Probiotics in Mild Alzheimer's Disease

Early Phase 1

Recruiting

• Conditions: Neurodegenerative Diseases; Cognition Disorders in Old Age
• Interventions: Drug: Probiotic Blend Capsule

• Registration Number: NCT06181513
• Lead Sponsor: University of Nicosia

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.

Study Timeline

• Study Start: 2022-12-19
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2023-12-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotic Blend Capsule	Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.
Placebo	Probiotic Blend Capsule	Participants received 1 capsule daily of placebo, administered orally for 16 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cognitive function and neuropsychological scores	Baseline (week 0), end of study (week 16)	Wechsler Abbreviated Scale of Intelligence (WASI)
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.

Trial Locations

Locations (1)

The Cyprus Institute of Neurology and Genetics; 🇨🇾 Nicosia, Cyprus