Alzheimer DiseasePhase 1AMBITIONNCT03998423
Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease
A Phase 1 study testing Fecal Microbiota Transplant in people with Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention for Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Fecal Microbiota Transplant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 14 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current enrollment in the Wisconsin ADRC clinical core study (2011-0030), ADCP (26695, MCW IRB), or referred from clinic
- At least 45 years of age
- Good general health (other than dementia) with no conditions/medications affecting the gut microbiome (see exclusion criteria below)
- Willing and able to comply with all study procedures for the duration of the study
- Able to provide signed and date informed consent form
- Participant is not pregnant, lactating or of childbearing potential (ie women must be two years post-menopausal or surgically sterile
Show all 12Show fewer
- Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception
- Able to take oral medications
- Able to take the test capsule successfully with no signs or symptoms of dysphagia
- Additional inclusion criteria for participants with Alzheimer's disease:
- Abnormal memory function documented by neuropsychological testing
- Wisconsin ADRC (HS IRB# 2015-0030) Consensus Diagnosis Conference indicates probable AD diagnosis as per NINDS/ADRDA criteria for probable AD (for ADRC and ADCP participants only).
Who cannot join
- Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial
- Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits (other than Alzheimer's dementia)
- Alcohol/substance: history of alcohol/substance dependence since joining the cohort
- Psychiatric disorders: Untreated current axis 1 DSM-V disorder such as major untreated depression, current untreated bipolar 1 disorder, untreated schizophrenia spectrum disorders, or other conditions potentially affecting study adherence.
- Significant medical illness: any significant systemic illness or unstable medical condition occurring that could affect cognition (other than Alzheimer's). Examples include malignant cancer, chemotherapy, untreated thyroid disease, heart failure, or renal insufficiency.
- Illiterate, blind, or non-English speaking
Show all 30Show fewer
- Known periodic antibiotic use (i.e. prior to dental appointments)
- Oral FMT-specific exclusion criteria:
- Inability (e.g. dysphagia) or unwilling to swallow capsules - assessed using the Eating Assessment Tool (EAT-10) and bedside 3oz water swallow test administered by CRU nurse or study coordinator
- Active gastrointestinal infection at time of enrollment
- Known or suspected toxic megacolon and/or known small bowel ileus
- History of total colectomy or bariatric surgery
- Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy
- Unable or unwilling to comply with protocol requirements
- Expected life expectancy < 6 months
- Previous FMT or microbiome-based products at any time excluding this study
- Patients with severe anaphylactic or anaphylactoid food allergy
- Solid organ transplant recipients ≤ 90 days post-transplant or on active treatment for rejection
- Immunocompromised/ at risk of CMV/EBV associated disease
- A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study
- Exclusionary factors affecting the microbiome:
- Use of systemic antibiotics (intravenous, intramuscular, or oral) in the previous 3 months
- Oral, intravenous, intramuscular, nasal or inhaled corticosteroids (except PRN use for allergies)
- Immune stimulating medications
- Methotrexate or immunosuppressive cytotoxic agents
- Large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day). Includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply).
- Unstable dietary history during the previous month, which is defined as major changes in diet by eliminating or significantly increasing a major good group
- Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years
- Major bowel resection at any time
- Active uncontrolled gastrointestinal disorders or disease including: inflammatory bowel disease including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (moderate-severe); persistent, infectious gastroenteritis, colitis or gastritis; persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), or chronic constipation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
About this study
The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention for Alzheimer's disease (AD).
Read the detailed description
Studies suggests that microbes, including those derived from the gut, may play a role in the development or progression of AD. Gut microbiome composition among individuals with the Alzheimer's clinical syndrome is reduced in microbial diversity and shows compositional differences relative to control groups. Further, genera identified as more abundant in AD are associated with greater AD pathology while genera identified as less abundant in AD are associated with less AD pathology, as shown using CSF biomarkers.
The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention.
- Primary Objective: To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral FMT intervention in people with and without the Alzheimer's clinical syndrome.
