Alzheimer DiseaseBRAINCONNNCT06874231
Brain Connectivity Marker for Alzheimer's Disease
An observational study of Alzheimer Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Neuroimaging
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects across the AD continuum
Who may be able to join
- Inclusion criteria for subjects with subjective cognitive complaints:
- 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.
Show all 18Show fewer
- Inclusion criteria for patients with mild cognitive impairment:
- 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.
- Specific inclusion criteria for patients with 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Solna, 171 64
Simona Sacuiu, MD, PhD, 0734352012, simona.sacuiu@regionstockholm.se
About this study
Official title: Clinical Application of a Brain Connectivity Marker for Early Detection of Alzheimer's Disease
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).
Read the detailed description
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
- Conditions
- Alzheimer Disease
- Being tested
- Neuroimaging
- Keywords
- MRI, Cognition, MEG/EEG, Biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroimagingOther
Also called Cognitive assessment
The investigators will collect imaging sequence, cognitive test scores, clinical data and biofluid samples
| Study group | Role | What they receive |
|---|---|---|
| SCI normal | Subjects with subjective cognitive impairment with normal amyloid levels. Receives: Other: Neuroimaging | |
| SCI abnormal | Subjects with subjective cognitive impairment with low amyloid levels. Receives: Other: Neuroimaging | |
| MCI abnormal | Subjects with mild cognitive impairment with low amyloid levels. Receives: Other: Neuroimaging | |
| AD abnormal | Subjects with Alzheimer's disease with low amyloid levels. Receives: Other: Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Relationship between multilayer connectivity and other imaging sequences, cognition and biofluid biomarkers
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Apr 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Joana Braga Pereira, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874231
- Sponsor's protocol ID
- Dnr 2023-00026-02
- Acronym
- BRAINCONN
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Brain Connectivity Marker for Early Detection of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06874231
- Acronym / sponsor ID
- BRAINCONN / Dnr 2023-00026-02
- Conditions
- Alzheimer Disease
- Keywords
- MRI, Cognition, MEG/EEG, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCI normal | – | Other: NeuroimagingSubjects with subjective cognitive impairment with normal amyloid levels. |
| SCI abnormal | – | Other: NeuroimagingSubjects with subjective cognitive impairment with low amyloid levels. |
| MCI abnormal | – | Other: NeuroimagingSubjects with mild cognitive impairment with low amyloid levels. |
| AD abnormal | – | Other: NeuroimagingSubjects with Alzheimer's disease with low amyloid levels. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects across the AD continuum
Key inclusion criteria (18 listed)
- Inclusion criteria for subjects with subjective cognitive complaints:
- Inclusion criteria for patients with mild cognitive impairment:
- Specific inclusion criteria for patients with Alzheimer's disease:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroimagingAlso: Cognitive assessmentThe investigators will collect imaging sequence, cognitive test scores, clinical data and biofluid samples | Other | AD abnormal, MCI abnormal, SCI abnormal, SCI normal |
Primary outcome
Brain connectivity can predict the development of Alzheimer's disease
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.
1 secondary outcome
Relationship between multilayer connectivity and other imaging sequences, cognition and biofluid biomarkers
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joana B. Pereira, PhD (+46709966186, joana.pereira@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain connectivity can predict the development of Alzheimer's disease (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.