Extension Study of Participants From SPG302-ALZ-101

NCT06833281 | Terminated Phase 2 DMC

• 1 other identifier: SPG302-ALZ-102 OLE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALZ-101 with mild to moderate Alzheimer's Disease (AD)

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; synapse; neural connectivity

Outcome Measures

Primary Outcomes (2)

• Treatment emergent adverse events and serious adverse events

  Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Up to 52 weeks

• C-SSRS (Columbia Suicide Severity Rating Scale)

  Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale evaluates the level of actual or potential medical damage. The range is 0-25.Min is 0 and Max is 25.

  Up to 52 weeks

Secondary Outcomes (7)

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

  up to 52 weeks

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

  up to 52 weeks

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

  up to 52 weeks

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

  up to 52 weeks

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

  up to 52 weeks

Study Arms (1)

Open Label Extension

EXPERIMENTAL

Active SPG302 to be administered to adult participants with AD who completed initial study. Dose to be administered to be dose received during previous study.

Drug: SPG302

Interventions

SPG302 DRUG

small synthetic molecule

Open Label Extension

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spinogenix: lead

Study Sites (2)

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Flinders Medical Center

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lauren Priest, MBBS

  Flinders Medical Center, Adelaide, SA, Australia

  PRINCIPAL INVESTIGATOR

• Brew Brew, MBBS, MD, DSC

  St Vincents Hospital, Sydney, NSW, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label extension

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: March 25, 2025
• Primary Completion: July 30, 2025
• Study Completion: October 9, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

AU (2)