Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study (AD-FMT)

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.

Study Overview

• Status: Recruiting
• Conditions: Faecal Microbiota Transplantation (FMT); Alzheimer s Disease
• Intervention / Treatment: Biological: Biological: Preprocessed thawed donor FMT

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mona Dixon Gundersen, MBChB, PhD; Phone Number: +47 77798916; Email: mona.dixon.gundersen@unn.no

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9016
      • Recruiting
      • University Hospital of North Norway, Tromsø
      • Contact: Dr Gundersen, MBChB; Phone Number: +47 77798916; Email: mona.dixon.gundersen@unn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Faecal microbiota transplantation (FMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participant recruitment [Feasibility]	Number of weeks needed to include ten participants for study intervention group	1 year
Number participants that complete colonoscopy [Feasibility]	Number of participants that complete colonoscopy	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.	1 year
Number that meet study eligibility [Feasibility]	Number of participants who are screened for study eligibility. Number who meet inclusion and exclusion criteria.	1 year
Number that complete study [Feasibility]	Proportion of participants enrolled that complete the study follow-up.	Baseline and 3 months after study intervention
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.	From baseline to 3 months after faecal microbiota transplantation
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.	baseline and 3 months after study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	Baseline and 3 months after 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.	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.	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	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	at baseline and 3 months after study intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months after intervention

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: UiT The Arctic University of Norway
• Investigators: Principal Investigator: Mona Dixon Gundersen, MBChB, PhD, University Hospital of North Norway, Tromsø

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Dementia; Gut microbiota; FMT; faecal microbiota transplantation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 853867/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No