- Secondary Objective: To demonstrate the effects of FMT on the composition and function of the gut microbiota. To collect preliminary data in order to estimate sample size and other parameters for a larger study.
- Conditions
- Alzheimer Disease
- Being tested
- Fecal Microbiota Transplant
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantBiological
Also called FMT Capsule DE
Double-encapsulated Fecal Microbiota Transplant Capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 dose fecal microbiota transplant | Experimental | This group will receive one dose of Fecal Microbiota Transplant (FMT) at baseline. Receives: Biological: Fecal Microbiota Transplant |
| 2 doses fecal microbiota transplant | Experimental | This group will will receive one dose of Fecal Microbiota Transplant (FMT) at baseline and a second dose of FMT 8 weeks later. Receives: Biological: Fecal Microbiota Transplant |
| 3 doses fecal microbiota transplant | Experimental | This group will will receive one dose of Fecal Microbiota Transplant (FMT) at baseline, second dose of FMT at 8 weeks, and a third dose of FMT at 12 weeks. Receives: Biological: Fecal Microbiota Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest.
Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest.
Adverse events, serious adverse events, or adverse events of special interest, will be evaluated following study procedures using AE and SAE forms, telephone and in person interview, and relevant medical records related to adverse events.
Measured: 1 year
Feasibility: Participant recruitment rate
Number of weeks/months needed to meet study group numbers.
Measured: 1 year
Feasibility: Eligibility
Proportion of individuals expressing interest who meet inclusion/exclusion criteria.
Measured: 1 year
Feasibility: Procedures completed.
Proportion of participants able to complete procedures (including FMT) will be part of feasibility.
Measured: 1 year
Feasibility: Retention
Proportion of participants that complete follow up.
Measured: 1 year
Change in gut composition: Engraftment of fecal microbial transplant as assessed by 16S rRNA sequencing of recipient stool sample
In order to determine efficacy of fecal transplant, change in composition, i.e. microbial engraftment will be assessed by testing for newly detected operational taxonomic units (OTUs) in the gut microbiome of a participant post-FMT (which were present in the donor but undetected in the participant pre-FMT). This will be assessed via 16S rRNA seq of recipient stool samples pre- and post- FMT.
Measured: baseline, 8 weeks, 24 weeks, 1 year
Secondary outcomes (17)
Cognition: Change in Montreal Cognitive Assessment (MoCA) score
The Montreal Cognitive Assessment (MoCA) is a cognitive screening test used for detecting cognitive impairment. MoCA scores range between 0 and 30. Lower scores are indicative of impairment
Measured: baseline and 1 year
Cognition: Change in results of Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological Status consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory). Raw scores on each domain are scaled to account for a person's age. Scaled scores are converted to percentiles which are used to determine a range of performance (impaired, borderline impaired, expected score, high average, superior) and overall cognitive status (impaired/not impaired).
Measured: baseline and 1 year
Cognition: Change in the results of Trail Making Test Part A and Part B
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts, A and B. Participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: baseline and 1 year
Metabolic/physiological measure: Change in the level of Hemoglobin A1C
Change in the level of Hemoglobin A1C will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the level of fasting glucose
Change in the level of fasting glucose will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the level of fasting insulin
Change in the level of fasting insulin will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the level of C-reactive protein
Change in the level of C-reactive protein will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the blood lipid profile
Change in the blood lipid profile will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the blood pressure
Change in the blood pressure will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in body weight
Change in body weight will be assessed
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the body composition by measuring body fat percentage
Change in the body composition by measuring body fat percentage
Measured: baseline and 1 year
Change in insulin resistance indexed by the homeostatic model assessment-insulin resistance (HOMA-IR) method
Fasting glucose and fasting insulin will be used to calculate HOMA-IR.
Measured: baseline, 8 weeks, 24 weeks, and 1 year
Change in physical activity as measured by Actigraphy watch
Actigraphy watch will be worn on the non-dominant wrist was used to record a participant's physical activity (total number of active minutes per day).
