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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
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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)
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Secondary ID [1]
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SPG302-ALZ-102 OLE
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment emergent adverse events and serious adverse events
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Assessment method [1]
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Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
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Timepoint [1]
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Up to 52 weeks
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Primary outcome [2]
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C-SSRS (Columbia Suicide Severity Rating Scale)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 52 weeks
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Secondary outcome [1]
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Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
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Assessment method [1]
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The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language and visual-spatial skills. The lower the score the greater the impairment. The range is 0-30. Min is 0 and Max is 30.
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Timepoint [1]
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up to 52 weeks
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Secondary outcome [2]
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Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
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Assessment method [2]
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The ADAS-COG measures language and memory, focusing on cognitive and non-cognitive functioning. It evaluates word recall, naming of objects, word recognition, comprehension and word finding. The ADAS-COG is scored 0-70. Min is 0 and Max is 70. The higher the score the greater the impairment.
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Timepoint [2]
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up to 52 weeks
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Secondary outcome [3]
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Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
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Assessment method [3]
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The QOL-AD is a test to evaluate the quality of life through a series of questions of ability to complete daily activities and tasks. A lower score indicates lower functional quality of life. Per question scored at 1-2-3-4. Overall range is Min is 13 and Max is 52.
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Timepoint [3]
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up to 52 weeks
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Secondary outcome [4]
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Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
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Assessment method [4]
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The ADCS - CGIC is a metric for clinical assessment of symptom severity. It consists of 2 parts. First a baseline evaluation of patient and caregiver is performed to collect necessary clinical information. The clinician will then conduct the second phase of the assessment after a specified time period, and changes in symptom severity are indicated on a seven-point scale. A higher scale indicates a worsening of symptoms. Range is 1-7. Min 1 and Max is 7.
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Timepoint [4]
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up to 52 weeks
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Secondary outcome [5]
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Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint
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Assessment method [5]
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The CDR-SB is an interview performed with patient and caregiver, and will stage the severity of cognitive impairment. The higher the score, the greater the impairment. Range is 0-18. Min is 0 and Max is 18.
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Timepoint [5]
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up to 52 weeks
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Secondary outcome [6]
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Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.
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Assessment method [6]
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The ADCS-ADL is a metric to assess the ability to perform basic and instrumental activities of daily living. It is completed by a caregiver as a questionnaire or interview questions, and evaluates activities within the previous four weeks. Changes in symptom severity are indicated on a seven-point scale. A lower scale indicates greater impairment. Each question is 0-3. Total score is 78. Min is 0 and Max is 78.
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Timepoint [6]
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up to 52 weeks
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Secondary outcome [7]
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Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.
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Assessment method [7]
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To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter
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Timepoint [7]
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up to 52 weeks
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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
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Minimum age
45
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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St. Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Flinders Medical Center - Adelaide
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Spinogenix
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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)
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Trial website
https://clinicaltrials.gov/study/NCT06833281
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lauren Priest, MBBS
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Address
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Flinders Medical Center, Adelaide, SA, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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
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