A Phase 1 interventional study of Biological: Preprocessed thawed donor FMT in Alzheimer s Disease and Faecal Microbiota Transplantation (FMT), sponsored by University Hospital of North Norway. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University Hospital of North Norway · Phase 1, Interventional, and Treatment
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
Alzheimer's disease (AD) is the most common cause of dementia.
Studies suggest that the gut flora may play a role in the development and/or progression of AD. The gut flora is found to be different in AD compared to healthy individuals. There is also support for a link between the gut flora and diseases affecting the brain, including AD.
Stool transplantation is an established medical treatment for Clostridioides difficile infections by restoring the balance of the gut flora. In this study, gut flora (a stool solution) is transferred from a healthy individual to an individual with AD. The stool transplantation is given during a colonoscopy examination of the large bowel.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-group, single-centre, open-label. Intervention: Faecal microbiota transplantation administered via colonoscopy to the right side of the colon.
Biological: Biological: Preprocessed thawed donor FMT
Biological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy.
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.
Time frame: From baseline to 3 months after faecal microbiota transplantation
Rate of participant recruitment [Feasibility]
Number of weeks needed to include ten participants for study intervention group
Time frame: 1 year
Number participants that complete colonoscopy [Feasibility]
Number of participants that complete colonoscopy
Time frame: 1 year
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.
Time frame: 1 year
Number that meet study eligibility [Feasibility]
Number of participants who are screened for study eligibility. Number who meet inclusion and exclusion criteria.
Time frame: 1 year
Number that complete study [Feasibility]
Proportion of participants enrolled that complete the study follow-up.
Time frame: Baseline and 3 months after study intervention
Engraftment of faecal microbiota transplantation (FMT)
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.
Time frame: baseline and 3 months after study intervention
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.
Time frame: Baseline and 3 months after study intervention
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.
Time frame: Baseline and 3 months after study intervention
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.
Time frame: Baseline and 3 months after study intervention
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.
Time frame: Baseline and 3 months after study intervention
FAS Test of verbal fluency
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
Time frame: At baseline and after 3 months after study intervention
Cognition: constructional praxis
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
Time frame: at baseline and 3 months after study intervention
Cognition: neuropsychiatric inventory (NPI)
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.
Time frame: Baseline and 3 months after study intervention
Cognition: Activities of Daily Living (ADL)
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.
Time frame: Baseline and 3 months after study intervention
Changes in Quality of Life
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).
Time frame: Baseline and 3 months after intervention
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.
Time frame: Baseline and 3 months after intervention
Plan to share: No
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