Probiotics in Mild Alzheimer's Disease

University of Nicosia

Status and phase: Enrolling; Early Phase 1

Conditions: Neurodegenerative Diseases; Cognition Disorders in Old Age

Treatments: Drug: Probiotic Blend Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06181513

AARG-NTF-22-928616

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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

Treatment:

Drug: Probiotic Blend Capsule

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Probiotic Blend Capsule