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Recruiting EARLY_Phase 1 NCT06181513

NCT06181513 Probiotics in Mild Alzheimer's Disease

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Clinical Trial Summary
NCT ID NCT06181513
Status Recruiting
Phase EARLY_Phase 1
Sponsor University of Nicosia
Condition Neurodegenerative Diseases
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2022-12-19
Primary Completion 2025-07-01

Eligibility & Interventions

Sex All sexes
Min Age 65 Years
Max Age 85 Years
Study Type INTERVENTIONAL
Interventions
Probiotic Blend Capsule

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 40 participants in total. It began in 2022-12-19 with a primary completion date of 2025-07-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).

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

Contact & Investigator

Central Contact

Nicoletta Nicolaou

✉ nicolaou.nic@unic.ac.cy

📞 +35722471903

Frequently Asked Questions

Who can join the NCT06181513 clinical trial?

This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Neurodegenerative Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06181513 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT06181513 currently recruiting?

Yes, NCT06181513 is actively recruiting participants. Contact the research team at nicolaou.nic@unic.ac.cy for enrollment information.

Where is the NCT06181513 trial being conducted?

This trial is being conducted at Nicosia, Cyprus.

Who is sponsoring the NCT06181513 clinical trial?

NCT06181513 is sponsored by University of Nicosia. The trial plans to enroll 40 participants.

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