Neurodegenerative Diseases, Cognition Disorders in Old Age
Conditions
Keywords
probiotics, Electroencephalogram (EEG), cognitive function, Alzheimer's Disease, neuropsychological testing, Electrocardiogram (EKG)
Brief summary
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).
Detailed description
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.
Interventions
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Sponsors
Cyprus Institute of Neurology and Genetics
University of Nicosia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults ≥65 years, able to give consent * Mini-Mental State Examination (MMSE) scores 19-23 (mild AD) * approximately equal male:female ratio
Exclusion criteria
* Inability to give consent * other neurological disease * relevant psychiatric disorders (e.g. major depression) * gastrointestinal/metabolic conditions * history of alcohol/substance dependence * use of systemic antibiotics in the previous 6 months * corticosteroid use * immune stimulating medications * immunosuppressive agents * probiotics consumption in the previous 6 months. * immunosuppression * structural heart disease * neutropenia * radiation * active intestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of inflammatory markers | Baseline (week 0), end of study (week 16) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function and neuropsychological scores | Baseline (week 0), end of study (week 16) | Mini-Mental State Examination (MMSE) |
| Neurophysiological activity changes | Baseline (week 0), end of study (week 16) | Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed). |
| Microbiome profile | Baseline (week 0) | 16S rDNA gene sequencing for bacterial identification, taxonomic profiling. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary habits | Baseline (week 0) | Food Frequency Questionnaire (confounding) |
Countries
Cyprus
Contacts
Primary ContactNicoletta Nicolaou
Outcome results
None listed