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NCT Number: NCT07789873

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.

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Key information

Conditions

Mild to Moderate Alzheimer's Disease Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GAL-101 Salt

Drug

GAL-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

Drug

Matching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From the first dose through 4 weeks after the last dose, approximately 8 weeks

    Number of participants who experience one or more adverse events following administration of GAL-101 salt or placebo.

Secondary outcomes

  1. Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation

    Time frame: Baseline to the end of the 28-day treatment perio

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luciana Summo, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Galimedix Therapeutics Inc

Industry

Registry information

Acronym: SAPHARY

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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