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Alzheimer DiseasePhase 2NCT06427668

Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)

A Phase 2 study testing SPG302 in people with Alzheimer Disease, run by Spinogenix at 2 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD. Read more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
SPG302
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
2 sitesAustralia
Study dates
29 Jul 2024to Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age 45-85
  • Diagnosis of mild to moderate AD
  • Clinical laboratory values within normal range or < 1.5 times ULN
  • If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.
  • Life expectancy of >2 years
  • Able and willing to provide written informed consent

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

Other trials in Australia

About this study

Official title: A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302

This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.

Read the detailed description

This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:

Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles

Part B: a randomized expansion cohort of daily dosing for 28 day cycles

Being tested
SPG302, Placebo
Keywords
Alzheimer Disease, synapse, neural connectivity, Dementia
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPG302Drug

    synthetic small molecule

  • PlaceboDrug

    Placebo

Study groups in NCT06427668
Study groupRoleWhat they receive
Part A: Active SPG302 to be administered to adult participants with ADActive comparatorCohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be 300 mg orally once daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to cohort 2: 12 additional participants pending review of data, for additional dose exploration.
Receives: Drug: SPG302
Part A: Placebo comparator to be administered to adult participants with ADPlacebo comparatorCohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be placebo capsule orally daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to 12 additional participants as cohort 2 pending review of data, for additional dose exploration.
Receives: Drug: Placebo
Part B: Expansion CohortExperimentalDose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A.
Receives: Drug: SPG302

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint

    Electroencephalogram (EEG) will provide non-invasive measurement of brain activity. This test will be used to measure resting state cognitive activity as well as cognitive activity after auditory stimulation. Sound stimuli is 500Hz and 2000Hz.

    Measured: 8 months

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

    The Alzheimer's Disease Assessment Scale-Cognitive Subscale test (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. The higher the score the greater the impairment.

    Measured: 8 months

  3. 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.

    Measured: 8 months

  4. 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 inquires about the level of actual or potential medical damage.

    Measured: 8 months

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

    The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (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.

    Measured: 8 months

  6. Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint

    The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale is an scale that assesses the performance of daily tasks and activities. A lower score indicates lower functional performance.

    Measured: 8 months

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

    The Quality of Life in Alzheimer's Disease (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.

    Measured: 8 months

Secondary outcomes (3)

  1. Safety and tolerability of SPG302

    Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: 8 months

  2. Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)

    Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.

    Measured: 8 months

  3. Change in biomarkers 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: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start29 Jul 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427668
Sponsor's protocol ID
SPG302-ALZ-101
Status last verified
Aug 2025
First submitted
13 May 2024
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPG302 in people with Alzheimer 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 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint (time frame: 8 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06427668.

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 17 Aug 2025.

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