Is NCT07728175 recruiting in Columbia, MO?

Yes, NCT07728175 is currently recruiting participants at its Columbia, MO location. This genetic predisposition to disease clinical trial is actively enrolling qualified participants.

Is participation in this Columbia 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.

Genetic Predisposition to Disease Clinical Trial in Columbia, MO

Q: How do I join the genetic predisposition to disease clinical trial in Columbia?

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

About This Genetic Predisposition to Disease Study in Columbia

Alzheimer's disease is a devastating neurodegenerative disease characterized by accumulation of clumps (also called plaques) and bundles of fibers (also called tangles) in the brain, for which there is currently no cure. Sirolimus (Rapamycin) is an FDA-approved medication which may improve the blood flow to the brain. The purpose of the clinical trial is to find out whether sirolimus can help improve blood flow and energy use in the brain in women ages 45 to 65 who have the ApoE4 gene, a gene which increases the risk of developing Alzheimer's disease later in life. There will be two arms in this trail, a sirolimus arm and a placebo arm. A placebo is a pill that looks like the study drug, but it does not have any real medicine in it. Participants will be randomized to one arm or the other, but not to both arms. Three study visits over a 12-week period are required. Participants will: (i) Complete some questionnaires about how well you think; (ii) Complete genetic testing for the ApoE4 gene; (iii) Have blood work, blood pressure and height and weight collected; (iv) Take either Sirolimus or a placebo daily, by mouth, for approximately 4 weeks; (v) Keep a diary of when the sirolimus or placebo is taken; (vi) Complete 2 Magnetic Resonance Imaging (MRI) exams

Sponsor: University of Missouri-Columbia

Who Can Participate

Inclusion Criteria

Willing and able to provide informed consent

Sex assigned at birth: female

45-65 years old

Able to perform self-care and activities of daily living with no or minimal assistance

Post-menopausal status or use of highly effective contraception. Post-menopausal is defined as either

12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms)

surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to screening. For oophorectomy alone, post-menopausal status must be confirmed by follow-up hormone level assessment

Highly effective contraception includes intrauterine devices (IUD), oral contraceptives, or other hormonal contraceptives including injectables, transdermal patches, implants or vaginal rings, or refraining from heterosexual intercourse during the 4 weeks of taking the study drug and for 2 weeks after no longer taking the study drug

Body weight of ≥ 40 kg

Ability to effectively communicate with the investigator and comply with study requirements

Exclusion Criteria

Diagnosis of mild cognitive impairment (MCI), dementia, or Alzheimer's disease

BMI ≥ 35 (based on MRI feasibility)

Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c ≥ 6.5%)

History of skin ulcers or poor wound healing

Current tobacco or illicit drug use or alcohol abuse (defined as ≥ 3 per day or ≥ 7 per week for women) (Per NIAAA guidelines)

Use of anti-platelet or anti-coagulant medications other than aspirin

Required use of medications that affect cytochrome P450 3A4 (CYP3A4) or alter cerebral blood flow (see Appendix 1 for tables of excluded medications)

Immunosuppressant therapy within the last year

Chemotherapy or radiation treatment within the last year

Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities

Untreated hypertriglyceridemia (fasting triglycerides \< 300 mg/dl)

Current or chronic significant history of pulmonary disease

Chronic heart failure

Pregnancy or lactation

Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack

Poorly controlled blood pressure (systolic BP \> 160 or diastolic BP \> 100 mmHg)

Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness

History of, or MRI, or CT positive for, any space occupying brain lesion, including mass effect or abnormal intracranial pressure

Organ transplant recipients

History of Stroke

History of ruptured intracranial aneurysm

History of malignancy within the past 2 years, with the following exceptions:

Localized basal cell or squamous cell carcinoma of the skin

Prostate cancer confined to the gland (AJCC stage T2N0M0 or better)

Cervical carcinoma in situ

Breast cancer localized to the breast

History of epilepsy

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 Columbia?

Yes, this clinical trial (NCT07728175) has an active research site in Columbia, MO 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.

Genetic Predisposition to Disease Treatment Options in Columbia, MO

If you're searching for genetic predisposition to disease treatment options in Columbia, MO, this clinical trial (NCT07728175) 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 Columbia research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced genetic predisposition to 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 genetic predisposition to disease clinical trials near you to find additional studies recruiting in your area.

Genetic Predisposition to Disease Clinical Trial in Columbia, MO

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