Karolinska University Hospital
Stockholm, Solna, 171 64, Sweden
Location status: Recruiting
NCT Number: NCT06874231
The main purpose of this project is to establish whether changes in brain connectivity can be used to predict the development of Alzheimer's disease (AD).
Interested in participating?
Request Info40 year–85 year
All sexes
Observational
Stockholm, Solna, 171 64, Sweden
Location status: Recruiting
To achieve this aim, the investigators will perform six different studies that have been designed to achieve the following specific objectives:
1.1. Identify changes of brain connectivity in individuals who show abnormal AD amyloid biomarkers in the cerebrospinal fluid and blood.
1.2. To assess the correlation between brain connectivity changes and biomarkers of synaptic dysfunction and inflammation as well as alterations of electrical brain signals.
1.3. Establish whether alterations of brain connectivity could be improved after patients start treatment with cholinesterase inhibitors.
1.4. Assess differences in brain connectivity between patients receiving treatment with statins and those not taking this medication.
1.5. Determine whether brain connectivity changes can predict longitudinal cognitive decline and conversion to AD dementia.
1.6. Assess whether different microorganisms can grow more rapidly in the cerebrospinal fluid from AD patients compared to controls and whether their levels are associated with brain connectivity.
1.7. Evaluate the relationship between brain connectivity and the integrity of the locus coeruleus, which is the earliest site of AD pathology
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In addition, participants who have claustrophobia or some form of metal implant in their body that may interfere with the brain imaging scan will be excluded from the study.
The investigators will collect imaging sequence, cognitive test scores, clinical data and biofluid samples
Other names: Cognitive assessment
Time frame: 4 years
The investigators will build a multilayer network for each patient using DWI and fMRI images, following a methodology similar to that described in Multiplex Connectome Changes Across the Alzheimer's Disease Spectrum Using Gray Matter and Amyloid Data. Specifically, each patient's brain connectivity will be modeled as a multiplex network, where distinct imaging modalities define different layers. The structural connectivity layer will be derived from diffusion-weighted imaging (DWI), capturing white matter fiber tract connections between brain regions. The functional connectivity layer will be built using functional MRI (fMRI), measuring temporal correlations of neural activity across regions. Nodes in the network will correspond to anatomically defined brain regions, and inter-layer edges will be established to link homologous regions across layers, enabling integration of structural and functional information.
Time frame: 4 years
The investigators will measure the association between multilayer brain connectivity with biomarkers and clinical measures from the participants, including markers of amyloid, tau, vascular pathology and tests measuring memory, executive function, language and visuospatial skills. These analyses will be conducted using linear regression and linear mixed effects models for longitudinal outcomes.
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Clinical Application of a Brain Connectivity Marker for Early Detection of Alzheimer's Disease
Acronym: BRAINCONN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06014424
Alzheimer Disease, Brain Diseases
Calgary, Alberta, Canada
View Trial DetailsNCT06847321
Alzheimer Disease, Alzheimer Disease Due to P. Gingivalis
Phoenix, Arizona, United States
View Trial DetailsNCT06937229
Aberrant Motor Behavior in Dementia, Agitation
Chandler, Arizona, United States
View Trial DetailsNCT06862960
Alzheimer Disease, Brain Diseases
Fuzhou, Fujian, China
View Trial Details