Mild to Moderate Alzheimer's DiseasePhase 2SAPHARYNCT07789873
A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing GAL-101 Salt in people with Mild to Moderate Alzheimer's Disease, run by Galimedix Therapeutics Inc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild to Moderate Alzheimer's Disease
- What is being tested?
- GAL-101 Salt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2027to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Luciana Summo, PhD contact
About this study
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.
Read the detailed description
GAL-101 oral was previously evaluated in a Phase 1 study in healthy adult and elderly participants (ClinicalTrials.gov Identifier: NCT07780604)
- Conditions
- Mild to Moderate Alzheimer's Disease
- Being tested
- GAL-101 Salt, Placebo
- Keywords
- GAL-101, Amyloid-Beta, Pathology Synaptic Plasticity, Quantitative Electroencephalography qEEG, Cerebrospinal Fluid Biomarkers, Neurogranin, SNAP-25, VAMP2, Cognitive Function, Pharmacokinetics
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAL-101 SaltDrug
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.
PlaceboDrug
Matching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.
| Study group | Role | What they receive |
|---|---|---|
| GAL-101 1200 mg | Experimental | Participants will receive two 600 mg GAL-101 salt tablets orally once daily for 28 days. Treatment may be administered with or without food. Receives: Drug: GAL-101 Salt |
| Placebo | Placebo comparator | Participants will receive two matching placebo tablets orally once daily for 28 days. Treatment may be administered with or without food. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants who experience one or more adverse events following administration of GAL-101 salt or placebo.
Measured: From the first dose through 4 weeks after the last dose, approximately 8 weeks
Secondary outcomes (1)
Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation
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.
Measured: Baseline to the end of the 28-day treatment perio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start28 Feb 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galimedix Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789873
- Sponsor's protocol ID
- GAL-101-C0202
- Acronym
- SAPHARY
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07789873
- Acronym / sponsor ID
- SAPHARY / GAL-101-C0202
- Conditions
- Mild to Moderate Alzheimer's Disease
- Keywords
- GAL-101, Amyloid-Beta, Pathology Synaptic Plasticity, Quantitative Electroencephalography qEEG, Cerebrospinal Fluid Biomarkers, Neurogranin, SNAP-25, VAMP2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Galimedix Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GAL-101 oral was previously evaluated in a Phase 1 study in healthy adult and elderly participants (ClinicalTrials.gov Identifier: NCT07780604)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAL-101 1200 mg | Experimental | Drug: GAL-101 SaltParticipants will receive two 600 mg GAL-101 salt tablets orally once daily for 28 days. Treatment may be administered with or without food. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive two matching placebo tablets orally once daily for 28 days. Treatment may be administered with or without food. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAL-101 SaltGAL-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. | Drug | GAL-101 1200 mg |
| PlaceboMatching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food. | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation
Time frame: Baseline to the end of the 28-day treatment perio
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luciana Summo, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GAL-101 Salt in people with Mild to Moderate Alzheimer's Disease, run by Galimedix Therapeutics Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciana Summo, PhD (info@galimedix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From the first dose through 4 weeks after the last dose, approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.