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

RECRUITINGPhase 1Sponsored by University Hospital of North Norway
Actively Recruiting
PhasePhase 1
SponsorUniversity Hospital of North Norway
Started2026-05
Est. completion2026-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07332260

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Alzheimer's DiseaseFaecal Microbiota Transplantation (FMT)

Interventions1

Biological: Preprocessed thawed donor FMT

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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