Probiotics in Mild Alzheimer's Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversity of Nicosia
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adults ≥65 years, able to give consent
Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
approximately equal male:female ratio
Disqualifiers
Inability to give consent
other neurological disease
relevant psychiatric disorders (e.g. major depression)
gastrointestinal/metabolic conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic Blend Capsule
Drug20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ProbioticsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (week 0), end of study (week 16)Secondary outcomes
1
Cognitive function and neuropsychological scores
Mini-Mental State Examination (MMSE)
Time frame
Baseline (week 0), end of study (week 16)2
Cognitive function and neuropsychological scores
Montreal Cognitive Assessment (MoCA)
Time frame
Baseline (week 0), end of study (week 16)3
Cognitive function and neuropsychological scores
Rey-Osterrieth complex figure test
Time frame
Baseline (week 0), end of study (week 16)4
Cognitive function and neuropsychological scores
Wechsler Abbreviated Scale of Intelligence (WASI)
Time frame
Baseline (week 0), end of study (week 16)Other outcomes
1
Dietary habits
Food Frequency Questionnaire (confounding)
Time frame
Baseline (week 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nicosia
Lead sponsor
Cyprus Institute of Neurology and Genetics
Collaborator
Source ClinicalTrials.gov