RecruitingEarly Phase 1

Probiotics in Mild Alzheimer's Disease

Cyprus40 participantsStarted 2022-12-19

Plain-language 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).

Who can participate

Age range65 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Level of inflammatory markers

Timeframe: Baseline (week 0), end of study (week 16)

Trial details

NCT IDNCT06181513

SponsorUniversity of Nicosia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

Contact for this trial

Nicoletta Nicolaou

+35722471903 nicolaou.nic@unic.ac.cy

View on ClinicalTrials.gov More Neurodegenerative Diseases trials