Phase 1
Completed N=16
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
Alzheimer's Disease · Alzheimer Disease (AD) · Alzheimers Disease Prevention
Source: ClinicalTrials.gov NCT06831812 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Safety and Tolerability of AV-1959R Compared to Placebo — 5; 1; 6; 2 Participants
Summary
This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60. Participants will receive three intramuscular injections of either adjuvanted AV-1959R (100 µg or 300 µg) or adjuvanted placebo at Weeks 0, 4, and 14, followed by an 8-week follow-up. Researchers will monitor for side effects and measure anti-Aβ antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of AV-1959R Compared to Placebo |
5; 1; 6; 2; 0; 0 | — |
| SECONDARY Immunogenicity of AV-1959R: Anti-Aβ Antibody Response |
71175; 126; 60439; 115 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female adults, 40-60 years old.
- BMI 18.0-32.0 kg/m².
- No significant medical conditions or abnormal MRI, ECG, or lab tests.
- Signed informed consent and ability to follow study procedures.
- Females must be postmenopausal or surgically sterile.
- Males must use contraception or be vasectomized.
Exclusion Criteria
- History of Alzheimer's, stroke, or neurodegenerative disease.
- MRI abnormalities, such as infarcts or microbleeds.
- Serious illness, surgery, or hospitalization in the last 4 weeks.
- Significant heart, lung, liver, kidney, or immune disorders.
- Recent drug/alcohol abuse or severe allergies.
- Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
- Use of investigational drugs or amyloid/tau therapies in the last year.
- Chronic use of immunosuppressants, anticoagulants, or blood products.
- Pregnant, breastfeeding, or women of childbearing potential.
- Recent blood donation (>400 mL) in the last 30 days.
Data sourced from ClinicalTrials.gov (NCT06831812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.