TerminatedPhase 2

Extension Study of Participants From SPG302-ALZ-101

An Open-label Extension of SPG302-ALZ-101 Study to Evaluate the Long-term Safety and Efficacy of Daily Oral SPG302 Treatment in Participants With Mild-to-Moderate Alzheimer's Disease (AD)

Lead sponsor

Spinogenix

Asset

SPG302

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•mild-to-moderate AD

Primary endpoints

•Treatment emergent adverse events and serious adverse events•C-SSRS

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06833281

Org study IDSPG302-ALZ-102 OLE

Timeline

Milestones

Study first posted2025-02-18actual

Study start2025-03-25actual

Primary completion2025-07-30actual

Study completion2025-10-09actual

Last update posted2025-12-18actual

Assets

Drug assets

SPG302

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of mild to moderate AD

•Clinical laboratory values within normal range or < 1.5 times ULN

•Life expectancy of >2 years

•Able and willing to provide written informed consent

•Must have participated in all study activities of SPG302-ALZ-101, the parent study

Exclusion criteria

Any physical or psychological condition that prohibits study completion

•Known cardiac disease

•Active or history of malignancy in the past 5 years

•Serious infection that will not be resolved by first day of study intervention.

•History of clinically significant CNS event or diagnosis in the past 5 years.

•Acute illness within 30 days of Day 1

•History of suicidal behavior or suicidal ideation

•History of chronic alcohol use or substance abuse in the last 5 years

•HIV, hepatitis B and/or hepatitis C positive

•Vaccines within 14 days

•Receipt of investigational products within 30 days

•Blood donation within 30 days

•Pregnant or breastfeeding

Endpoints (9)

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

Global cognition

Caregiver / quality of life

Function / daily living

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Safety / tolerability / PK

Global cognition

3 endpoints

Secondary/protocol endpoint

Change in Mini-Mental State Examination (MMSE) from baseline to endpoint

Time frame:up to 52 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint

Time frame:up to 52 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint

Time frame:up to 52 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.

Time frame:up to 52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

C-SSRS (Columbia Suicide Severity Rating Scale)

Time frame:Up to 52 weeks

descriptive

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.

Time frame:up to 52 weeks

Neurofilament light (NfL)

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint

Time frame:up to 52 weeks

descriptive

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint

Time frame:up to 52 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Treatment emergent adverse events and serious adverse events

Time frame:Up to 52 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 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 July 21, 2026 snapshot.