Brain Connectivity Marker for Alzheimer's Disease

NCT06874231 | Recruiting

• 1 other identifier: Dnr 2023-00026-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alzheimer Disease

Keywords

MRI; Cognition; MEG/EEG; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Brain connectivity can predict the development of Alzheimer's disease

  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.

  4 years

Secondary Outcomes (1)

• Relationship between multilayer connectivity and other imaging sequences, cognition and biofluid biomarkers

  4 years

Study Arms (4)

SCI normal

Subjects with subjective cognitive impairment with normal amyloid levels.

Other: Neuroimaging

SCI abnormal

Subjects with subjective cognitive impairment with low amyloid levels.

Other: Neuroimaging

MCI abnormal

Subjects with mild cognitive impairment with low amyloid levels.

Other: Neuroimaging

AD abnormal

Subjects with Alzheimer's disease with low amyloid levels.

Other: Neuroimaging

Interventions

Neuroimaging OTHER

The investigators will collect imaging sequence, cognitive test scores, clinical data and biofluid samples

Also known as: Cognitive assessment

AD abnormal; MCI abnormal; SCI abnormal; SCI normal

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects across the AD continuum

You may qualify if:

• MMSE (Mini-mental test) or MoCA (Montreal Cognitive Assessment) points between 26 and 30.
• Absence of cognitive impairment.
• Memory problems reported by the participant/family member.
• Do not fulfill criteria for mild cognitive impairment or dementia.
• Must speak and understand Swedish.
• MMSE (Mini-mental test) or MoCA (Montreal Cognitive Assessment) points between 24 and 30.
• Impaired memory function.
• Do not fulfill criteria for dementia.
• Must speak and understand Swedish.
• Must have abnormal cerebrospinal fluid amyloid-β 42/40 ratio levels, which is a biomarker of Alzheimer's disease.
• MMSE (Mini-mental test) or MoCA (Montreal Cognitive Assessment) points between 18 and 28.
• Impaired memory function in addition to impaired executive abilities, language function, visuospatial ability and/or attention/psychomotor speed.
• Meet NINCDS-ADRDA and DSM-IV criteria for probable Alzheimer's disease.
• Must speak and understand Swedish.
• Must have abnormal spinal fluid amyloid-β 42/40 ratio levels, which is a biomarker of Alzheimer's disease.

You may not qualify if:

• Alcohol or drug abuse.
• Unstable somatic disease or organ failure.
• Refuse to cerebrospinal fluid testing and/or blood sampling, neuropsychological testing, brain imaging, electroencephalogram or magnetoencephalogram.
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Solna, 171 64, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid and blood plasma.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuroimaging; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Joana B. Pereira, PhD

CONTACT

+46709966186; joana.pereira@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: March 13, 2025
• Study Start: April 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 17, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)