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

RecruitingPhase 1

Sponsor: University Hospital of North Norway

Conditions: Alzheimer s Disease, Faecal Microbiota Transplantation (FMT)

Interventions: Biological: Preprocessed thawed donor FMT

Countries: Norway

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Tromsø, Troms, Norway