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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindications for colonoscopy examination

Contraindications for Magnetic Resonance Imaging (MRI)

Life expectancy < 1 year

Clinical frailty scale 7 or more

Trial design

Design model

Single group

Treatments tested in this trial

  • Biological: Preprocessed thawed donor FMT

    Biological/Vaccine

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Faecal microbiota transplantation (FMT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-related adverse events and serious adverse events. [Safety]

Incidence of adverse events (AE) and serious adverse events (SAE). AE and SAE are evaluated by review of the medical record, questions of AE and SAE in person or by telephone, and AE and SAE forms.

Time frame
From baseline to 3 months after faecal microbiota transplantation
2

Rate of participant recruitment [Feasibility]

Number of weeks needed to include ten participants for study intervention group

Time frame
1 year
3

Number participants that complete colonoscopy [Feasibility]

Number of participants that complete colonoscopy

Time frame
1 year
4

Time used per intervention [Feasibility]

Time given in hours and minutes of total time used for intervention per participant including colonoscopy and faecal microbiota transplantation.

Time frame
1 year

Secondary outcomes

1

Cognition: Clinical dementia rating scale - sum of boxes (CDR-SB)

Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) is a cognitive test that is used to assess the severity of dementia. It evaluates six cognitive and functional domains, where the scores are summed to provide a total score from 0 to 18. It is useful for tracking disease progression. Participants will be tested at baseline and 3 months after faecal microbiota transplantation.

Time frame
Baseline and 3 months after study intervention
2

Cognition: Montreal Cognitive Assessment (MoCA)

Change in the Montreal Cognitive Assessment (MoCA) from baseline and 3 months after intervention. The MoCA is a brief cognitive test used to detect mild cognitive impairment and early stages of dementia. It is scored out of 30 points. A lower score indicates a higher impairment.

Time frame
Baseline and 3 months after study intervention
3

Cognition: Trailmaking Test (TMT)

Change in Trailmaking Tests (TMT) comparing baseline and 3 month after study intervention. The TMT is a neuropsychological test in two parts where visual attention, visuomotor coordination, processing speed and executive function are tested. The test is performed in two parts (A and B) and the result is reported in seconds used to complete task.

Time frame
Baseline and 3 months after study intervention
4

Cognition: Wordlist

Change in verbal memory assessed by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) comparing baseline and 3 months after study intervention. The CERAD wordlist is a standard test where the participant is asked to recall a list of ten words. Its result is given as number of words correctly recalled, adjusted to normative data. The norwegian version is used.

Time frame
Baseline and 3 months after study intervention

Other outcomes

1

Changes in biomarkers for Alzheimer's disease

Comparison of plasma phosphorylated tau at threonine 217 (p-tau217) levels measured at baseline and 3 months after study intervention will be compared. P-tau217 is a specific biomarker and a core biomarker for Alzheimer's disease. It is measured in picograms per milliliter.

Time frame
Baseline and 3 months after intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of North Norway

Lead sponsor

UiT The Arctic University of Norway

Collaborator