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

NCT07789873 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • Mild to Moderate Alzheimer's Disease

Interventions

DRUG

GAL-101 Salt

GAL-101 salt will be administered orally as two 600 mg tablets, for a total dose of 1200 mg once daily for 28 days. The tablets may be taken with or without food.

DRUG

Placebo

Matching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.

Sponsors & Collaborators

  • Galimedix Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2028-04-30
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789873 on ClinicalTrials.gov