Evaluating SPG302 for adults with mild-to-moderate Alzheimer's disease
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 study is testing a new drug called SPG302 to see if it can safely help adults with mild-to-moderate Alzheimer's disease improve their thinking and brain function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Spinogenix Industry-sponsored |
| Locations | 2 sites (Sydney, New South Wales and 1 other locations) |
| Trial ID | NCT06427668 on ClinicalTrials.gov |
What this trial studies
This phase 2 study aims to assess the safety, tolerability, and clinical efficacy of SPG302 in adults diagnosed with mild-to-moderate Alzheimer's disease. The study is divided into two parts: the first part is a placebo-controlled, randomized cohort that will involve daily dosing for 28-day cycles, while the second part is a randomized expansion cohort also involving daily dosing for 28-day cycles. Participants will be monitored for pharmacokinetics and pharmacodynamics to evaluate the drug's effects on cognitive function and neural connectivity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 45-85 with a diagnosis of mild to moderate Alzheimer's disease.
Not a fit: Patients with severe Alzheimer's disease or those with significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with mild-to-moderate Alzheimer's disease.
How similar studies have performed: Other studies targeting Alzheimer's disease with similar approaches have shown promise, but this specific intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Sydney, New South Wales and 1 other locations
- St Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
- Flinders Medical center — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Principal investigator: Lauren Priest, MBBS — Flinders Medical Center, Adelaide, SA, Australia
- Study coordinator: info Spinogenix
- Email: info@spinogenix.com
- Phone: +61 2 8382 4977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.