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A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease

Study acronym: SAPHARY
StatusNot Yet Recruiting
PhasePhase 2
Started2027-02-28
View on ClinicalTrials.gov ↗
This Phase 2a study will evaluate the safety and tolerability of GAL-101 in approximately 100 participants with mild to moderate Alzheimer's disease associated with amyloid-beta pathology. Participants will be randomly assigned to receive either 1200 mg of GAL-101 salt or matching placebo tablets by mouth once daily for 28 days. Neither the participants nor the study team will know which treatment each participant receives during the study. The study will also explore whether GAL-101 affects brain-wave activity measured using quantitative electroencephalography, Alzheimer's disease-related biomarkers in cerebrospinal fluid, and performance on cognitive tests. Blood and cerebrospinal fluid samples will be collected to evaluate how GAL-101 is absorbed and distributed in the body.
Trial Details
NCT Number NCT07789873
Lead Sponsor Galimedix Therapeutics Inc
Conditions Mild to Moderate Alzheimer's Disease
Enrollment 100 participants
Start Date 2027-02-28
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-27