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Extension Study of Participants From SPG302-ALZ-101

NCT ID: NCT06833281

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2025-10-09

Brief Summary

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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)

Detailed Description

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This is an open-label extension study of SPG302-ALZ-101 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with mild-to-moderate AD. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's Disease synapse neural connectivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label extension
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Extension

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.

Group Type EXPERIMENTAL

SPG302

Intervention Type DRUG

small synthetic molecule

Interventions

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SPG302

small synthetic molecule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spinogenix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Priest, MBBS

Role: PRINCIPAL_INVESTIGATOR

Flinders Medical Center, Adelaide, SA, Australia

Brew Brew, MBBS, MD, DSC

Role: PRINCIPAL_INVESTIGATOR

St Vincents Hospital, Sydney, NSW, Australia

Locations

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St. Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Flinders Medical Center

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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SPG302-ALZ-102 OLE

Identifier Type: -

Identifier Source: org_study_id