Extension Study of Participants From SPG302-ALZ-101 (NCT06833281) | Clinical Trial Compass
TerminatedPhase 2
Extension Study of Participants From SPG302-ALZ-101
Stopped: patients treated on compassionate use program
Australia12 participantsStarted 2025-03-25
Plain-language 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)
Who can participate
Age range45 Years – 85 Years
SexALL
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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
What they're measuring
1
Treatment emergent adverse events and serious adverse events