Is NCT07413744 recruiting in Madison, WI?

Yes, NCT07413744 is currently recruiting participants at its Madison, WI location. This alzheimer disease clinical trial is actively enrolling qualified participants.

How do I join the alzheimer disease clinical trial in Madison?

To join this clinical trial in Madison, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Madison clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Alzheimer Disease Clinical Trial in Madison, WI

About This Alzheimer Disease Study in Madison

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.

Sponsor: University of Wisconsin, Madison

Who Can Participate

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

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Madison?

Yes, this clinical trial (NCT07413744) has an active research site in Madison, WI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alzheimer Disease Treatment Options in Madison, WI

If you're searching for alzheimer disease treatment options in Madison, WI, this clinical trial (NCT07413744) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Madison research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced alzheimer disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alzheimer disease clinical trials near you to find additional studies recruiting in your area.

Alzheimer Disease Clinical Trial in Madison, WI

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