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

NCT07789873 | Not Yet Recruiting Phase 2

• 1 other identifier: GAL-101-C0202
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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; Cognitive Function; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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 Outcomes (1)

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

  Baseline to the end of the 28-day treatment perio

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

GAL-101 1200 mg

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.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• Galimedix Therapeutics Inc: lead

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luciana Summo, PhD

CONTACT

info@galimedix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): February 28, 2027
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share