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Recruiting NCT07332260

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

Phase I Interventional Alzheimer s Disease Faecal Microbiota Transplantation (FMT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological: Preprocessed thawed donor FMT.
Who it may be relevant to
Registry conditions: Alzheimer s Disease, Faecal Microbiota Transplantation (FMT). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Alzheimer's Disease and Faecal Microbiota Transplantation

Overview

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

Detailed description

Alzheimer's disease (AD) is the most common cause of dementia.

Studies suggest that the gut flora may play a role in the development and/or progression of AD. The gut flora is found to be different in AD compared to healthy individuals. There is also support for a link between the gut flora and diseases affecting the brain, including AD.

Stool transplantation is an established medical treatment for Clostridioides difficile infections by restoring the balance of the gut flora. In this study, gut flora (a stool solution) is transferred from a healthy individual to an individual with AD. The stool transplantation is given during a colonoscopy examination of the large bowel.

Interventions

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

Primary outcome measures

  • Incidence of treatment-related adverse events and serious adverse events. [Safety] [Time frame: From baseline to 3 months after faecal microbiota transplantation]
  • Rate of participant recruitment [Feasibility] [Time frame: 1 year]
  • Number participants that complete colonoscopy [Feasibility] [Time frame: 1 year]
  • Time used per intervention [Feasibility] [Time frame: 1 year]
  • Number that meet study eligibility [Feasibility] [Time frame: 1 year]
  • Number that complete study [Feasibility] [Time frame: Baseline and 3 months after study intervention]
  • Engraftment of faecal microbiota transplantation (FMT) [Time frame: baseline and 3 months after study intervention]
Secondary outcome measures (9)
  • Cognition: Clinical dementia rating scale - sum of boxes (CDR-SB) [Time frame: Baseline and 3 months after study intervention]
  • Cognition: Montreal Cognitive Assessment (MoCA) [Time frame: Baseline and 3 months after study intervention]
  • Cognition: Trailmaking Test (TMT) [Time frame: Baseline and 3 months after study intervention]
  • Cognition: Wordlist [Time frame: Baseline and 3 months after study intervention]
  • FAS Test of verbal fluency [Time frame: At baseline and after 3 months after study intervention]
  • Cognition: constructional praxis [Time frame: at baseline and 3 months after study intervention]
  • Cognition: neuropsychiatric inventory (NPI) [Time frame: Baseline and 3 months after study intervention]
  • Cognition: Activities of Daily Living (ADL) [Time frame: Baseline and 3 months after study intervention]
  • Changes in Quality of Life [Time frame: Baseline and 3 months after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • University Hospital of North Norway, Tromsø — Tromsø

Identifiers

NCT: NCT07332260 · 853867/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