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| Name | Class |
|---|---|
| Cyprus Institute of Neurology and Genetics | OTHER |
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The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).
We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Participants received 1 capsule daily of probiotics, administered orally for 16 weeks. |
|
| Placebo | Placebo Comparator | Participants received 1 capsule daily of placebo, administered orally for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Blend Capsule | Drug | 20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of inflammatory markers | Peripheral inflammation markers implicated in the pathogenesis of mild-AD (pro-inflammatory cytokines: IL-6, IL-1β, CXCL2, NLRP3; anti-inflammatory cytokines: IL-10. Isolated from blood plasma. | Baseline (week 0), end of study (week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function and neuropsychological scores | Mini-Mental State Examination (MMSE) | Baseline (week 0), end of study (week 16) |
| Cognitive function and neuropsychological scores | Montreal Cognitive Assessment (MoCA) |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary habits | Food Frequency Questionnaire (confounding) | Baseline (week 0) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicoletta Nicolaou | Contact | +35722471903 | nicolaou.nic@unic.ac.cy |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cyprus Institute of Neurology and Genetics | Recruiting | Nicosia | Cyprus |
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| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline (week 0), end of study (week 16) |
| Cognitive function and neuropsychological scores | Rey-Osterrieth complex figure test | Baseline (week 0), end of study (week 16) |
| Cognitive function and neuropsychological scores | Wechsler Abbreviated Scale of Intelligence (WASI) | Baseline (week 0), end of study (week 16) |
| Neurophysiological activity changes | Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed). | Baseline (week 0), end of study (week 16) |
| Microbiome profile | 16S rDNA gene sequencing for bacterial identification, taxonomic profiling. | Baseline (week 0) |
| D024801 |
| Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |