Personalized supplements for Alzheimer's patients based on gut microbiota
Design of Personalised SupplemenTs Based on the Gut MicRobiota of Alzheimer Patients Through Network and Artificial Intelligence Analysis
This study is testing if personalized dietary supplements based on gut health can help people with Alzheimer's feel better and slow down the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 2 sites (Majadahonda, Madrid and 1 other locations) |
| Trial ID | NCT06199193 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between gut microbiota and Alzheimer's disease, aiming to develop personalized dietary supplements that could potentially modify disease progression. It consists of three stages: first, characterizing healthy subjects and Alzheimer's patients to identify predictive variables; second, designing a tailored supplement based on these characteristics; and third, conducting a randomized trial to compare the new supplement with a standard nutritional supplement for Alzheimer's patients. The approach leverages artificial intelligence to analyze interactions between various factors influencing the disease.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with prodromal Alzheimer's disease who can provide informed consent and have a caregiver to assist with study requirements.
Not a fit: Patients with significant neurological or psychiatric disorders unrelated to Alzheimer's may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention that may help delay the progression of Alzheimer's disease.
How similar studies have performed: While the relationship between gut microbiota and Alzheimer's is being explored, this specific approach using personalized supplements is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. to be able to give written consent signed jointly by the patient's legal representative following the rules of the clinical research ethics committee
2. minimum educational level (reading and writing)
3. proficiency of the language of the tests applied; adequate visual and auditory acuity, in the opinion of the researcher, to enable him/her to carry out the tests in the study (compensatory glasses and hearing aids are allowed
4. compliance with the diagnostic criteria of prodromal Alzheimer's Disease according to the criteria of the Institute on Aging- Alzheimer's Association \[NIA-AA\]: Global Deterioration Scale GDS≥ 2-3
5. Availability of a person ('caregiver') who has frequent and sufficient contact with the subject, so that he/she can provide precise information on the subject's day-to-day life, and attend the visits that are required by the study
Exclusion Criteria:
1. Suffer or have suffered from neurological (epilepsy, sleep disorders, etc.), psychiatric or any other type of pathology (sensory, hepatic, infectious, etc.) which, in the investigator's opinion, may affect their current cognition and functionality
2. Metabolic/endocrine disorders: Type I diabetes, the rest will not be excluded
3. Chronic or sporadic use of antibiotics, antifungals, antivirals or anti-parasitic agents and chronic use of proton pump inhibitors (omeprazole, etc.). The chronic medication that these patients take due to hypertension, diabetes, etc., should be recorded in the database but should not be a criterion for exclusion
4. Suffer from some type of pathology related to the gastrointestinal system or have undergone gastrointestinal surgery (ulcerative colitis, Crohn's disease, bariatric surgery)
5. Pre-menopause or perimenopause
Control patients: recruited among the relatives and companions of the patients and/or in primary care centers in the region of Murcia. The inclusion criteria for the control group will be the same as for the Alzheimer's group except for the requirements regarding cognitive impairment. The intention is for the control group to be similar in age and sex distribution to the Alzheimer's group.
Where this trial is running
Majadahonda, Madrid and 1 other locations
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (Enrolling_by_invitation)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)
Study contacts
- Principal investigator: Mar Larrosa, PhD — Universidad Complutense de Madrid
- Study coordinator: Mar Larrosa, PhD
- Email: mlarrosa@ucm.es
- Phone: +34913942041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.