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

NCT06427668 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SPG302-ALZ-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; synapse; neural connectivity; Dementia

Outcome Measures

Primary Outcomes (7)

• 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.

  8 months

• 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.

  8 months

• 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.

  8 months

• 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.

  8 months

• 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.

  8 months

• 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.

  8 months

• 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.

  8 months

Secondary Outcomes (3)

• Safety and tolerability of SPG302

  8 months

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

  8 months

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

  8 months

Study Arms (3)

Part A: Active SPG302 to be administered to adult participants with AD

ACTIVE COMPARATOR

Cohort 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.

Drug: SPG302

Part A: Placebo comparator to be administered to adult participants with AD

PLACEBO COMPARATOR

Cohort 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.

Drug: Placebo

Part B: Expansion Cohort

EXPERIMENTAL

Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A.

Drug: SPG302

Interventions

SPG302 DRUG

synthetic small molecule

Part A: Active SPG302 to be administered to adult participants with AD; Part B: Expansion Cohort

Placebo DRUG

Placebo

Part A: Placebo comparator to be administered to adult participants with AD

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spinogenix: lead

Study Sites (2)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Flinders Medical center

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lauren Priest, MBBS

  Flinders Medical Center, Adelaide, SA, Australia

  PRINCIPAL INVESTIGATOR

• Brew Brew, MBBS,MD,DSC

  St Vincents Hospital, Sydney, NSW, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 24, 2024
• Study Start: July 29, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

AU (2)