Evaluation of exploratory fluid biomarkers from a phase 1 senolytic trial in mild Alzheimer's disease

Garbarino VR, Palavicini JP, Gonzales MM, Orr ME, Musi N, Kirkland JL, Tchkonia T, Seshadri S, Bateman RJ

1. 01

   Open-label Phase 1 trial of dasatinib + quercetin (D+Q) in 5 adults with mild Alzheimer's disease

2. 02

   Confirmed CNS penetration of dasatinib and a favorable safety/tolerability profile

3. 03

   No statistically significant change across exploratory tau, amyloid, or neuroinflammatory fluid biomarkers

4. 04

   No significant change in secondary cognitive or neuroimaging endpoints

5. 05

   Underpowered proof-of-concept (n=5); a Phase 2 randomized controlled trial in AD is underway

Study Design

Clinical Trial

Sample Size

5 subjects

Study Duration

~12 weeks (intermittent dosing)

Methodology

Open-label, single-arm Phase 1 feasibility trial; intermittent oral D+Q dosing; exploratory analysis of CSF and plasma biomarkers with secondary cognitive and neuroimaging endpoints.

Limitations

Very small open-label sample (n=5) with no placebo control; not powered for efficacy. Exploratory biomarker analysis only; findings are hypothesis-generating and should not be read as evidence of a disease-modifying effect.