Probiotics in Mild Alzheimer's Disease

Neurodegenerative Diseases Clinical Trial

Official title:

Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181513
• Other study ID #: AARG-NTF-22-928616
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 19, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: University of Nicosia
• Contact: Nicoletta Nicolaou
• Phone: +35722471903
• Email: nicolaou.nic[@]unic.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognition Disorders in Old Age
• Neurodegenerative Diseases

Intervention

Drug:
• Probiotic Blend Capsule
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)

Locations

Country	Name	City	State
Cyprus	The Cyprus Institute of Neurology and Genetics	Nicosia

Sponsors (2)

Lead Sponsor	Collaborator
University of Nicosia	Cyprus Institute of Neurology and Genetics

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary habits	Food Frequency Questionnaire (confounding)	Baseline (week 0)
Primary	Level of inflammatory markers	Peripheral inflammation markers implicated in the pathogenesis of mild-AD (pro-inflammatory cytokines: IL-6, IL-1ß, CXCL2, NLRP3; anti-inflammatory cytokines: IL-10. Isolated from blood plasma.	Baseline (week 0), end of study (week 16)
Secondary	Cognitive function and neuropsychological scores	Mini-Mental State Examination (MMSE)	Baseline (week 0), end of study (week 16)
Secondary	Cognitive function and neuropsychological scores	Montreal Cognitive Assessment (MoCA)	Baseline (week 0), end of study (week 16)
Secondary	Cognitive function and neuropsychological scores	Rey-Osterrieth complex figure test	Baseline (week 0), end of study (week 16)
Secondary	Cognitive function and neuropsychological scores	Wechsler Abbreviated Scale of Intelligence (WASI)	Baseline (week 0), end of study (week 16)
Secondary	Neurophysiological activity changes	Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed).	Baseline (week 0), end of study (week 16)
Secondary	Microbiome profile	16S rDNA gene sequencing for bacterial identification, taxonomic profiling.	Baseline (week 0)