A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease

Launched by JINING MEDICAL UNIVERSITY · Feb 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how the bacteria in our gut might affect brain health, particularly in people with Alzheimer's disease (AD). Researchers believe that certain substances produced by gut bacteria, called short-chain fatty acids (SCFAs), could play a role in connecting our gut health to brain health. The study will look at different groups of people, including those who are cognitively normal, those experiencing early signs of memory decline, those with mild cognitive impairment, and those diagnosed with AD dementia. By examining the differences in gut bacteria and SCFAs, as well as using advanced brain imaging techniques, the researchers hope to uncover how these factors interact over time.

To participate, you may be eligible if you are between 21 and 92 years old and fall into one of the groups mentioned above. For instance, if you are cognitively normal with no memory complaints, or if you have noticed a decline in your memory but are still performing well on cognitive tests, you might qualify. Participants will undergo various tests and assessments over the course of five years, helping researchers build a clearer picture of the relationship between gut health and brain function. It’s important to note that certain health conditions or recent treatments may exclude someone from joining the study. If you're interested, this trial could contribute to understanding Alzheimer's disease better and potentially improving diagnosis and treatment in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Cognitively normal group:
• • 1. normal performance on standardized cognitive tests;
• • 2. with no cognitive complaints or any concerns (worries).
• * SCD group:
• • 1. self-experienced persistent decline in memory, rather than other domains of cognition;
• • 2. normal performance on standardized cognitive tests;
• • 3. failure to meet the criteria for MCI or dementia;
• • 4. age at onset of SCD ≥ 60 years old;
• • 5. onset of SCD within the last 5 years;
• • 6. concerns (worries) associated with SCD;
• • 7. feeling of worse performance than others of the same age group.
• * MCI group:
• • 1. having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function);
• • 2. having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function);
• • 3. the Functional Activities Questionnaire (FAQ)≥9.
• * AD dementia group:
• • 1. meet the criteria for dementia and have impaired daily functional activities;
• • 2. episodic memory deficit; 3) Clinical Dementia Rating (CDR) ≥ 1.
• Exclusion Criteria:
• • a history of stroke;
• • major depression and anxiety;
• • other central nervous system disorders that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis, and epilepsy;
• • cognitive impairment caused by traumatic brain injury;
• • systemic diseases, such as thyroid dysfunction, syphilis and HIV;
• • psychosis or congenital mental developmental delay;
• • a history of using antibiotics, probiotics, prebiotics, or synbiotics within 3 months;
• • the use of corticosteroid, immune stimulating medications, and immunosuppressive agents;
• • major gastrointestinal tract surgery in past 5 years;
• • severe gastrointestinal diseases, such as irritable bowel syndrome, infammatory bowel disease, severe gastritis, other dysfunction in digestion and absorption, which has been reported to infuence gut microbiota