The gut microbiome is the collection of trillions of microorganisms and their genetic material colonising the gastrointestinal tract. Dysregulation of the diversity and frequency of these microorganisms is known as gut dysbiosis and has been shown to play a critical role in the development of neurodegenerative conditions.

Groundbreaking research in recent years has begun to uncover the extent of gut dysbiosis in Alzheimer’s disease (AD). The progressive impairment of cognitive function in AD is characterised by the severity of two neuropathological hallmarks: amyloid beta plaques and neurofibrillary tangles. Gut bacteria has been linked to the secretion of toxins and short-chain fatty acids that promote the formation of these hallmarks.

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The hope is to translate these findings into therapeutics that alleviate symptoms of the 55 million people worldwide living with AD or other dementias and prevent this number from growing to the estimated 139 million by 2050, as estimated by Alzheimer’s Disease International. GlobalData’s Clinical Trials database reveals an upwards battle lies ahead as the number of neurodegenerative disease microbiome trials remains in single figures year on year. Additionally, company-sponsored microbiome trials remain low (Figure 1, above), indicating investment is hindering progress in the space.

Regardless, there are a few innovative trials currently proceeding. The Army Medical Center of PLA is assessing the effect of faecal microbiota transplantation on cognitive functions in patients with AD while the University of Wisconsin Madison is assessing probiotic intervention on the function of the gut microbiome in patients with or at high risk of AD. Success in these trials may offer confidence to pharmaceutical companies and increase investment within the field.

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