Alzheimer s DiseasePhase 1AD-FMTNCT07332260
Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study
A Phase 1 study testing Biological: Preprocessed thawed donor FMT in people with Alzheimer s Disease and Faecal Microbiota Transplantation (FMT), run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer s Disease, Faecal Microbiota Transplantation (FMT)
- What is being tested?
- Biological: Preprocessed thawed donor FMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- May 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications for colonoscopy examination
- Contraindications for Magnetic Resonance Imaging (MRI)
- Life expectancy < 1 year
- Clinical frailty scale 7 or more
- History of seizure disorder
- History of brain tumour or intracranial bleed
Show all 17Show fewer
- Major psychiatric disorder such as schizophrenia, bipolar disorder, or major depressive disorder
- Alcohol or substance abuse
- Decompensated heart disease
- Malignancy
- Current use of anticoagulant treatment (dual acting oral anticoagulant or warfarin)
- Pregnant or planning pregnancy
- Colonic adenomas over 1 cm, tumours or signs of active colitis on colonoscopy
- Status after colectomy or hemicolectomy
- Inflammatory bowel disease
- Immunocompromised individual
- Receiving biological/antibody treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University Hospital of North Norway, Tromsø
Tromsø, Troms, 9016
Dr Gundersen, MBChB, +47 77798916, mona.dixon.gundersen@unn.no
About this study
Official title: Alzheimer's Disease and Faecal Microbiota Transplantation
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
Read the detailed description
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.
- Being tested
- Biological: Preprocessed thawed donor FMT
- Keywords
- Alzheimer's disease, Dementia, Gut microbiota, faecal microbiota transplantation, FMT
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: Preprocessed thawed donor FMTBiological
Biological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Faecal microbiota transplantation (FMT) | Experimental | Single-group, single-centre, open-label. Intervention: Faecal microbiota transplantation administered via colonoscopy to the right side of the colon. Receives: Biological: Biological: Preprocessed thawed donor FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Number participants that complete colonoscopy [Feasibility]
Number of participants that complete colonoscopy
Measured: 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.
Measured: 1 year
Number that meet study eligibility [Feasibility]
Number of participants who are screened for study eligibility. Number who meet inclusion and exclusion criteria.
Measured: 1 year
Number that complete study [Feasibility]
Proportion of participants enrolled that complete the study follow-up.
Measured: 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.
Measured: baseline and 3 months after study intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single-centre, non-randomised, open label intervention study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Responsible party
- Sponsor
- Investigators
- Mona Dixon Gundersen, MBChB, PhD, Principal investigator, University Hospital of North Norway, Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332260
- Sponsor's protocol ID
- 853867/2025
- Acronym
- AD-FMT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease and Faecal Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT07332260
- Acronym / sponsor ID
- AD-FMT / 853867/2025
- Keywords
- Alzheimer's disease, Dementia, Gut microbiota, faecal microbiota transplantation, FMT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single-centre, non-randomised, open label intervention study
| Arm | Type | Receives |
|---|---|---|
| Faecal microbiota transplantation (FMT) | Experimental | Biological: Biological: Preprocessed thawed donor FMTSingle-group, single-centre, open-label. Intervention: Faecal microbiota transplantation administered via colonoscopy to the right side of the colon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- Contraindications for colonoscopy examination
- Contraindications for Magnetic Resonance Imaging (MRI)
- Life expectancy < 1 year
- Clinical frailty scale 7 or more
- History of seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: Preprocessed thawed donor FMTBiological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy. | Biological | Faecal microbiota transplantation (FMT) |
Primary outcome
Incidence of treatment-related adverse events and serious adverse events. [Safety]
Time frame: From baseline to 3 months after faecal microbiota transplantation
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]
Time frame: 1 year
Number of weeks needed to include ten participants for study intervention group
Number participants that complete colonoscopy [Feasibility]
Time frame: 1 year
Number of participants that complete colonoscopy
Time used per intervention [Feasibility]
Time frame: 1 year
Time given in hours and minutes of total time used for intervention per participant including colonoscopy and faecal microbiota transplantation.
Number that meet study eligibility [Feasibility]
Time frame: 1 year
Number of participants who are screened for study eligibility. Number who meet inclusion and exclusion criteria.
Number that complete study [Feasibility]
Time frame: Baseline and 3 months after study intervention
Proportion of participants enrolled that complete the study follow-up.
Engraftment of faecal microbiota transplantation (FMT)
Time frame: baseline and 3 months after study intervention
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.
9 secondary outcomes
Cognition: Clinical dementia rating scale - sum of boxes (CDR-SB)
Time frame: Baseline and 3 months after study intervention
Cognition: Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and 3 months after study intervention
Cognition: Trailmaking Test (TMT)
Time frame: Baseline and 3 months after study intervention
Cognition: Wordlist
Time frame: Baseline and 3 months after study intervention
FAS Test of verbal fluency
Time frame: At baseline and after 3 months after study intervention
Cognition: constructional praxis
Time frame: at baseline and 3 months after study intervention
Cognition: neuropsychiatric inventory (NPI)
Time frame: Baseline and 3 months after study intervention
Cognition: Activities of Daily Living (ADL)
Time frame: Baseline and 3 months after study intervention
Changes in Quality of Life
Time frame: Baseline and 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mona Dixon Gundersen, MBChB, PhD principal investigator
University Hospital of North Norway, Tromsø
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological: Preprocessed thawed donor FMT in people with Alzheimer s Disease and Faecal Microbiota Transplantation (FMT), run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Dixon Gundersen, MBChB, PhD (+47 77798916, mona.dixon.gundersen@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events and serious adverse events. [Safety] (time frame: From baseline to 3 months after faecal microbiota transplantation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.