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

Brief summary

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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

SAPHARY

status

NOT_YET_RECRUITING

phase

PHASE2

study type

INTERVENTIONAL

enrollment

100

sponsor

Galimedix Therapeutics Inc

conditions

Mild to Moderate Alzheimer's Disease

interventions

DRUG: GAL-101 Salt; DRUG: Placebo

start date

2027-02-28

start date type

ESTIMATED

primary completion date

2028-04-30

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters