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NCT Number: NCT06427668

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Vincent's Hospital, Sydney, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPG302

Drug

synthetic small molecule

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 8 months

    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.

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

    Time frame: 8 months

    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.

  3. Change in Mini-Mental State Examination (MMSE) from baseline to endpoint

    Time frame: 8 months

    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.

  4. C-SSRS (Columbia Suicide Severity Rating Scale)

    Time frame: 8 months

    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.

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

    Time frame: 8 months

    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.

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

    Time frame: 8 months

    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.

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

    Time frame: 8 months

    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.

Secondary outcomes

  1. Safety and tolerability of SPG302

    Time frame: 8 months

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

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

    Time frame: 8 months

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

  3. Change in biomarkers in participants with AD from baseline to endpoint.

    Time frame: 8 months

    To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter.

Sponsors and collaborators

Lead sponsor

Spinogenix

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 24, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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