Recent Updates
Recently added Catalysts

GAL-101 Salt

Phase 2

Mild to Moderate Alzheimer's Disease | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Aug 27, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

GAL-101 Salt · 1 trial · 1 indication

Phase 2 1
NCT07789873A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's DiseaseMild to Moderate Alzheimer's Disease
NOT YET_RECRUITING100 Analytics
PHASE2NOT YET_RECRUITING
A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease
Mild to Moderate Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events
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 Endpoints

Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation
Baseline to the end of the 28-day treatment perio
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GAL-101 1200 mgEXPERIMENTALParticipants will receive two 600 mg GAL-101 salt tablets orally once daily for 28 days. Treatment may be administered with or without food.
PlaceboPLACEBO_COMPARATORParticipants will receive two matching placebo tablets orally once daily for 28 days. Treatment may be administered with or without food.

Interventions

NameTypeDescription
GAL-101 SaltDRUGGAL-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.
PlaceboDRUGMatching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.
Unlock Study Design Details

Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo

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 path...

Unlock Eligibility Criteria