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

August 24, 2026 updated by: Galimedix Therapeutics Inc

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GAL-101 1200 mg
Participants will receive two 600 mg GAL-101 salt tablets orally once daily for 28 days. Treatment may be administered with or without food.
Drug: GAL-101 Salt
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 Comparator: Placebo
Participants will receive two matching placebo tablets orally once daily for 28 days. Treatment may be administered with or without food.
Drug: Placebo
Matching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the first dose through 4 weeks after the last dose, approximately 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to the end of the 28-day treatment perio

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galimedix Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2027

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAL-101-C0202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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