SToMP-AD: Senolytic Therapy for Alzheimer’s Disease

A treatment to remove dysregulated cells found in mild cognitive impairment and Alzheimer’s disease.

SToMP-AD is studying a therapy of two medications for mild cognitive impairment and Alzheimer’s disease. The medications, dasatanib, a FDA approved drug to treat cancers, and quercetin, a natural antioxidant, have been well-tolerated and may remove cells that have been dysregulated with age, which can contribute to tissue damage and disease. In this study, participants may receive senolytics or a placebo.

Eligibility  

Qualifications to participate include, but are not limited to:

• • Must be at least 60 years old
  • Diagnosis of mild cognitive impairment or early Alzheimer’s disease
  • A legal authorized representative who can attend all study visits with the participant. This representative must be a person who can legally provide consent to participate in a clinical trial on your behalf. This individual may be a legal guardian or a person designated as your surrogate decision maker by a medical power of attorney or advance directive. If you do not have a legal guardian or surrogate decision maker, another person, such as your spouse, may serve as your representative.

Non-eligibility

Disqualifications to participate include, but are not limited to, a diagnosis in the past six months of either:

• Myocardial infarction/heart attack or angina (chest pain) or
• Stroke or transient ischemic attack (TIA)

Participation

Participation in the study includes completing 13 scheduled visits at UT Health San Antonio over a period of 58 weeks.

The first two visits will assess eligibility and consist of:

• • A medical history review including review of current medications
  • Physical exam and vital signs assessment
  • Brief cognitive tests
  • Blood work
  • Lumbar puncture to assess levels of tau in the cerebrospinal fluid.

At the next visit, participants will receive:

• Cognitive and physical functioning assessments
• Brain MRI
• Tau PET imaging

At the third visit, participants will randomly be chosen to receive either the study drug or the placebo for 3 months. As this study is a double-blind study, neither the participant nor the administering provider will know if the participant has received the drug or placebo. During the next visits, participants will receive:

• Vital assessments
• A medical history review including review of current medications
• Blood work
• Administration of placebo or active study drug

After 3 months of receiving the study drug or placebo, participants will receive:

• • Lumbar puncture
  • Cognitive assessments
  • Brain MRI

At 3, 6 and 9 months after visit 10, participants will receive:

• Safety, cognitive, functional and outcomes assessments
• Tau PET imaging at visit 13
• Optional third lumbar puncture at visit 13

Compensation

There is no cost to participate. Participants will be compensated for time and travel to visits. The payment amount and schedule will be reviewed at the time of consent.

Meet Your Clinical Research Team

Peter T. Fox, MD

Mitzi M. Gonzales, PhD, ABPP-CN

Mohamad Habes, PhD

Tiffany F. Kautz, PhD

Nicolas Musi, MD

Sarah Savoia, PAC

Sudha Seshadri, MD