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Recruiting NCT06181513

Probiotics in Mild Alzheimer's Disease

Early Phase I Interventional Neurodegenerative Diseases Cognition Disorders in Old Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic Blend Capsule.
Who it may be relevant to
Registry conditions: Neurodegenerative Diseases, Cognition Disorders in Old Age. Basic parameters: 65 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Cyprus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

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

  • Drug Probiotic Blend Capsule
    20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)

Primary outcome measures

  • Level of inflammatory markers [Time frame: Baseline (week 0), end of study (week 16)]
Secondary outcome measures (6)
  • Cognitive function and neuropsychological scores [Time frame: Baseline (week 0), end of study (week 16)]
  • Cognitive function and neuropsychological scores [Time frame: Baseline (week 0), end of study (week 16)]
  • Cognitive function and neuropsychological scores [Time frame: Baseline (week 0), end of study (week 16)]
  • Cognitive function and neuropsychological scores [Time frame: Baseline (week 0), end of study (week 16)]
  • Neurophysiological activity changes [Time frame: Baseline (week 0), end of study (week 16)]
  • Microbiome profile [Time frame: Baseline (week 0)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Cyprus · 1 center
  • The Cyprus Institute of Neurology and Genetics — Nicosia

Identifiers

NCT: NCT06181513 · AARG-NTF-22-928616

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