A Phase 1 interventional study of Probiotic and Placebo in Alzheimer Disease, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment
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Among 24 studies in Alzheimer Disease by University of Wisconsin, Madison — 6 open to participants now, 6 under way, none of them phase 3. Alzheimer Disease · University of Wisconsin, Madison.
Among the 24 studies in Alzheimer Disease by University of Wisconsin, Madison, this one is the 11th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2026, is one of 2 in phase 1, and was the 23rd registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →6 of the 24 studies in Alzheimer Disease by University of Wisconsin, Madison are open now, in 1 country. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 50+ · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 40–80 · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 18+ · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 45–89 · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8 · Phase 3 2 · Phase 4 1
First in 2001; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 42 across the 17 interventional studies, 206 across the 7 observational. Of the 18 that completed or were terminated, 8 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
2 of the studies in Alzheimer Disease by University of Wisconsin, Madison that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05592366University of Wisconsin, MadisonDementia Care Partner Hospital Assessment Tool | 2027-05 |
| NCT07812337University of Wisconsin, MadisonEvaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care | 2027-11-15 |
Add all 2 to your calendar (.ics) → With an account.
Among the 24 studies in Alzheimer Disease by University of Wisconsin, Madison, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.
40 participants will be enrolled. 20 with dementia or mild cognitive impairment (MCI) due to Alzheimer's disease (biomarker confirmed amyloid positivity), and 20 unimpaired cognition, enriched for elevated amyloid (approximately 75-80% amyloid positive). Dementia/mild cognitive impairment will be determined according to 2024 NIA-AA criteria.
Primary Objective
Exploratory Objectives
Inclusion Criteria:
MCI/AD or cognitively unimpaired, referred from a Wisconsin clinic that is part of the Wisconsin Alzheimer's Institute's (WAI) network, or recruited from the community. May have participated in:
Additional inclusion criteria for unimpaired participants:
Additional inclusion criteria for participants with MCI/AD
Exclusion Criteria:
Oral PS-specific exclusion criteria:
Exclusionary factors affecting the microbiome:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnosis of mild cognitive impairment (MCI) or dementia
Drug: Probiotic
Diagnosis of mild cognitive impairment (MCI) or dementia
Other: Placebo
Drug: Probiotic
Other: Placebo
A single dose of oral PS will be administered once daily for 6 months
Also known as: Encapsulated probiotic preparation
A placebo will be given once daily for 6 months.
Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study
Time frame: up to 36 weeks
Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study
Time frame: up to 36 weeks
Feasibility: Number of weeks or months needed to meet study group numbers
Time frame: up to 36 weeks
Feasibility: Proportion of individuals expressing interest in study who are Eligible
Time frame: baseline
Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS
Time frame: week 24
Feasibility: Proportion of Participants Who Complete Intervention
Time frame: up to 36 weeks
Hemoglobin A1C
Time frame: baseline, week 12, week 24, and week 36
Fasting Glucose
Time frame: baseline, week 12, week 24, week 36
Fasting Insulin
Time frame: baseline, week 12, week 24, week 36
C-reactive protein
Time frame: baseline, week 12, week 24, week 36
Blood lipid profile
Time frame: baseline, week 12, week 24, week 36
Systolic Blood Pressure
Time frame: baseline, week 12, week 24, week 36
Diastolic Blood Pressure
Time frame: baseline, week 12, week 24, week 36
Body Weight
Time frame: baseline, week 12, week 24, week 36
Body Fat Percentage
Time frame: baseline, week 12, week 24, week 36
Insulin Resistance indexed by the homeostatic model assessment-insulin resistance (HOMA-IR) method
Time frame: baseline, week 12, week 24, week 36
Change in Quality of Sleep
General sleep quality will be rated using a 10 item questionnaire, which uses a 6-point Likert scale. Scores range from 10-60, with higher scores indicating better sleep quality.
Time frame: baseline, week 12, week 24, week 36
Metabolites
Measured from serum, plasma, stool
Time frame: baseline, week 12, week 24, week 36
Gut Microbiome Composition
Change in gut microbiome composition will be assessed using 16srRNA seq and metagenomic analysis of stool samples.
Time frame: baseline, week 12, week 24, week 36
Plasma Biomarkers of Alzheimer's Disease Related Dementias (ADRD)
Change in plasma biomarkers of ADRD, including pTau217, neurofilament light chain (NfL), and Glial Fibrillary Acidic Protein (GFAP). Emerging plasma biomarkers may also be assessed.
Time frame: baseline, week 12, week 24, week 36
Change in Montreal Cognitive Assessment (MoCA) score
The MoCA is a cognitive screening test used for detecting cognitive impairment. MoCA scores range between 0 and 30. Lower scores are indicative of impairment.
Time frame: screening, week 24, week 36
Change in Repeatable Battery for the Assessment of Neuropsychological Status: Performance
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).
Time frame: baseline, week 24, week 36
Change in Repeatable Battery for the Assessment of Neuropsychological Status: Cognitive 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 overall cognitive status (impaired/not impaired).
Time frame: baseline, week 24, week 36
Change in the results of Trail Making Test (TMT)
The TMT 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.
Time frame: baseline, week 24, week 36
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.
Time frame: baseline, week 12, week 24, week 36
Intestinal Permeability
Investigators may measure proteins or other markers related to intestinal permeability (in blood).
Time frame: baseline, week 12, week 24, week 36
Change in Epworth Sleepiness Scale (ESS)
ESS is an 8 item questionnaire, using a 4-point Likert scale. Scores range from 0-24, with higher scores indicating greater levels of sleepiness throughout the day.
Time frame: baseline, week 12, week 24, week 36
Change in Insomnia Severity Index (ISI)
ISI is an 7 item questionnaire, using a 5-point Likert scale. Scores range from 35-24, with higher scores indicating greater levels of insomnia.
Time frame: baseline, week 12, week 24, week 36
Change in Pittsburgh Sleep Quality Index (PSQI)
PSQI scoring involves summing scores from 7 components, each ranging from 0 (no difficulty) to 3 (severe difficulty), to get a global score from 0 to 21, with higher scores indicating worse sleep quality. A global score over 5 suggests significant sleep difficulties.
Time frame: baseline, week 12, week 24, week 36
Plan to share: Yes — Collected specimens (including stool, blood, and CSF) will be stored and may be used for future research. Participants will be asked to consent to the use of the samples for future research.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The samples will be kept until all analyses for this project are complete or until the samples are exhausted.
Access criteria: Drs. Bendlin and Rey will review all requests to utilize the data, tissue, and results of specimen analysis.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2029, 34 months later.
Of 73 non-industry phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's planned 34 months is below that.
Counting every sponsor, half of 234 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Probiotic
University of Wisconsin, Madison →