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SAPHARY

Not yet recruitingPhase 2

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

Asset

GAL-101 Salt

Listed sites

0

Recruiting sites

-

Enrollment

100

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/CSF/plasma)•Tau biomarker required (PET/CSF/plasma)•Study partner/caregiver required•Background AD symptomatic therapy, if used: stable

Primary endpoint

•Adverse Events

Identifiers

Registered as

Org study IDGAL-101-C0202
NCT IDNCT07789873

Timeline

Milestones

Study first posted2026-08-27actual
Last update posted2026-08-27actual
Study start2027-02-28estimated
Primary completion2028-04-30estimated
Study completion2028-07-31estimated

Assets

Drug assets

GAL-101 Salt

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neurodegeneration biomarkers
1
Safety / tolerability / PK
1

Neurodegeneration biomarkers

1 endpoint
Secondary/protocol endpoint

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, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants With Adverse Events

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

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.