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

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.