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

Last updated: August 12, 2024
Sponsor: Spinogenix
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

SPG302

Clinical Study ID

NCT06427668
SPG302-ALZ-101
  • Ages 45-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 tofirst dose of study drug.

  • Life expectancy of >2 years

  • Able and willing to provide written informed consent

Exclusion

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

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 29, 2024
Estimated Completion Date:
June 30, 2026

Study 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

Connect with a study center

  • St Vincent's Hospital

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Flinders Medical center

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

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