Identifying brain connectivity changes in Alzheimer's disease
Clinical Application of a Brain Connectivity Marker for Early Detection of Alzheimer's Disease
This study is trying to see if changes in how different parts of the brain connect can help predict who might develop Alzheimer's disease and how treatments might affect this.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Solna) |
| Trial ID | NCT06874231 on ClinicalTrials.gov |
What this trial studies
This project aims to determine if changes in brain connectivity can predict the development of Alzheimer's disease. The study will involve six specific objectives, including identifying brain connectivity changes in individuals with abnormal AD biomarkers, assessing correlations with synaptic dysfunction and inflammation, and evaluating the impact of treatments like cholinesterase inhibitors and statins. Additionally, it will explore the relationship between brain connectivity and cognitive decline, as well as the presence of microorganisms in cerebrospinal fluid. Neuroimaging techniques will be utilized to gather data.
Who should consider this trial
Good fit: Ideal candidates include individuals with subjective cognitive complaints, mild cognitive impairment, or diagnosed Alzheimer's disease who meet specific cognitive assessment criteria.
Not a fit: Patients with significant cognitive impairment or dementia, as well as those who do not speak or understand Swedish, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early predictive markers for Alzheimer's disease, improving diagnosis and treatment strategies.
How similar studies have performed: Other studies have shown promise in using brain connectivity as a biomarker for Alzheimer's disease, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. 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. 3. 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. 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.
Where this trial is running
Stockholm, Solna
- Karolinska University Hospital — Stockholm, Solna, Sweden (Recruiting)
Study contacts
- Study coordinator: Joana B. Pereira, PhD
- Email: joana.pereira@ki.se
- Phone: +46709966186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.