Genetic Predisposition to DiseasePhase 1NCT07728175
Effects of Sirolimus on Asymptomatic ApoE4 Carriers
A Phase 1 study testing Sirolimus (rapamycin) in people with Genetic Predisposition to Disease and Healthy Volunteer, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease, Healthy Volunteer, APOE-4 Positive
- What is being tested?
- Sirolimus (rapamycin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 7 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nathan Bresette contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Kim Ray, 573-884-5372, raykk@health.missouri.edu
Nathan Bresette, nbhtd@missouri.edu
About this study
Official title: Effects of Sirolimus on Middle Aged Asymptomatic ApoE4 Carriers
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.
Read more
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
- Being tested
- Sirolimus (rapamycin), Placebo
- Keywords
- ApoE4 positive, Cerebral Blood Flow, Sirolimus, Rapamycin, Magnetic Resonance Imaging
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus (rapamycin)Drug
Participants in Sirolimus arm will receive Sirolimus.
PlaceboDrug
Participants in the Placebo arm will receive Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus | Active comparator | Not described Receives: Drug: Sirolimus (rapamycin) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebral Blood Flow as measured by MRI
Rate of blood perfusion expressed as mL/100g/min globally and regionally
Measured: Baseline to 4 weeks
Secondary outcomes (6)
Measure the change in plasma Marker-cytokine using a Meso Scale Discovery (MSD) analyzer.
Measured: Baseline to 4 weeks
Measure baseline to post-treatment changes in Plasma Markers-AD pathology using a Meso Scale Discovery (MSD) analyzer
Measured: Baseline to 4 weeks
Measure brain function connectivity by fMRI
Measured: Baseline to 4 weeks
Measurement of blood brain barrier by MRI
Measured: Baseline to 4 weeks
Measurement of brain oxygenation by MRI
Measured: Baseline to 4 weeks
Measurement of glucose uptake in the brain by PET imaging
Glucose uptake in the brain globally and regionally
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion7 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai-Ling Lin, PhD, University of Missouri-Columbia
- Investigators
- Ai-Ling Lin, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728175
- Sponsor's protocol ID
- 2134312
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects. Am Fam Physician. 2007 Aug 1;76(3):391-6.
PubMed 17708140Lin AL, Aware C, Neher C, Hamdi M, Ericsson A, Khegai O, Patrie J, Kurt M, Govindarajan M, Woods C, Ivanich K, Beversdorf D, Cheng J, Balchandani P, Gonzales M, Altes T. Rapamycin enhances neurovascular, peripheral metabolic, and immune function in cognitively normal, middle-aged APOE4 Carriers: genotype-dependent effects compared to non-carriers. Res Sq [Preprint]. 2025 Mar 19:rs.3.rs-6214340. doi: 10.21203/rs.3.rs-6214340/v1.
PubMed 40166019Ozcelik S, Fraser G, Castets P, Schaeffer V, Skachokova Z, Breu K, Clavaguera F, Sinnreich M, Kappos L, Goedert M, Tolnay M, Winkler DT. Rapamycin attenuates the progression of tau pathology in P301S tau transgenic mice. PLoS One. 2013 May 7;8(5):e62459. doi: 10.1371/journal.pone.0062459. Print 2013.
PubMed 23667480Mannick JB, Del Giudice G, Lattanzi M, Valiante NM, Praestgaard J, Huang B, Lonetto MA, Maecker HT, Kovarik J, Carson S, Glass DJ, Klickstein LB. mTOR inhibition improves immune function in the elderly. Sci Transl Med. 2014 Dec 24;6(268):268ra179. doi: 10.1126/scitranslmed.3009892.
PubMed 25540326Lelegren M, Liu Y, Ross C, Tardif S, Salmon AB. Pharmaceutical inhibition of mTOR in the common marmoset: effect of rapamycin on regulators of proteostasis in a non-human primate. Pathobiol Aging Age Relat Dis. 2016 Jun 23;6:31793. doi: 10.3402/pba.v6.31793. eCollection 2016.
PubMed 27341957Sills AM, Artavia JM, DeRosa BD, Ross CN, Salmon AB. Long-term treatment with the mTOR inhibitor rapamycin has minor effect on clinical laboratory markers in middle-aged marmosets. Am J Primatol. 2019 Feb;81(2):e22927. doi: 10.1002/ajp.22927. Epub 2018 Oct 12.
PubMed 30311681Tardif S, Ross C, Bergman P, Fernandez E, Javors M, Salmon A, Spross J, Strong R, Richardson A. Testing efficacy of administration of the antiaging drug rapamycin in a nonhuman primate, the common marmoset. J Gerontol A Biol Sci Med Sci. 2015 May;70(5):577-87. doi: 10.1093/gerona/glu101. Epub 2014 Jul 19.
PubMed 25038772Ross C, Salmon A, Strong R, Fernandez E, Javors M, Richardson A, Tardif S. Metabolic consequences of long-term rapamycin exposure on common marmoset monkeys (Callithrix jacchus). Aging (Albany NY). 2015 Nov;7(11):964-73. doi: 10.18632/aging.100843.
PubMed 26568298Spilman P, Podlutskaya N, Hart MJ, Debnath J, Gorostiza O, Bredesen D, Richardson A, Strong R, Galvan V. Inhibition of mTOR by rapamycin abolishes cognitive deficits and reduces amyloid-beta levels in a mouse model of Alzheimer's disease. PLoS One. 2010 Apr 1;5(4):e9979. doi: 10.1371/journal.pone.0009979.
PubMed 20376313Lin AL, Parikh I, Yanckello LM, White RS, Hartz AMS, Taylor CE, McCulloch SD, Thalman SW, Xia M, McCarty K, Ubele M, Head E, Hyder F, Sanganahalli BG. APOE genotype-dependent pharmacogenetic responses to rapamycin for preventing Alzheimer's disease. Neurobiol Dis. 2020 Jun;139:104834. doi: 10.1016/j.nbd.2020.104834. Epub 2020 Mar 12.
PubMed 32173556
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sirolimus on Middle Aged Asymptomatic ApoE4 Carriers
- ClinicalTrials.gov ID
- NCT07728175
- Acronym / sponsor ID
- 2134312
- Keywords
- ApoE4 positive, Cerebral Blood Flow, Sirolimus, Rapamycin, Magnetic Resonance Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 7 Jul 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus | Active comparator | Drug: Sirolimus (rapamycin) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus (rapamycin)Participants in Sirolimus arm will receive Sirolimus. | Drug | Sirolimus |
| PlaceboParticipants in the Placebo arm will receive Placebo | Drug | Placebo |
Primary outcome
Change in Cerebral Blood Flow as measured by MRI
Time frame: Baseline to 4 weeks
Rate of blood perfusion expressed as mL/100g/min globally and regionally
6 secondary outcomes
Measure the change in plasma Marker-cytokine using a Meso Scale Discovery (MSD) analyzer.
Time frame: Baseline to 4 weeks
Measure baseline to post-treatment changes in Plasma Markers-AD pathology using a Meso Scale Discovery (MSD) analyzer
Time frame: Baseline to 4 weeks
Measure brain function connectivity by fMRI
Time frame: Baseline to 4 weeks
Measurement of blood brain barrier by MRI
Time frame: Baseline to 4 weeks
Measurement of brain oxygenation by MRI
Time frame: Baseline to 4 weeks
Measurement of glucose uptake in the brain by PET imaging
Time frame: Baseline to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 17708140Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects. Am Fam Physician. 2007 Aug 1;76(3):391-6.
- Background: PubMed 40166019Lin AL, Aware C, Neher C, Hamdi M, Ericsson A, Khegai O, Patrie J, Kurt M, Govindarajan M, Woods C, Ivanich K, Beversdorf D, Cheng J, Balchandani P, Gonzales M, Altes T. Rapamycin enhances neurovascular, peripheral metabolic, and immune function in cognitively normal, middle-aged APOE4 Carriers: genotype-dependent effects compared to non-carriers. Res Sq [Preprint]. 2025 Mar 19:rs.3.rs-6214340. doi: 10.21203/rs.3.rs-6214340/v1.
- Background: PubMed 23667480Ozcelik S, Fraser G, Castets P, Schaeffer V, Skachokova Z, Breu K, Clavaguera F, Sinnreich M, Kappos L, Goedert M, Tolnay M, Winkler DT. Rapamycin attenuates the progression of tau pathology in P301S tau transgenic mice. PLoS One. 2013 May 7;8(5):e62459. doi: 10.1371/journal.pone.0062459. Print 2013.
- Background: PubMed 25540326Mannick JB, Del Giudice G, Lattanzi M, Valiante NM, Praestgaard J, Huang B, Lonetto MA, Maecker HT, Kovarik J, Carson S, Glass DJ, Klickstein LB. mTOR inhibition improves immune function in the elderly. Sci Transl Med. 2014 Dec 24;6(268):268ra179. doi: 10.1126/scitranslmed.3009892.
- Background: PubMed 27341957Lelegren M, Liu Y, Ross C, Tardif S, Salmon AB. Pharmaceutical inhibition of mTOR in the common marmoset: effect of rapamycin on regulators of proteostasis in a non-human primate. Pathobiol Aging Age Relat Dis. 2016 Jun 23;6:31793. doi: 10.3402/pba.v6.31793. eCollection 2016.
- Background: PubMed 30311681Sills AM, Artavia JM, DeRosa BD, Ross CN, Salmon AB. Long-term treatment with the mTOR inhibitor rapamycin has minor effect on clinical laboratory markers in middle-aged marmosets. Am J Primatol. 2019 Feb;81(2):e22927. doi: 10.1002/ajp.22927. Epub 2018 Oct 12.
- Background: PubMed 25038772Tardif S, Ross C, Bergman P, Fernandez E, Javors M, Salmon A, Spross J, Strong R, Richardson A. Testing efficacy of administration of the antiaging drug rapamycin in a nonhuman primate, the common marmoset. J Gerontol A Biol Sci Med Sci. 2015 May;70(5):577-87. doi: 10.1093/gerona/glu101. Epub 2014 Jul 19.
- Background: PubMed 26568298Ross C, Salmon A, Strong R, Fernandez E, Javors M, Richardson A, Tardif S. Metabolic consequences of long-term rapamycin exposure on common marmoset monkeys (Callithrix jacchus). Aging (Albany NY). 2015 Nov;7(11):964-73. doi: 10.18632/aging.100843.
- Background: PubMed 20376313Spilman P, Podlutskaya N, Hart MJ, Debnath J, Gorostiza O, Bredesen D, Richardson A, Strong R, Galvan V. Inhibition of mTOR by rapamycin abolishes cognitive deficits and reduces amyloid-beta levels in a mouse model of Alzheimer's disease. PLoS One. 2010 Apr 1;5(4):e9979. doi: 10.1371/journal.pone.0009979.
- Background: PubMed 32173556Lin AL, Parikh I, Yanckello LM, White RS, Hartz AMS, Taylor CE, McCulloch SD, Thalman SW, Xia M, McCarty K, Ubele M, Head E, Hyder F, Sanganahalli BG. APOE genotype-dependent pharmacogenetic responses to rapamycin for preventing Alzheimer's disease. Neurobiol Dis. 2020 Jun;139:104834. doi: 10.1016/j.nbd.2020.104834. Epub 2020 Mar 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Bresette contact
Ai-Ling Lin, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sirolimus (rapamycin) in people with Genetic Predisposition to Disease and Healthy Volunteer, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Ray (573-884-5372, umhsradstudycoordinators@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cerebral Blood Flow as measured by MRI (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728175, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.