Study Results
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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RECRUITING
120 participants
OBSERVATIONAL
2023-04-01
2027-07-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SCI normal
Subjects with subjective cognitive impairment with normal amyloid levels.
Neuroimaging
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
Yes
Sponsors
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The Swedish Research Council
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Joana Braga Pereira
Principal Investigator
Locations
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Karolinska University Hospital
Stockholm, Solna, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dnr 2023-00026-02
Identifier Type: -
Identifier Source: org_study_id
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