Status:

RECRUITING

Probiotics in Mild Alzheimer's Disease

Lead Sponsor:

University of Nicosia

Collaborating Sponsors:

Cyprus Institute of Neurology and Genetics

Conditions:

Neurodegenerative Diseases

Cognition Disorders in Old Age

Eligibility:

All Genders

65-85 years

Phase:

EARLY_PHASE1

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 neurophysio...

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 a...

Eligibility Criteria

Inclusion

  • Adults ≥65 years, able to give consent
  • Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
  • approximately equal male:female ratio

Exclusion

  • 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

Key Trial Info

Start Date :

December 19 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06181513

Start Date

December 19 2022

End Date

December 1 2025

Last Update

December 5 2024

Active Locations (1)

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1

The Cyprus Institute of Neurology and Genetics

Nicosia, Cyprus