Probiotics in Mild Alzheimer's Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease

Conditions
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Neurodegenerative Diseases, Cognition Disorders in Old Age

Intervention / Treatment
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* Drug: Probiotic Blend Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Participants received 1 capsule daily of probiotics, administered orally for 16 weeks. | Drug: Probiotic Blend Capsule<br>* 20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)<br>* Other names: Ultrabiotique Equilibre 30 Vitavea;|
| Placebo Comparator: Placebo<br>Participants received 1 capsule daily of placebo, administered orally for 16 weeks. | Drug: Probiotic Blend Capsule<br>* 20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)<br>* Other names: Ultrabiotique Equilibre 30 Vitavea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, Electroencephalogram (EEG), cognitive function, Alzheimer's Disease, neuropsychological testing, Electrocardiogram (EKG)