Probiotics for Alzheimer's Disease

AB
Overseen ByAlfred Braceros, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a probiotic supplement is safe and feasible for individuals with Alzheimer's disease or mild cognitive issues. Researchers aim to determine if the probiotics can benefit these conditions. Participants will be divided into groups: some will receive the probiotic, while others will receive a placebo (a pill with no active ingredient). The trial seeks individuals diagnosed with memory problems or at risk for Alzheimer's who can adhere to the study guidelines for a year. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important early-stage findings.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that probiotics are generally safe and well-tolerated by people with Alzheimer's disease (AD) and mild cognitive impairment (MCI). Studies have found that probiotics can improve thinking and memory and reduce symptoms related to AD and MCI. For instance, one study found that probiotics improved mental performance in patients with these conditions. Another review suggests that probiotics not only aid cognitive function but also manage stomach issues, which are common in these patients.

Importantly, probiotics have been used in many clinical trials without major safety concerns, indicating their safety for use. However, consulting a healthcare provider before starting any new treatment is always advisable.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard treatments for Alzheimer's disease, which often involve medications like cholinesterase inhibitors and memantine, this new approach uses probiotics. Researchers are excited because probiotics could offer a natural way to influence gut health, which is increasingly linked to brain health through the gut-brain axis. This treatment is unique because it leverages live microorganisms to potentially improve cognitive function, offering a novel mechanism of action compared to existing drugs that primarily target neurotransmitter levels. By exploring this link, the treatment may provide a fresh perspective and new possibilities for managing Alzheimer's symptoms.

What evidence suggests that this probiotic might be an effective treatment for Alzheimer's disease?

Research has shown that probiotics might improve thinking and memory in people with Alzheimer's disease or mild memory problems. In this trial, some participants will receive probiotics, while others will receive a placebo. A review of several studies found that taking probiotics for at least 12 weeks led to noticeable improvements in thinking skills. Most studies reported better overall scores on memory and thinking tests after using probiotics. Some research suggests that probiotics might help by reducing inflammation and stress in the body. However, a few studies showed mixed results, with improvements varying across different thinking skills. Overall, promising evidence suggests that probiotics could help with memory and thinking issues related to Alzheimer's.16789

Who Is on the Research Team?

BB

Barbara Bendlin, PhD

Principal Investigator

UW School of Medicine and Public Health

FR

Federico Rey, PhD

Principal Investigator

Department of Bacteriology

Are You a Good Fit for This Trial?

Inclusion Criteria

* Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)
* ADCP (26695, MCW IRB)
* Synapse study (2018-1283)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an oral probiotic supplement or placebo for up to 36 weeks

36 weeks
Visits at baseline, week 12, week 24, and week 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Probiotic

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cognitively Unimpaired Amyloid Positive: ProbioticExperimental Treatment1 Intervention
Group II: Cognitively Impaired due to AD: ProbioticExperimental Treatment1 Intervention
Group III: Cognitively Impaired due to AD: PlaceboPlacebo Group1 Intervention
Group IV: Cognitively Unimpaired Amyloid Positive: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

International Flavors & Fragrances Inc.

Collaborator

Trials
1
Recruited
210+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41237466/

A meta-analysis of randomized controlled trials

Cognitive improvements were most pronounced with supplementation durations of at least 12 weeks (SMD = 0.73; 95 % CI, 0.30-1.16; P = 0.0009) and ...

Effectiveness of probiotic supplements on cognitive ...

Cognitive improvements were most pronounced with supplementation durations of at least 12 weeks (SMD = 0.73; 95 % CI, 0.30–1.16; P = 0.0009) and higher ...

Systematic review of probiotic supplementation in ...

Some trials reported statistically significant improvements in selected cognitive outcomes, inflammatory and oxidative stress markers, metabolic parameters, ...

Probiotics for Mild Cognitive Impairment and Alzheimer's ...

Our findings suggest that dietary supplementation with probiotics improves cognitive function, especially in people with MCI.

Probiotic Supplementation Improves the Clinical Measures of ...

All studies but one demonstrated a statistically significant improvement in total cognitive test scores, while all studies showed a significant ...

Efficacy and Safety of Probiotics for the Treatment ...

Our analyses suggest that probiotics can improve cognitive and gastrointestinal symptoms in patients with AD, MCI, and PD.

Probiotics for Alzheimer's Disease: A Systematic Review - PMC

Probiotics are known to be one of the best preventative measures against cognitive decline in AD. Numerous in vivo trials and recent clinical trials have proven ...

The microbiota–gut–brain axis in mild cognitive impairment ...

Probiotic and dietary interventions are promising to modulate the microbiota–cognition axis. More longitudinal human studies are needed to ...

Effect of a Probiotic Formula in Mild Cognitive Impairement

This project is a clinical-nutritional trial to evaluate the utility of consuming a dietary supplement containing probiotics on the cognitive ...