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.
Male or female participants aged 50 to 85 years, inclusive.
Clinical diagnosis of Alzheimer's disease at the mild or moderate dementia stage (Stages 4 or 5) according to the 2018 National Institute on Aging and Alzheimer's Association criteria
Evidence of amyloid-beta pathology based on cerebrospinal fluid biomarkers, amyloid-beta positron emission tomography, or plasma phosphorylated tau 217.
Evidence of cognitive decline during the previous year.
A neurological, psychiatric, cerebrovascular, or other medical condition that could explain the participant's cognitive impairment, interfere with study assessments, or create an unacceptable safety risk.
Previous treatment with anti-amyloid-beta immunotherapy.
Participation in another interventional clinical study or receipt of an investigational drug within 3 months before screening.
Use of prohibited medications or substances that could affect cognition, electroencephalography assessments, safety, or interpretation of the study results.
Parallel
GAL-101 Salt
DrugGAL-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.
Placebo
DrugMatching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.
Number of Participants With Adverse Events
Number of participants who experience one or more adverse events following administration of GAL-101 salt or placebo.
Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation
Change from baseline in global alpha-band corrected amplitude envelope correlation (AEC-c), assessed using quantitative electroencephalography. AEC-c is used to evaluate functional connectivity and synaptic activity in the brain.
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