Alzheimer's DiseasePhase 2NCT06833281
Extension Study of Participants From SPG302-ALZ-101
A Phase 2 study testing SPG302 in people with Alzheimer's Disease, run by Spinogenix at 2 sites in Australia.
Trial 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) Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SPG302
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesAustralia
- Study dates
- 25 Mar 2025to 9 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Flinders Medical Center
Adelaide, South Australia, 5000
St. Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official 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)
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)
Read the detailed description
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
- Alzheimer's Disease
- Being tested
- SPG302
- Keywords
- Alzheimer's Disease, synapse, neural connectivity
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG302Drug
small synthetic molecule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SPG302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events and serious adverse events
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: 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.
Measured: Up to 52 weeks
Secondary outcomes (7)
Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
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.
Measured: up to 52 weeks
Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
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.
Measured: up to 52 weeks
Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
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.
Measured: up to 52 weeks
Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
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.
Measured: up to 52 weeks
Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint
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.
Measured: up to 52 weeks
Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.
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.
Measured: up to 52 weeks
Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.
To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start25 Mar 2025
- Primary completion30 Jul 2025
- Study completion9 Oct 2025
Why it stopped: patients treated on compassionate use program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label extension
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lauren Priest, MBBS, Principal investigator, Flinders Medical Center, Adelaide, SA, AustraliaBrew Brew, MBBS, MD, DSC, Principal investigator, St Vincents Hospital, Sydney, NSW, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833281
- Sponsor's protocol ID
- SPG302-ALZ-102 OLE
- Status last verified
- Dec 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06833281
- Acronym / sponsor ID
- SPG302-ALZ-102 OLE
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, synapse, neural connectivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patients treated on compassionate use program
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SpinogenixIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label extension
| Arm | Type | Receives |
|---|---|---|
| Open Label Extension | Experimental | Drug: SPG302Active SPG302 to be administered to adult participants with AD who completed initial study. Dose to be administered to be dose received during previous study. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPG302small synthetic molecule | Drug | Open Label Extension |
Primary outcome
Treatment emergent adverse events and serious adverse events
Time frame: Up to 52 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
C-SSRS (Columbia Suicide Severity Rating Scale)
Time frame: Up to 52 weeks
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.
7 secondary outcomes
Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
Time frame: up to 52 weeks
Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
Time frame: up to 52 weeks
Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
Time frame: up to 52 weeks
Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
Time frame: up to 52 weeks
Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint
Time frame: up to 52 weeks
Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.
Time frame: up to 52 weeks
Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.
Time frame: up to 52 weeks
Results and safety
The study was stopped early (reason given: patients treated on compassionate use program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Priest, MBBS principal investigator
Flinders Medical Center, Adelaide, SA, Australia
Brew Brew, MBBS, MD, DSC principal investigator
St Vincents Hospital, Sydney, NSW, Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPG302 in people with Alzheimer's Disease, run by Spinogenix at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: patients treated on compassionate use program). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events and serious adverse events (time frame: Up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.