Extension Study of Participants From SPG302-ALZ-101
Reason given: patients treated on compassionate use program
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
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Trial details
- Who runs it
- Spinogenix
- Trial code
- NCT06833281
- Record updated
- 18 December 2025
- Original description
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)Read full original descriptionShow less
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)
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)
Inclusion: 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: Vaccines within 14 days; Receipt of investigational products within 30 days; 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; Blood donation within 30 days; Pregnant or breastfeeding.