Health TrialsbyHealthPanel

Effects of Sirolimus on Asymptomatic ApoE4 Carriers

ConditionsGenetic Predisposition to DiseaseHealthy VolunteerAPOE-4 Positive
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorUniversity of Missouri-Columbia

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sirolimus (rapamycin)

    Drug

    Participants in Sirolimus arm will receive Sirolimus.

  • Placebo

    Drug

    Participants in the Placebo arm will receive Placebo

Treatment groups

225 Participants
are divided into 2 treatment groups
Group A: SirolimusActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Cerebral Blood Flow as measured by MRI

Rate of blood perfusion expressed as mL/100g/min globally and regionally

Time frame
Baseline to 4 weeks

Secondary outcomes

1

Measure the change in plasma Marker-cytokine using a Meso Scale Discovery (MSD) analyzer.

Time frame
Baseline to 4 weeks
2

Measure baseline to post-treatment changes in Plasma Markers-AD pathology using a Meso Scale Discovery (MSD) analyzer

Time frame
Baseline to 4 weeks
3

Measure brain function connectivity by fMRI

Time frame
Baseline to 4 weeks
4

Measurement of blood brain barrier by MRI

Time frame
Baseline to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri-Columbia

Lead sponsor

Source ClinicalTrials.gov
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