Printed from Voxsanity (voxsanity.com.au) — NCT07413744 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting
NCT07413744
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People diagnosed with Mild Cognitive Impairment (MCI), Alzheimer's disease, or who have no memory or thinking problems, and who were referred from a Wisconsin clinic in the Wisconsin Alzheimer's Institute network or recruited from the community.
- People who may have previously taken part in one of these studies: the Alzheimer's Disease Research Center (ADRC) clinical core study, ADCP, the Synapse study, or the ADRC Recruitment Registry.
- People aged 60 years or older.
- People who are generally in good health apart from any memory or thinking problems, and who do not have conditions or take medications known to affect gut bacteria (confirm with trial site).
- People who are willing and able to follow all study procedures for the full length of the trial.
- People who are able to read, understand, and sign a consent form.
- Women who are not pregnant, not breastfeeding, and are not able to become pregnant — meaning they are at least two years past menopause or have had a surgical procedure that prevents pregnancy.
- People who are able to swallow oral medications (tablets or capsules taken by mouth).
- People who have someone in their life (such as a family member or carer) who can answer questionnaires about them.
- For people with no memory or thinking problems: a score on the MoCA memory test that falls within the normal range for cognitively healthy individuals.
- For people with MCI or Alzheimer's disease: memory or thinking problems confirmed by formal neuropsychological testing.
- For people with MCI or Alzheimer's disease who participated in the ADRC, ADCP, or Synapse studies: a diagnosis of dementia or MCI due to Alzheimer's disease confirmed through the ADRC Consensus Diagnosis Conference.
- For people with MCI or Alzheimer's disease: meeting the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI or Alzheimer's disease (confirm with trial site).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who are currently taking part in, or have taken part in, an Alzheimer's treatment trial or intervention within the past 6 months — though people who were in a placebo or control group may still be considered.
- Note: Standard dementia care and medications used to treat MCI or Alzheimer's disease, including monoclonal antibody therapies, are acceptable and do not exclude participation.
- People with another significant brain or nervous system condition, such as Parkinson's disease, stroke, Huntington's disease, brain tumour, multiple sclerosis, epilepsy (seizure disorder), or similar conditions beyond Alzheimer's or MCI.
- People with a history of alcohol or substance dependence in the past year.
- People with a serious or unstable physical health condition that could affect memory or thinking (other than MCI or Alzheimer's), such as active cancer, HIV, untreated thyroid disease, heart failure, or kidney insufficiency.
- People who currently have a diagnosis of diabetes.
- People who are unable to read, are blind, or do not speak English.
- People who are known to use antibiotics regularly on a scheduled basis (for example, before dental appointments).
- People who are unable or unwilling to swallow capsules, including those with swallowing difficulties.
- People who have an active gut infection at the time of joining the trial.
- People with a condition called toxic megacolon or small bowel ileus (confirm with trial site).
- People who have had their entire large bowel (colon) removed, or who have had weight-loss (bariatric) surgery.
- People currently receiving intensive chemotherapy, radiation therapy, or biological treatment for active cancer.
- People who are unable or unwilling to follow the study's required procedures.
- People whose life expectancy is expected to be less than 6 months.
- People who have used probiotic supplements or microbiome-based products within the past 2 months, or who regularly consume high-dose commercial probiotics (100 million or more live organisms per day) in tablet, capsule, lozenge, chewing gum, or powder form — note that everyday fermented foods such as yoghurt, fermented drinks, and similar foods are not included in this restriction. People who have stopped probiotic supplement use for at least 2 months may be considered for eligibility.
- People with a severe, life-threatening food allergy (anaphylaxis or anaphylactoid reaction).
- People who have received a solid organ transplant within the past 90 days, or who are currently being treated for organ rejection.
- People with any other condition that could put their safety or rights at risk, make it unlikely they would complete the study, or affect the reliability of the study results.
- People who have used systemic antibiotics (taken by mouth, injection, or drip) within the past 3 months — people who have been antibiotic-free for at least 3 months may be considered for eligibility.
- People taking medications that stimulate or suppress the immune system.
- People whose immune system is considered suppressed based on blood test results (confirm with trial site).
- People whose diet has changed significantly in the past month, such as cutting out or greatly increasing a major food group.
- People who have had major surgery on their digestive tract in the past five years — removal of the gallbladder or appendix is not excluded.
- People who have had a large portion of their bowel surgically removed at any time.
- People with active, uncontrolled digestive or bowel conditions, including inflammatory bowel disease, ulcerative colitis, Crohn's disease, indeterminate colitis, moderate-to-severe irritable bowel syndrome, ongoing infectious gastroenteritis or colitis, unexplained persistent or chronic diarrhoea, recurrent Clostridioides difficile infection, untreated Helicobacter pylori infection, or chronic constipation.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Barbara Bendlin, PhD, UW School of Medicine and Public Health
Phone: 608-263-9485
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 March 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study; Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study; Feasibility: Number of weeks or months needed to meet study group numbers; Feasibility: Proportion of individuals expressing interest in study who are Eligible; Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS; Feasibility: Proportion of Participants Who Complete Intervention
Can't join this trial?
Data last synced from ClinicalTrials.gov: 18 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.