Studying gut bacteria and brain health in ageing and neurodegenerative disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy young and older adults, and adults with early Alzheimer's disease, Parkinson's disease or relapsing-remitting multiple sclerosis. It studies gut bacteria and the brain.

Age

20 to 90 years. Healthy people: 20-50 or 60-90 years.

Sex

All sexes can join.

Disease stage

Early (prodromal) Alzheimer's disease with Clinical Dementia Rating 0.5 and MMSE above 23. Recently diagnosed Parkinson's disease with a mild-moderate UPDRS score. Recently diagnosed relapsing-remitting multiple sclerosis with Expanded Disability Status Scale score of 4.0 or lower.

Earlier treatment

People taking Parkinson's or multiple sclerosis medicines must be on a stable dose for at least 6 months. People who had antibiotics in the last 3 months cannot join.

Main reasons for not taking part

• Cannot have an MRI scan (metal implant in the body, known claustrophobia, pacemaker)
• Severe other illnesses
• Antibiotic treatment in the last 3 months
• Healthy people with a significant neurological disorder

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 20 and 90 years old?YesNo

What the trial wants to find out

Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear.

The 5 groups in the trial

• Young Healthy Subjects (N = 40)

  * 20-50 years old * Cognitively healthy (Mini-Mental State examination ≥ 26) * Absence of significant neurological disorders

  Treatment: Magnetic Resonance Imaging, Neuropsychological protocol, Eating habits, Microbiome analyses, and Inflammatory markers

• Old Healthy Subjects (N = 40)

  * 60-90 years old * Cognitively healthy (Mini-Mental State examination ≥ 26) * Absence of significant neurological disorders

  Treatment: Magnetic Resonance Imaging, Neuropsychological protocol, Eating habits, Microbiome analyses, and Inflammatory markers

• Patients with prodromal Alzheimer's Disease (N = 40)

  * Subjective cognitive complaint (corroborated by the informant) * Episodic memory deficit on neuropsychological testing * Clinical Dementia Rating = 0.5 * Mini-Mental State Examination (MMSE) \> 23 * Independently functioning in activities of daily living

  Treatment: Magnetic Resonance Imaging, Neuropsychological protocol, Eating habits, Microbiome analyses, Inflammatory markers, and Alzheimer's Disease biomarkers

• Patients with Parkinson's Disease (N = 40)

  * Recent diagnosis of Parkinson's Disease * Mild-moderate score at the Unified Parkinson's Disease Rating Scale (UPDRS) * Cognitively healthy (Mini-Mental State examination ≥ 26) * In case of taking medications for Parkinson's Disease: stable dosage for at least 6 months

  Treatment: Magnetic Resonance Imaging, Neuropsychological protocol, Eating habits, Microbiome analyses, and Inflammatory markers

• Patients with Multiple Sclerosis (N = 40)

  * Recent diagnosis of relapsing-remitting Multiple Sclerosis * Expanded Disability Status Scale score ≤ 4.0 * Cognitively healthy (Mini-Mental State examination ≥ 26) * In case of taking medications for Multiple Sclerosis: stable dosage for at least 6 months

  Treatment: Magnetic Resonance Imaging, Neuropsychological protocol, Eating habits, Microbiome analyses, and Inflammatory markers