Measured: baseline, 24 weeks, and 1 year
Change in Sleep as measured by Actigraphy watch
Actigraphy watch will be worn on the non-dominant wrist to estimate sleep duration.
Measured: baseline, 24 weeks, and 1 year
Change in CSF biomarkers
Aβ42, Aβ42/Aβ40, phosphorylated tau, total tau, YKL-40
Measured: baseline and 1 year
Change in serum/plasma metabolites on an average of one week pre and post FMT
Change in serum/plasma metabolites on an average of one week pre and post FMT
Measured: baseline, week 8, week 24, and 1 year
Function: Change in total score on the Bristol Activities of Daily Living Scale
Change in total score on the Bristol Activities of Daily Living Scale. This is a tool used to measure functional ability (ability to independently carry out activities of daily living), and was developed for use with people with dementia. The minimum score is "0". The maximum score is "60". A lower score (better) indicates that a person is independent in their activities of daily living, and a higher score (worse) indicates that the individual is dependent on others.
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start14 Nov 2019
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Why it stopped: SARS-CoV-2 has been detected in fecal material. Although FMT is screened for SARS-CoV-2, the team decided to end the study to minimize risk to participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single dose of 30 capsules (22.5g) of oral FMT will be given once (week 0), twice (week 0 and week 8), or three times (week 0, week 8, and week 24). Participants are randomly assigned to 1, 2, or 3 doses of FMT.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Partnership Program
- Responsible party
- Sponsor
- Investigators
- Barbara Bendlin, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998423
- Sponsor's protocol ID
- AMBITION
- Other IDs
- 2018-0283, A534255, SMPH/MEDICINE/MEDICINE
- Acronym
- AMBITION
- Status last verified
- Jul 2020
- First submitted
- 23 Aug 2018
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
PubMed 29051531
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03998423
- Acronym / sponsor ID
- AMBITION / AMBITION
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SARS-CoV-2 has been detected in fecal material. Although FMT is screened for SARS-CoV-2, the team decided to end the study to minimize risk to participants.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Partnership Program
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention for Alzheimer's disease (AD).
Detailed description
Studies suggests that microbes, including those derived from the gut, may play a role in the development or progression of AD. Gut microbiome composition among individuals with the Alzheimer's clinical syndrome is reduced in microbial diversity and shows compositional differences relative to control groups. Further, genera identified as more abundant in AD are associated with greater AD pathology while genera identified as less abundant in AD are associated with less AD pathology, as shown using CSF biomarkers.
The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention.
- Primary Objective: To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral FMT intervention in people with and without the Alzheimer's clinical syndrome.
- Secondary Objective: To demonstrate the effects of FMT on the composition and function of the gut microbiota. To collect preliminary data in order to estimate sample size and other parameters for a larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A single dose of 30 capsules (22.5g) of oral FMT will be given once (week 0), twice (week 0 and week 8), or three times (week 0, week 8, and week 24). Participants are randomly assigned to 1, 2, or 3 doses of FMT.
| Arm | Type | Receives |
|---|---|---|
| 1 dose fecal microbiota transplant | Experimental | Biological: Fecal Microbiota TransplantThis group will receive one dose of Fecal Microbiota Transplant (FMT) at baseline. |
| 2 doses fecal microbiota transplant | Experimental | Biological: Fecal Microbiota TransplantThis group will will receive one dose of Fecal Microbiota Transplant (FMT) at baseline and a second dose of FMT 8 weeks later. |
| 3 doses fecal microbiota transplant | Experimental | Biological: Fecal Microbiota TransplantThis group will will receive one dose of Fecal Microbiota Transplant (FMT) at baseline, second dose of FMT at 8 weeks, and a third dose of FMT at 12 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Current enrollment in the Wisconsin ADRC clinical core study (2011-0030), ADCP (26695, MCW IRB), or referred from clinic
- At least 45 years of age
- Good general health (other than dementia) with no conditions/medications affecting the gut microbiome (see exclusion criteria below)
- Willing and able to comply with all study procedures for the duration of the study
- Able to provide signed and date informed consent form
Key exclusion criteria (30 listed)
- Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial
- Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits (other than Alzheimer's dementia)
- Alcohol/substance: history of alcohol/substance dependence since joining the cohort
- Psychiatric disorders: Untreated current axis 1 DSM-V disorder such as major untreated depression, current untreated bipolar 1 disorder, untreated schizophrenia spectrum disorders, or other conditions potentially affecting study adherence.
