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NCT Number: NCT06181513

Probiotics in Mild Alzheimer's Disease

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).

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Key information

Conditions

Neurodegenerative Diseases Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders in Old Age Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Tauopathies

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Cyprus Institute of Neurology and Genetics

Nicosia, Cyprus

Location status: Recruiting

Location contact

Ioanna Kousiappa

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Blend Capsule

Drug

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

Other names: Ultrabiotique Equilibre 30 Vitavea

Primary outcomes

  1. Level of inflammatory markers

    Time frame: 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 outcomes

  1. Cognitive function and neuropsychological scores

    Time frame: Baseline (week 0), end of study (week 16)

    Mini-Mental State Examination (MMSE)

  2. Cognitive function and neuropsychological scores

    Time frame: Baseline (week 0), end of study (week 16)

    Montreal Cognitive Assessment (MoCA)

  3. Cognitive function and neuropsychological scores

    Time frame: Baseline (week 0), end of study (week 16)

    Rey-Osterrieth complex figure test

  4. Cognitive function and neuropsychological scores

    Time frame: Baseline (week 0), end of study (week 16)

    Wechsler Abbreviated Scale of Intelligence (WASI)

  5. Neurophysiological activity changes

    Time frame: Baseline (week 0), end of study (week 16)

    Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed).

  6. Microbiome profile

    Time frame: Baseline (week 0)

    16S rDNA gene sequencing for bacterial identification, taxonomic profiling.

Other outcomes

  1. Dietary habits

    Time frame: Baseline (week 0)

    Food Frequency Questionnaire (confounding)

Study contacts

Contact information is provided by the study sponsor or research team.

Nicoletta Nicolaou

CONTACT

[email protected]

+35722471903

Sponsors and collaborators

Lead sponsor

University of Nicosia

Other

Collaborators

  • Cyprus Institute of Neurology and Genetics

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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