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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06833281




Registration number
NCT06833281
Ethics application status
Date submitted
12/02/2025
Date registered
18/02/2025
Date last updated
16/04/2025

Titles & IDs
Public title
Extension Study of Participants From SPG302-ALZ-101
Scientific title
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)
Secondary ID [1] 0 0
SPG302-ALZ-102 OLE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPG302

Experimental: 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.


Treatment: Drugs: SPG302
small synthetic molecule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events and serious adverse events
Timepoint [1] 0 0
Up to 52 weeks
Primary outcome [2] 0 0
C-SSRS (Columbia Suicide Severity Rating Scale)
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
Timepoint [1] 0 0
up to 52 weeks
Secondary outcome [2] 0 0
Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
Timepoint [2] 0 0
up to 52 weeks
Secondary outcome [3] 0 0
Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
Timepoint [3] 0 0
up to 52 weeks
Secondary outcome [4] 0 0
Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
Timepoint [4] 0 0
up to 52 weeks
Secondary outcome [5] 0 0
Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint
Timepoint [5] 0 0
up to 52 weeks
Secondary outcome [6] 0 0
Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.
Timepoint [6] 0 0
up to 52 weeks
Secondary outcome [7] 0 0
Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.
Timepoint [7] 0 0
up to 52 weeks

Eligibility
Key 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
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spinogenix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lauren Priest, MBBS
Address 0 0
Flinders Medical Center, Adelaide, SA, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06833281