NCT06181513

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

December 8, 2023

Last Update Submit

December 3, 2024

Conditions

Neurodegenerative DiseasesCognition Disorders in Old Age

Keywords

probioticsElectroencephalogram (EEG)cognitive functionAlzheimer's Diseaseneuropsychological testingElectrocardiogram (EKG)

Outcome Measures

Primary Outcomes (1)

  • Level of inflammatory markers

    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.

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

Secondary Outcomes (6)

  • Cognitive function and neuropsychological scores

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

  • Cognitive function and neuropsychological scores

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

  • Cognitive function and neuropsychological scores

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

  • Cognitive function and neuropsychological scores

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

  • Neurophysiological activity changes

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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Dietary habits

    Baseline (week 0)

Study Arms (2)

Probiotics

EXPERIMENTAL

Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.

Drug: Probiotic Blend Capsule

Placebo

PLACEBO COMPARATOR

Participants received 1 capsule daily of placebo, administered orally for 16 weeks.

Drug: Probiotic Blend Capsule

Interventions

Probiotic Blend CapsuleDRUG

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

Also known as: Ultrabiotique Equilibre 30 Vitavea
PlaceboProbiotics

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cyprus Institute of Neurology and Genetics

Nicosia, Cyprus

RECRUITING

MeSH Terms

Conditions

Neurodegenerative DiseasesAlzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurocognitive DisordersMental Disorders

Central Study Contacts

Nicoletta Nicolaou

CONTACT

+35722471903nicolaou.nic@unic.ac.cy

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 26, 2023

Study Start

December 19, 2022

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations

CY(1)