NCT07789873 · Phase 2 · NOT YET RECRUITING
A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease
This trial tests GAL-101, a daily pill, in about 100 people with mild to moderate Alzheimer's who already have confirmed amyloid-beta pathology. Over 28 days, researchers will check safety, brain-wave activity, spinal fluid biomarkers, and cognitive test scores compared to placebo. It's a Phase 2a study — an early look at safety and initial effects, not proof it works.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-27