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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06427668
Registration number
NCT06427668
Ethics application status
Date submitted
13/05/2024
Date registered
24/05/2024
Date last updated
13/08/2024
Titles & IDs
Public title
Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)
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Scientific 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
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Secondary ID [1]
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SPG302-ALZ-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPG302
Treatment: Drugs - Placebo
Active comparator: Part A: Active SPG302 to be administered to adult participants with AD - 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.
Placebo comparator: Part A: Placebo comparator to be administered to adult participants with AD - 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.
Experimental: Part B: Expansion Cohort - Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A.
Treatment: Drugs: SPG302
synthetic small molecule
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint
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Assessment method [1]
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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.
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Timepoint [1]
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8 months
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Primary outcome [2]
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Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
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Assessment method [2]
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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.
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Timepoint [2]
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8 months
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Primary outcome [3]
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Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
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Assessment method [3]
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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.
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Timepoint [3]
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8 months
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Primary outcome [4]
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C-SSRS (Columbia Suicide Severity Rating Scale)
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Assessment method [4]
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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.
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Timepoint [4]
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8 months
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Primary outcome [5]
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Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
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Assessment method [5]
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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.
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Timepoint [5]
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8 months
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Primary outcome [6]
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Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint
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Assessment method [6]
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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.
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Timepoint [6]
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8 months
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Primary outcome [7]
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Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
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Assessment method [7]
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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.
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Timepoint [7]
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8 months
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Secondary outcome [1]
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Safety and tolerability of SPG302
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Assessment method [1]
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Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs)
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Timepoint [1]
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8 months
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Secondary outcome [2]
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Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)
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Assessment method [2]
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Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.
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Timepoint [2]
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8 months
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Secondary outcome [3]
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Change in biomarkers in participants with AD from baseline to endpoint.
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Assessment method [3]
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To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter.
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Timepoint [3]
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8 months
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Eligibility
Key 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
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Minimum age
45
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Flinders Medical center - Adelaide
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Spinogenix
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06427668
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lauren Priest, MBBS
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Address
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Flinders Medical Center, Adelaide, SA, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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info Spinogenix
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Address
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Country
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Phone
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+61 2 8382 4977
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06427668
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