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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for older adults with mild cognitive impairment or Alzheimer's disease. Participants will take an oral probiotic supplement and be involved in the study for up to one year.
Are You a Good Fit for This Trial?
Rules you outSignificant neurologic diseaseDiabetesSevere food allergies
You may be able to join if
I am at least 60 years old.
I have mild cognitive impairment or Alzheimer's disease.
I am in good general health besides my cognitive issues.
I can provide informed consent.
I am not pregnant or nursing.
I can take oral medications.
I have someone to help answer questions about me.
You may not be able to join if
I have participated in a related Alzheimer's clinical trial in the last 6 months.
I have a significant neurologic disease other than Alzheimer's.
I have a current diagnosis of diabetes.
I have a major medical illness that affects my cognition.
I have a history of substance dependence in the past year.
I have had major changes in my diet recently.
I have severe food allergies.
I cannot swallow capsules.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
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:
* Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)
…
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:
* Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)
* ADCP (26695, MCW IRB)
* Synapse study (2018-1283)
* ADRC Recruitment Registry (2016-0735)
* At least 60 years of age or older
* Good general health (other than cognitive impairment/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 dated informed consent form
* Participant is not pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)
* Able to take oral medications
* An informant to answer questionnaires about the participant
Additional inclusion criteria for unimpaired participants:
* Has MOCA score that falls within the range defined for cognitively healthy individuals
Additional inclusion criteria for participants with MCI/AD
* Abnormal cognitive function documented by neuropsychological testing
* ADRC (2015-0030) Consensus Diagnosis Conference indicates dementia or MCI due to AD (for ADRC, ADCP, and Synapse participants only)
* Meets NIA-AA criteria for MCI or AD.
Exclusion Criteria:
* Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial (can be included if previously enrolled in placebo or control group)
* Standard clinical care for dementia and medications used to treat MCI and Alzheimer's disease are acceptable, including monoclonal antibody therapy
* 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 or Mild Cognitive Impairment
* Alcohol/substance: history of alcohol/substance dependence in the past year.
* Significant medical illness: any significant systemic illness or unstable medical condition occurring during ADRC participation that could affect cognition (other than MCI/AD). Examples include malignant cancer, chemotherapy, HIV, untreated thyroid disease, heart failure, or renal insufficiency
* Current diagnosis with diabetes
* Illiterate, blind, or non-English speaking
* Known periodic antibiotic use (i.e., prior to dental appointments)
* Oral PS-specific exclusion criteria:
* Inability (e.g., dysphagia) or unwilling to swallow capsules
* 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 less than 6 months
* Previous use of probiotic supplementation (PS) or microbiome-based products within 2 months, large doses of commercial probiotics consumed (greater than or equal to 10\^8 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). Enrollment after 2 months without probiotic use can be considered for eligibility
* Patients with severe anaphylactic or anaphylactoid food allergy
* Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection
* A condition that would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the study, or would confound the results of the study
* Exclusionary factors affecting the microbiome:
* Previous use of systemic antibiotics (intravenous, intramuscular, or oral) within 3 months (depends on the duration of antibiotic use, i.e., less than 3 months is considered exclusion, however, enrollment after 3 months without antibiotic use can be considered for eligibility)
* Immune stimulating and/or suppressing medications
* Immunosuppressed as evaluated by complete blood count (CBC) with differential, which includes white blood cell count, total neutrophil count, and total lymphocyte count
* Unstable dietary history during the previous month, which is defined as major changes in diet by eliminating or significantly increasing a major food 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, 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
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