Brain Connectivity Marker for Alzheimer's Disease

NCT ID: NCT06874231

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2027-07-31

Brief Summary

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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

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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

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SCI normal

Subjects with subjective cognitive impairment with normal amyloid levels.

Neuroimaging

Intervention Type OTHER

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

SCI abnormal

Subjects with subjective cognitive impairment with low amyloid levels.

Neuroimaging

Intervention Type OTHER

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

MCI abnormal

Subjects with mild cognitive impairment with low amyloid levels.

Neuroimaging

Intervention Type OTHER

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

AD abnormal

Subjects with Alzheimer's disease with low amyloid levels.

Neuroimaging

Intervention Type OTHER

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

Interventions

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Neuroimaging

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

Intervention Type OTHER

Other Intervention Names

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Cognitive assessment

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Joana Braga Pereira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, Solna, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Joana B. Pereira, PhD

Role: CONTACT

+46709966186

Facility Contacts

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Simona Sacuiu, MD, PhD

Role: primary

0734352012

Other Identifiers

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Dnr 2023-00026-02

Identifier Type: -

Identifier Source: org_study_id

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