomnographyBiological: Blood samplesBiological: Fecal samplesBehavioral: Cognitive tests

Interventions

MRI ScanningDEVICE

MRI scanning with volumetric, resting and activity-based sequences.

ControlMCIMild AD
64-channel EEGDEVICE

EEG to quantifiy electric activity.

ControlMCIMild AD
PolysomnographyDEVICE

A randomized group will undergo polysomnography.

ControlMCIMild AD
Blood samplesBIOLOGICAL

Analysis of specific blood biomarkers.

ControlMCIMild AD
Fecal samplesBIOLOGICAL

Analysis of bacterial composition.

ControlMCIMild AD
Cognitive testsBEHAVIORAL

Interview-based cognitive tests for assesment of cognitive levels.

ControlMCIMild AD

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • MCI and AD according to relevant ICD-criterias.
  • Control cohort is age and gender matched with other cohorts.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU)

Trondheim, Trønderlag, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseDementiaBrain DiseasesNervous System DiseasesNeurodegenerative Diseases

Interventions

PolysomnographyBlood Specimen CollectionNeuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersCentral Nervous System DiseasesTauopathies

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Axel Sandvig, Prof., MD, PhD

    Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Sandvig, Prof., MD, PhD

CONTACT

72 57 56 20axel.sandvig@ntnu.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 29, 2030

Study Completion (Estimated)

December 29, 2030

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations

NO(1)