Cognitive Impairment / Alzheimer Disease, Late Onset / 64-channel EEG · Observational Study

Multimodal Assesment of Alzheimer Patients

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective observational study registered to assess multimodal biomarkers (MRI, EEG, blood, fecal samples, cognitive tests) in patients with mild cognitive impairment and Alzheimer disease over 5 years. The study is actively recruiting and has not yet reported results; it is in the planning phase and cannot yet inform clinical practice.

What was studied

Observational. Mild Cognitive Impairment, Alzheimer Disease, Late Onset, Cognitive Impairment, Dementia; age from 65 Years; accepts healthy volunteers. Intervention: MCI; Mild AD; Control. n = 60. 1 site: Norway.

Key findings

Safety

Study design and outcome measures are specified but no efficacy, safety, or biomarker findings are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting observational registry study with no posted results; it is a study plan rather than evidence of efficacy or safety.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: MCI-AD converters (assessed at 5 years); AD-subclassification (assessed at 5 years)

DesignObservational

PopulationMild Cognitive Impairment, Alzheimer Disease, Late Onset, Cognitive Impairment, Dementia; age from 65 Years; accepts healthy volunteers

Sample size60

InterventionMCI; Mild AD; Control

Setting1 site: Norway

Reported figures

Quoted from the source exactly as published.

Planned enrollment60

Primary outcome measure 1MCI-AD converters at 5 years

Primary outcome measure 2AD-subclassification at 5 years

Study typeObservational

Caveats

No results have been posted in this registry record; study is recruiting and follow-up extends to 5 years.
Study design and outcome measures are specified but no efficacy, safety, or biomarker findings are reported.
No information on comparator groups, blinding, or statistical analysis plan.
Sample size is estimated at only 60 participants, which may limit statistical power for subgroup analyses.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational, non-randomized design; no control group structure specified.

Directness

moderate

Addresses early detection and AD subclassification via multimodal biomarkers.

Consistency

insufficient

No results posted; consistency cannot be assessed from registry record.

Risk of bias

insufficient

Study is recruiting; no methods detail on blinding, allocation, or follow-up.

Sample adequacy

limited

Planned enrollment 60 participants, estimated; modest for long-term prospective biomarker work.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06448403). This is a study registration, not published results. Lead sponsor: Norwegian University of Science and Technology. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Mild Cognitive Impairment, Alzheimer Disease, Late Onset, Cognitive Impairment, Dementia. Interventions: DEVICE: MRI Scanning; DEVICE: 64-channel EEG; DEVICE: Polysomnography; BIOLOGICAL: Blood samples; BIOLOGICAL: Fecal samples; BEHAVIORAL: Cognitive tests. Primary outcome measures: MCI-AD converters , 5 years; AD-subclassification , 5 years. 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: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Cognitive ImpairmentAlzheimer Disease, Late Onset64-channel EEGNorwegian University of Science and TechnologyNCT06448403Mild Cognitive ImpairmentMRI ScanningBlood samplesPolysomnography