Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study

Incidence of adverse events (AE) and serious adverse events (SAE). AE and SAE are evaluated by review of the medical record, questions of AE and SAE in person or by telephone, and AE and SAE forms.

Number of weeks needed to include ten participants for study intervention group

Number of participants that complete colonoscopy

Time given in hours and minutes of total time used for intervention per participant including colonoscopy and faecal microbiota transplantation.

Number of participants who are screened for study eligibility. Number who meet inclusion and exclusion criteria.

Proportion of participants enrolled that complete the study follow-up.

Comparison of the taxonomic composition of the microbiome in participants faecal samples at baseline and 3 months after FMT, with donor faecal sample. Metagenomic sequencing of faecal samples will be used.

Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) is a cognitive test that is used to assess the severity of dementia. It evaluates six cognitive and functional domains, where the scores are summed to provide a total score from 0 to 18. It is useful for tracking disease progression.

Participants will be tested at baseline and 3 months after faecal microbiota transplantation.

Change in the Montreal Cognitive Assessment (MoCA) from baseline and 3 months after intervention. The MoCA is a brief cognitive test used to detect mild cognitive impairment and early stages of dementia. It is scored out of 30 points. A lower score indicates a higher impairment.

Change in Trailmaking Tests (TMT) comparing baseline and 3 month after study intervention. The TMT is a neuropsychological test in two parts where visual attention, visuomotor coordination, processing speed and executive function are tested. The test is performed in two parts (A and B) and the result is reported in seconds used to complete task.

Change in verbal memory assessed by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) comparing baseline and 3 months after study intervention. The CERAD wordlist is a standard test where the participant is asked to recall a list of ten words. Its result is given as number of words correctly recalled, adjusted to normative data. The norwegian version is used.

The FAS test is a rapid verbal fluency test where a person must list as many words as possible starting with the letters F, A, and S within 60 seconds per letter. It evaluates executive functioning, language processing, and frontal lobe function by measuring a person's ability to recall vocabulary under timed constraints

The participant is asked to copy four geometric figures as defined by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) test for Constructional Praxisand recall of constructional praxis, each scored from 0-11 with a low score indicating impairment

Change in neuropsychiatric inventory (NPI) will be assessed comparing baseline with 3 months after study intervention.

The NPI is a questionnaire following interview with a caregiver or informant who is familiar with the participant. Results are given as a number scale from 0-12 across the behavioural and psychological domains commonly affected in dementia. The domain scores are added up to a total NPI score which can range from 0 to 144. A higher NPI score indicates a greater neuropsychiatric symptom burden.

Changes in activities of daily living (ADL) will be assessed comparing baseline and 3 months after study intervention. ADL will be measured by a number score for instrumental and personal activities of living using standardised questionnaires.

ADL is given as a score, a lower score indicates impairment.

Changes in Quality of Life at baseline and 3 months after study intervention will be assessed using the questionnaire EuroQol-5-Dimensions (EQ-5D) which is a standardised test where an individual rates their health-related quality of life based on five dimensions as well as a scale from 0 (worst imaginable health) to 100 (best imaginable health).

Comparison of plasma phosphorylated tau at threonine 217 (p-tau217) levels measured at baseline and 3 months after study intervention will be compared.

P-tau217 is a specific biomarker and a core biomarker for Alzheimer's disease. It is measured in picograms per milliliter.