Status:
RECRUITING
Design of Personalised SupplemenTs Based on the Gut MicRobiota Through Artificial Intelligence for Alzheimer's Patients
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Hospital Universitario Virgen de la Arrixaca
Universidad Europea de Madrid
Conditions:
Alzheimer Disease
Gut Microbiota
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
Studies indicate that the intestinal microbiota could have an implication in Alzheimer's disease; recently, a positive relationship has been established between levels of bacterial lipopolysaccharide ...
Detailed Description
The study consists of three main stages, a first part in which healthy subjects and patients will be characterized. With all the variables obtained, network analyzes and predictive analyzes are carrie...
Eligibility Criteria
Inclusion
- to be able to give written consent signed jointly by the patient's legal representative following the rules of the clinical research ethics committee
- minimum educational level (reading and writing)
- 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
- 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
- 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
- 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
- Metabolic/endocrine disorders: Type I diabetes, the rest will not be excluded
- 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
- Suffer from some type of pathology related to the gastrointestinal system or have undergone gastrointestinal surgery (ulcerative colitis, Crohn's disease, bariatric surgery)
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06199193
Start Date
February 1 2024
End Date
December 31 2025
Last Update
December 9 2024
Active Locations (2)
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1
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
2
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain, 30120