- Significant medical illness: any significant systemic illness or unstable medical condition occurring that could affect cognition (other than Alzheimer's). Examples include malignant cancer, chemotherapy, untreated thyroid disease, heart failure, or renal insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantAlso: FMT Capsule DEDouble-encapsulated Fecal Microbiota Transplant Capsules | Biological | 1 dose fecal microbiota transplant, 2 doses fecal microbiota transplant, 3 doses fecal microbiota transplant |
Primary outcome
Safety: Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest.
Time frame: 1 year
Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest. Adverse events, serious adverse events, or adverse events of special interest, will be evaluated following study procedures using AE and SAE forms, telephone and in person interview, and relevant medical records related to adverse events.
Feasibility: Participant recruitment rate
Time frame: 1 year
Number of weeks/months needed to meet study group numbers.
Feasibility: Eligibility
Time frame: 1 year
Proportion of individuals expressing interest who meet inclusion/exclusion criteria.
Feasibility: Procedures completed.
Time frame: 1 year
Proportion of participants able to complete procedures (including FMT) will be part of feasibility.
Feasibility: Retention
Time frame: 1 year
Proportion of participants that complete follow up.
Change in gut composition: Engraftment of fecal microbial transplant as assessed by 16S rRNA sequencing of recipient stool sample
Time frame: baseline, 8 weeks, 24 weeks, 1 year
In order to determine efficacy of fecal transplant, change in composition, i.e. microbial engraftment will be assessed by testing for newly detected operational taxonomic units (OTUs) in the gut microbiome of a participant post-FMT (which were present in the donor but undetected in the participant pre-FMT). This will be assessed via 16S rRNA seq of recipient stool samples pre- and post- FMT.
17 secondary outcomes
Cognition: Change in Montreal Cognitive Assessment (MoCA) score
Time frame: baseline and 1 year
Cognition: Change in results of Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: baseline and 1 year
Cognition: Change in the results of Trail Making Test Part A and Part B
Time frame: baseline and 1 year
Metabolic/physiological measure: Change in the level of Hemoglobin A1C
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the level of fasting glucose
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the level of fasting insulin
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the level of C-reactive protein
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the blood lipid profile
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the blood pressure
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in body weight
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Metabolic/physiological measure: Change in the body composition by measuring body fat percentage
Time frame: baseline and 1 year
Change in insulin resistance indexed by the homeostatic model assessment-insulin resistance (HOMA-IR) method
Time frame: baseline, 8 weeks, 24 weeks, and 1 year
Change in physical activity as measured by Actigraphy watch
Time frame: baseline, 24 weeks, and 1 year
Change in Sleep as measured by Actigraphy watch
Time frame: baseline, 24 weeks, and 1 year
Change in CSF biomarkers
Time frame: baseline and 1 year
Change in serum/plasma metabolites on an average of one week pre and post FMT
Time frame: baseline, week 8, week 24, and 1 year
Function: Change in total score on the Bristol Activities of Daily Living Scale
Time frame: baseline and 1 year
Results and safety
The study was stopped early (reason given: SARS-CoV-2 has been detected in fecal material. Although FMT is screened for SARS-CoV-2, the team decided to end the study to minimize risk to participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Background: PubMed 29051531Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Bendlin, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplant in people with Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: SARS-CoV-2 has been detected in fecal material. Although FMT is screened for SARS-CoV-2, the team decided to end the study to minimize risk to participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest. (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.