A Phase I, Randomized, Double-Blind Study to Evaluate Safety and Tolerability of Amyloid-β Vaccine, AV-1959D, in Patients With Early Alzheimer's Disease.

Official Summary

Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: SEQUENTIAL
• Masking: TRIPLE
• Enrollment: 48 participants

Interventions

• BIOLOGICAL: AV-1959D — Three doses of AV-1959D administered as a sterile suspension via intradermal injection
• BIOLOGICAL: Placebo — Three doses of Placebo administered as a sterile suspension via intradermal injection

Primary Outcomes

• Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) (Baseline up to Week 28 weeks)

Secondary Outcomes

• Number of participants with clinically significant changes in vital signs (Baseline up to Week 28)
• Number of participants with clinically significant changes in ECG results (Baseline up to Week 28)
• Number of participants with clinically significant changes in laboratory test (Baseline up to Week 28)
• Number of participants with clinically significant changes in physical examinations (Screening up to Week 28)
• Number of participants with clinically significant changes in neurological examinations (Screening up to Week 28)

Trial Locations

• Banner Alzheimer's Institute, Phoenix, Arizona, United States
• Hoag Memorial Hospital, Newport Beach, California, United States
• University of South Florida, Tampa, Florida, United States
• Alzheimer's Research and Treatment Center, Wellington, Florida, United States
• Accel Research, Decatur, Georgia, United States
• Global Medical Institutes Princeton Medical Institute, Princeton, New Jersey, United States

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