Senolytic Therapy for Alzheimer's Disease
(SToMP-AD Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byMiranda Orr, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing drugs in older adults with early signs of cognitive decline and tau protein tangles in their brains. These drugs aim to remove old, damaged cells to reduce inflammation and other issues, potentially improving symptoms. The combination of dasatinib and quercetin has shown an acceptable safety profile in other conditions.

Research Team

Miranda Orr, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults aged 65 and older with mild cognitive impairment or early-stage Alzheimer's Disease, who have elevated tau protein levels. Participants must be on a stable dose of FDA-approved AD medications for at least three months, able to consent (or have a representative), and have a study partner. They should not plan extensive travel during the study and must speak English fluently.

Inclusion Criteria

Participants must have no travel plans that would interfere with scheduling visits following consent over the 12 months of study duration

Your total cholesterol should be less than 240 mg/dl, and your HbA1c level should be 7% or lower.

Your blood clotting tests (PT/PTT/INR) are normal.

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Exclusion Criteria

I have not had a heart attack, chest pain, stroke, or mini-stroke in the last 6 months.

You cannot have an MRI if you are claustrophobic, have metal implants, or a cardiac pacemaker.

I cannot take medicine by mouth.

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Treatment Details

Interventions

Senolytic Therapy (Senolytic)

Trial OverviewThe SToMP-AD Study is testing the safety and effectiveness of senolytic therapy using Dasatinib plus Quercetin compared to placebo capsules in slowing down Alzheimer's progression in patients with positive tau PET scans.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Dasatinib (D) is given as (1) 100mg capsule daily for 2 consecutive days (Sprycel®, Bristol Myers Squibb). Quercetin (Q) will be given as (4) 250 mg capsules daily (total 1000 mg daily) for the same 2 consecutive days (Thorne Research). Both are administered orally.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo capsules following the same administration protocol as the experimental treatment - administered once daily (1st dose of each cycle will be given, supervised, at the clinic visit; the 2nd dose will be taken at home) for 2 consecutive days followed by a 13-day (+/- 2 day) no-drug period for 12 consecutive weeks for 6 rounds of administration.