Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- University of Nicosia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Level of inflammatory markers
Study Overview
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).
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 and placebo group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Probiotics
Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.
Intervention: Probiotic Blend Capsule (Drug)
Placebo
Participants received 1 capsule daily of placebo, administered orally for 16 weeks.
Intervention: Probiotic Blend Capsule (Drug)
Outcomes
Primary Outcomes
Level of inflammatory markers
Time Frame: Baseline (week 0), end of study (week 16)
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.
Secondary Outcomes
- Cognitive function and neuropsychological scores(Baseline (week 0), end of study (week 16))
- Neurophysiological activity changes(Baseline (week 0), end of study (week 16))
- Microbiome profile(Baseline (week 0))
Investigators
Nicoletta Nicolaou
Associate Professor
University of Nicosia