About this trial
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Alzheimer's dementia mild to moderate stage
Presence of Alzheimer pathology core 1 biomarkers as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (2024)
Capable of giving informed consent
Disqualifiers
Contraindications for colonoscopy examination
Contraindications for Magnetic Resonance Imaging (MRI)
Life expectancy < 1 year
Clinical frailty scale 7 or more
Trial design
Single group
Treatments tested in this trial
Biological: Preprocessed thawed donor FMT
Biological/VaccineBiological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of treatment-related adverse events and serious adverse events. [Safety]
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.
Rate of participant recruitment [Feasibility]
Number of weeks needed to include ten participants for study intervention group
Number participants that complete colonoscopy [Feasibility]
Number of participants that complete colonoscopy
Time used per intervention [Feasibility]
Time given in hours and minutes of total time used for intervention per participant including colonoscopy and faecal microbiota transplantation.
Secondary outcomes
Cognition: Clinical dementia rating scale - sum of boxes (CDR-SB)
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.
Cognition: Montreal Cognitive Assessment (MoCA)
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.
Cognition: Trailmaking Test (TMT)
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.
Cognition: Wordlist
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.
Other outcomes
Changes in biomarkers for Alzheimer's disease
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.
Sponsors and contacts
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University Hospital of North Norway
Lead sponsor
UiT The Arctic University of Norway
Collaborator