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Kwok (Shalin, Hong Kong) J.-T. Yu (Qingdao, China) Y. Lee (Suwon, Republic of Korea) Instruction for Authors available at the journal website (www.editorialmanager.com/jpad) ISSN 2274-5807 This journal is printed on acid-free paper JPAD The Journal of Prevention of Alzheimer’s Disease© - Volume 7, Supplement 1, 2020 The Journal of Prevention of Alzheimer’s Disease - JPAD Volume 7, Supplement 1, 2020 Contents The Journal of Prevention of Alzheimer’s Disease JPAD Volume 7, Supplement 1, 2020 Supplement: 13th Conference Clinical Trials Alzheimer’s Disease, November 4-7, 2020 S2 • Symposia - Oral Communications - Late Breaking News S55 • Posters S1 The Journal of Prevention of Alzheimer’s Disease - JPAD © Serdi and Springer Nature Switzerland AG 2020 Volume 7, Supplement 1, 2020 studies in small mammals, baboons, and macaques showed SYMPOSIA that UB-311 generated antibody responses, cleared insoluble amyloid and reduced amyloid toxicity. A Ph1 safety, S1- DEVELOPMENT OF A VACCINE FOR PREVENTION tolerability, and immunogenicity trial demonstrated that UB-311 AND TREATMENT OF ALZHEIMER’S DISEASE. S. 1 2 3 4 was safe, well-tolerated, and produced a specific antibody Hendrix , C. Jeffrey , R. Eric , M. Richard ((1) Pentara - Millcreek, response in all participants tested. A Ph2 trial included 45 USA; (2) Cns Innovations - Las Vegas; USA; (3) Banner Alzheimer’s patients at four sites; participants had a 97% immunologic Institute - Phoenix, USA; (4) Global Alzheimer’s Platform Foundation response rate. All secondary endpoints - including Amyloid - Washington Dc, USA) PET burden, CDR-SB, ADCS-ADL, ADAS-Cog and MMSE - Presentation 1: Past and current vaccine and immunotherapy pointed directionally in favor of UB-311. The most common development in Alzheimer’s disease adverse events were injection site-related reactions and asymptomatic ARIA-H. UB-311 is being advanced to Ph3 Developing vaccines for the treatment of Alzheimer’s disease in a randomized, double-blind, placebo-controlled study to poses unique challenges. Success for a vaccine approach aimed assess the efficacy, safety, and tolerability in participants with at endogenous targets relies on the ability to break immune mild AD dementia or MCI due to AD. Eligible participants tolerance and generate a humoral antibody response against will be 60-85 years old, have MMSE of 20-26, CDR global the desired epitopes. AN1792 was created using a synthetic scores of 0.5 or 1, and International Shopping List Test scores full-length Aβ1-42 peptide. Nineteen percent of patients in 1 standard deviation below the mean or greater, and positive the trial generated anti-Aβ antibody responses and showed amyloid imaging. The primary outcome measure is the CDR- improved memory and decreased levels of tau protein in the SB difference in change from baseline in the active treatment CSF. Postmortem pathology examination of former AN1792 groups vs placebo at week 73. Secondary outcomes include patients showed that the vaccine had markedly cleared ADAS-Cog 13 item, Amsterdam Instrumental Activities of Daily plaques from the brain. Vaccine candidates such as CAD106 Living Questionnaire, AD Composite Score (ADCOMS), MMSE, and UB-311 use selective epitopes and were developed to and safety and tolerability of UB 311. Biomarker outcomes avoid the undesirable inflammatory effects that were seen include NfL, p-tau, tau, amyloid PET, CSF (subgroup) and with AN1792. Studies of recent and current amyloid targeting plasma Aβ40 and Aβ42, and hippocampal and whole brain immunotherapies (18 therapeutics) and vaccine therapeutics volume as measured by MRI. The relationship between the (8) illustrate lessons learned regarding patient selection, clinical primary and biomarker outcomes will be assessed. and biomarker outcomes, dosing regimens and assessment of antibody response. A meta-analysis of 13 RCT of amyloid- Presentation 3: The promise of blood-based biomarkers in the based immunotherapies in AD showed statistically significant evaluation, approval and affordability in Alzheimer’s prevention improvement in ADAS-cog (p<0.01) on drug. Solanezumab therapies and AN1792 showed the largest effect sizes and safest profiles, but the rates of ARIA-E were significantly higher with Blood-based biomarkers (BBBs) have the potential to monoclonal antibodies. Positive ADAS-cog effect sizes were transform Alzheimer’s research, treatment and care. I will seen for AN1792, Solanezumab EXPEDITION 3, BAN2401 and note several promising BBB’s, suggest how they could Aducanumab ENGAGE. Earlier EXPEDITION studies also inform treatment development, accelerate the evaluation included moderate disease, with substantially lower effect sizes. and approval of vaccines and other prevention therapies,