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Lay Description

Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study

Category

  • Nervous System
IRB Number
20190850HU
NCT Number
NCT04200911
Open to Enrollment
No

Eligibility

Eligible Ages
Between 55 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Diagnosis of Mild Cognitive Impairment (MCI), Clinical Dementia Rating Scale (CDR)=0.5-1; Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall ≤5% based on age-adjusted normal values, clinician approved
  • Normal blood cell counts without clinically significant excursions
  • A Legally Authorized Representative (LAR) if necessary for consent
  • An LAR or study partner to accompany participant to all visits
  • Availability for all study visits
  • Stable dose of AD medications) Donepezil, rivastigmine, memantine, galantamine) for at least 3 months

Exclusion Criteria

  • Diabetes (HbA1c≥6.5% or anti-diabetic medications)
  • History of skin ulcers or poor wound healing
  • Current tobacco or illicit drug use or alcohol abuse
  • Use of anti-platelet or anti-coagulant medications other than aspirin
  • Current medications that affect cytochrome P450 3A4
  • Immunosuppressant therapy within the last year
  • Chemotherapy or radiation treatment within the last year
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities
  • Current or chronic history of pulmonary disease or abnormal pulse oximetry (<90%)
  • Chronic heart failure
  • Pregnancy
  • Recent history (past 6 months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
  • significant neurological conditions other than AD
  • Poorly controlled blood pressure (systolic BP>160, diastolic BP>90mmHg)
  • Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or psychiatric disease
  • History of, or Magnetic Resonance Imaging (MRI) positive for any space occupying lesion, including mass effect and/or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Mitzi Gonzales
(210) 450-9047
gonzalesm20@uthscsa.edu

Regulatory Point of Contact
Floyd Jones
+1 (210) 450-3158
jonesfa@uthscsa.edu

Regulatory Point of Contact
Antoinette Lewis
(210) 562-5040
lewisa7@uthscsa.edu

Local Recruitment Point of Contact
Floyd Jones
+1 (210) 450-3158
jonesfa@uthscsa.edu

Local Recruitment Point of Contact
Antoinette Lewis
(210) 562-5040
lewisa7@uthscsa.edu

Principal Investigator
Mitzi Gonzales