Probiotics in Mild Alzheimer's Disease

Last updated: December 3, 2024
Sponsor: University of Nicosia
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Sclerosis

Neurologic Disorders

Treatment

Probiotic Blend Capsule

Clinical Study ID

NCT06181513
AARG-NTF-22-928616
  • Ages 65-85
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Probiotic Blend Capsule
Phase: 1
Study Start date:
December 19, 2022
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • The Cyprus Institute of Neurology and Genetics

    Nicosia,
    Cyprus

    Active - Recruiting

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