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

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

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.

GAL-101 oral was previously evaluated in a Phase 1 study in healthy adult and elderly participants (ClinicalTrials.gov Identifier: NCT07780604)

Inclusion Criteria:

• 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.
• Availability of a reliable trial partner, caregiver, or legal representative who has contact with the participant for at least 10 hours per week and can support study participation.
• Able and willing to provide informed consent and comply with study requirements.
• In sufficiently good health, in the investigator's opinion, to participate in the study.
• If receiving an acetylcholinesterase inhibitor or memantine, treatment must be at a stable dose for the protocol-specified period.

Exclusion Criteria:

• 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.
• Clinically significant or unstable cardiovascular, respiratory, renal, hepatic, metabolic, infectious, or malignant disease.
• Active major depression, schizophrenia, bipolar disorder, or clinically significant suicide risk.
• Known or suspected hypersensitivity to GAL-101, placebo, or their components.
• A scalp condition that would prevent adequate electroencephalography assessment.
• Inability to comply with the study schedule or procedures.
• Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.