Active not recruitingPhase 2

Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)

A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302

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

•Electroencephalogram (EEG) at resting state•ADAS-Cog•Mini-Mental State Examination (MMSE)

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 IDNCT06427668

Org study IDSPG302-ALZ-101

Timeline

Milestones

Study first posted2024-05-24actual

Study start2024-07-29actual

Last update posted2025-08-17actual

Primary completion2025-12estimated (month precision)

Study completion2026-06estimated (month precision)

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

•Age 45-85

•Diagnosis of mild to moderate AD

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

•If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.

•Life expectancy of >2 years

•Able and willing to provide written informed consent

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 (10)

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

Safety / tolerability / PK

Function / daily living

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Fluid / digital biomarkers

Global cognition

2 endpoints

Primary/protocol endpoint

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

Time frame:8 months

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

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

Time frame:8 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Primary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint

Time frame:8 months

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

C-SSRS (Columbia Suicide Severity Rating Scale)

Time frame:8 months

descriptive

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Change in biomarkers in participants with AD from baseline to endpoint.

Time frame:8 months

Neurofilament light (NfL)

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Primary/protocol endpoint

Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint

Time frame:8 months

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

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

Time frame:8 months

change from baseline, improvement

Primary/protocol endpoint

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

Time frame:8 months

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Safety and tolerability of SPG302

Time frame:8 months

event count, event

Secondary/protocol endpoint

Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)

Time frame:8 months

concentration, descriptive

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.