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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)
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
Secondary ID [1] 0 0
SPG302-ALZ-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint
Timepoint [1] 0 0
8 months
Primary outcome [2] 0 0
Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
Timepoint [2] 0 0
8 months
Primary outcome [3] 0 0
Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
Timepoint [3] 0 0
8 months
Primary outcome [4] 0 0
C-SSRS (Columbia Suicide Severity Rating Scale)
Timepoint [4] 0 0
8 months
Primary outcome [5] 0 0
Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
Timepoint [5] 0 0
8 months
Primary outcome [6] 0 0
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint
Timepoint [6] 0 0
8 months
Primary outcome [7] 0 0
Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
Timepoint [7] 0 0
8 months
Secondary outcome [1] 0 0
Safety and tolerability of SPG302
Timepoint [1] 0 0
8 months
Secondary outcome [2] 0 0
Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)
Timepoint [2] 0 0
8 months
Secondary outcome [3] 0 0
Change in biomarkers in participants with AD from baseline to endpoint.
Timepoint [3] 0 0
8 months

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
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Flinders Medical center - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spinogenix
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06427668
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lauren Priest, MBBS
Address 0 0
Flinders Medical Center, Adelaide, SA, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
info Spinogenix
Address 0 0
Country 0 0
Phone 0 0
+61 2 8382 4977
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06427668