Study record
Senolytic therapy in mild Alzheimer's disease (SToMP-AD): open-label CNS-penetration pilot (Gonzales et al., 2023)
Human open-label pilot (feasibility / biomarker)
○ Evidence tier 3 — Human open-label pilot (feasibility / biomarker)
Record
| Design | Open-label feasibility pilot |
| N | 5 |
| Registry | NCT04063124 |
| Citation status | registry corrected & verified via ClinicalTrials.gov v2 API: NCT04063124 = open-label single-group pilot, n=5 ACTUAL, UT Health San Antonio, COMPLETED 2023-01-30. NOTE: NCT04685590 is a SEPARATE follow-on Phase 2 randomized quadruple-masked trial (n=48 target, active). Outcomes paper Gonzales et al. 2023. |
Five-qualifier claim
| Species / population | Older adults with early-stage Alzheimer's disease (n=5 ACTUAL), open-label single-group pilot (NCT04063124). |
| Exposure, route, schedule | Intermittent oral D+Q over 12 weeks. |
| Comparator / duration | Single-arm; CSF sampled at baseline and 12 weeks. |
| Endpoint / numeric result | Primary endpoint CNS penetration: dasatinib detected in CSF (0.281-0.536 ng/mL) in 4/5 participants; quercetin not detected. Well tolerated. Cognitive and neuroimaging measures did not significantly change. |
| What it did NOT establish | Feasibility/pharmacokinetic pilot only; no cognitive benefit demonstrated; no lifespan outcome. |
Interventions
Primary reference
https://clinicaltrials.gov/study/NCT04063124
Exact identifier to be confirmed against the primary record before publication where flagged above.