Clinical trial NCT06833281: Extension Study of Participants From SPG302-ALZ-101
Official title: An Open-label Extension of SPG302-ALZ-101 Study to Evaluate the Long-term Safety and Efficacy of Daily Oral SPG302 Treatment in Participants With Mild-to-Moderate Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
synapse
neural connectivity
Lead sponsor: Spinogenix
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label extension
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALZ-101 with mild to moderate Alzheimer's Disease (AD)

Detailed description: This is an open-label extension study of SPG302-ALZ-101 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with mild-to-moderate AD. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate AD
* Clinical laboratory values within normal range or \< 1.5 times ULN
* Life expectancy of \>2 years
* Able and willing to provide written informed consent
* Must have participated in all study activities of SPG302-ALZ-101, the parent study

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

Primary outcomes:
measure: Treatment emergent adverse events and serious adverse events
timeFrame: Up to 52 weeks
measure: C-SSRS (Columbia Suicide Severity Rating Scale)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
timeFrame: up to 52 weeks
measure: Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
timeFrame: up to 52 weeks
measure: Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
timeFrame: up to 52 weeks
measure: Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
timeFrame: up to 52 weeks
measure: Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint
timeFrame: up to 52 weeks
measure: Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.
timeFrame: up to 52 weeks
measure: Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Flinders Medical Center
state: South Australia
Study officials:
affiliation: Flinders Medical Center, Adelaide, SA, Australia
name: Lauren Priest, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincents Hospital, Sydney, NSW, Australia
name: Brew Brew, MBBS, MD, DSC
role: PRINCIPAL_INVESTIGATOR
References: