Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study
Recruiting · NCT07332260 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital of North Norway
View the official record on ClinicalTrials.gov →Interventions studied
Biological: Preprocessed thawed donor FMT
What this trial is about
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital of North Norway, Tromsø - Tromsø, Troms, Norway