NCT07789873Not yet recruitingPhase 2
A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 28 Feb 2027
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Galimedix Therapeutics Inc
- Diseases
- Alzheimer disease
- NCT number
- NCT07789873
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 28 Feb 2027 to the primary completion date, 30 Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
Other
- Inability to comply with the study schedule or procedures.
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.