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

NCT07332260 | Recruiting Phase 1

• 1 other identifier: 853867/2025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.

Conditions

Alzheimer s Disease; Faecal Microbiota Transplantation (FMT)

Keywords

Alzheimer's disease; Dementia; Gut microbiota; faecal microbiota transplantation; FMT

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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 Outcomes (9)

• Cognition: Clinical dementia rating scale - sum of boxes (CDR-SB)

  Baseline and 3 months after study intervention

• Cognition: Montreal Cognitive Assessment (MoCA)

  Baseline and 3 months after study intervention

• Cognition: Trailmaking Test (TMT)

  Baseline and 3 months after study intervention

• Cognition: Wordlist

  Baseline and 3 months after study intervention

• FAS Test of verbal fluency

  At baseline and after 3 months after study intervention

Other Outcomes (1)

• Changes in biomarkers for Alzheimer's disease

  Baseline and 3 months after intervention

Study Arms (1)

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.

Biological: Biological: Preprocessed thawed donor FMT

Interventions

Biological: Preprocessed thawed donor FMT BIOLOGICAL

Biological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy.

Faecal microbiota transplantation (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• UiT The Arctic University of Norway: collaborator

Study Sites (1)

University Hospital of North Norway, Tromsø

Tromsø, Troms, 9016, Norway

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mona Dixon Gundersen, MBChB, PhD

  University Hospital of North Norway, Tromsø

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Dixon Gundersen, MBChB, PhD

CONTACT

+47 77798916; mona.dixon.gundersen@unn.no

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, single-centre, non-randomised, open label intervention study

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)