RecruitingPhase 1NCT07332260

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

Alzheimer's Disease and Faecal Microbiota Transplantation


Sponsor

University Hospital of North Norway

Enrollment

10 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria17

  • 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

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Interventions

BIOLOGICALBiological: Preprocessed thawed donor FMT

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


Locations(1)

University Hospital of North Norway, Tromsø

Tromsø, Troms, Norway

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NCT07332260


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