Probiotics in Mild Alzheimer's Disease

Early Phase 1RecruitingNCT06181513

University of Nicosia40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Neurodegenerative Diseases Cognition Disorders in Old Age

Interventions

Probiotic Blend CapsuleDRUG

20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

The Cyprus Institute of Neurology and Genetics

Nicosia, Cyprus

RECRUITING

Outcomes

Primary Outcomes

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.