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CTAD POSTER 2019-1.Pdf The Journal of Prevention of Alzheimer’s Disease - JPAD© © Serdi and Springer Nature Switzerland AG 2019 Volume 6, Supplement 1, 2019 and memory. Third, we determined associations between demographic variables (gender, race, ethnicity, and education) POSTERS and registry participation (withdrawal and task completion) using logistic regression methods. Results: Of the 17,073 BHR Theme: CLINICAL TRIALS METHODOLOGY participants age 65+, 65% were female, 85% identified as Caucasian, 91% identified as non-Hispanic/Latino, and 68% had P001- UNDERREPRESENTED ELDERS IN THE BRAIN a bachelor’s degree or higher. Compared to the Census data, HEALTH REGISTRY: US REPRESENTATIVENESS the BHR underrepresented males (∆=-9.39%, p<.0001, V=0.003) AND REGISTRY BEHAVIOR. M.T. Ashford1,2,*, and Hispanic/Latino participants (∆=-5.81%, p<.0001, V=0.005). J. Eichenbaum1,2,3, T. Williams1,2,3, J. Fockler2,3, Non-Caucasians were also underrepresented (p<.0001, V=0.005), M. Camacho1,2, A. Ulbricht2,3, D. Flenniken1,2, specifically Black/African American participants (∆=-6.06%), D. Truran1,2, R.S. Mackin2,4, M.W. Weiner1,2,3, R.L. Nosheny2,4 Asian participants (∆=-2.35%), Native American and Alaska ((1) Northern California Institute for Research and Education Native participants (-0.31%), and participants from some other (NCIRE) - San Francisco (United States); (2) Department race (∆=-0.26%). Participants with lower education levels were of Veterans Affairs Medical Center, Center for Imaging also underrepresented (p<.0001, V=0.02), including those with and Neurodegenerative Diseases - San Francisco (United a community college degree or associate’s degree (∆=-1.37%), States); (3) Department of Radiology and Biomedical a high school degree (∆=-25.27%), or lower (∆=-15.26%). Only Imaging, University of California - San Francisco, USA; Native Hawaiian/Other Pacific Islander participants matched (4) Department of Psychiatry, University of California San Francisco - the US Census percentage. Rates of withdrawal from the BHR San Francisco (United States)) online study were the highest for Non-Hispanics/Latino (16.5%) and the lowest for Black/African American participants Backgrounds: The Many dementia-related registries and (3.4%). Non-Caucasian participants had lower withdrawal clinical trials are limited by a lack of representative samples, rates from the BHR study (OR=0.8, CI=0.64,0.99, p=.04). especially underserved groups (e.g. racial or ethnic groups, However, regarding task completion, Black/African American low socio-economic status). Reduced participation of participants (Core:45.3%, CBB:32.8%) and participants with less unrepresented groups in dementia-related research has serious than a high school education (Core:42.9%, CBB:27.0%) had the scientific and ethical ramifications. Online research registries lowest rates for completion of BHR self-report questionnaires offer the possibility to facilitate the recruitment of traditionally and CBB, compared to those with a bachelor’s degree or underrepresented groups into clinical research by remotely higher (Core:77.0%, CBB:59.9%) and Caucasian participants prescreening and referring to relevant clinical trials. However, (Core:74.5%, CBB:74.6%). Identifying as non-Hispanic/Latino little is currently known about the degree to which online and a higher education level was significantly associated with research registries are representative of the US population, completion of all four CBB tests (OR=1.23, CI=1.01,1.51, p=.04; and what factors are associated with participation. Objectives: OR=1.12, CI=1.1,1.13, p<.001), as well as completion of all The Brain Health Registry (BHR) is an online research registry core questionnaires (OR=1.33, CI=1.11,1.14, p<.001; OR=1.12, for recruitment, assessment, and longitudinal monitoring of CI=1.11,1.14, p<.001) at least once, respectively. The same currently over 66,000 participants, focusing on cognitive aging. significant associations were found for completing CBB and The first objective was to assess the extent to which older BHR core questionnaires at least twice. Identifying as non-Caucasian participants are representative of the US population of older was associated with lower completion of core questionnaires adults. The second objective was to assess associations between (OR=0.47, CI=0.42,0.52, p<.001) and CBB (OR=0.61, CI=0.55,0.68, race, ethnicity, and education and registry behaviors (task p<.001). Being female was significantly associated with completion and retention) in BHR. Methods: BHR participants completion of the core questionnaires (OR=1.2, CI=1.12,1.3, complete a series of online, unsupervised self-report p<.001). Conclusion: Older adult males, Hispanic/Latino, questionnaires and neuropsychological tests (e.g. the Cogstate Black/African American, Asian participants and especially Brief Battery (CBB)) every 6 months. This analysis focused on those with a lower educational status were underrepresented in US BHR participants aged 65 years or older and the following BHR compared to the US Census. This indicates that the BHR demographics: gender, race, ethnicity, and education. The reflects general participation biases present in most scientific US Census data from the 2017 American Community Survey research. Thus, there is a clear need to develop and evaluate was used to determine nationally representative percentage improved recruitment and engagement strategies to make estimates for the US population 65 years or older. First, to BHR more attractive to underrepresented groups (e.g. targeted assess overall differences in the BHR and the US Census in online advertising and tailoring the BHR website). Increasing terms of demographic variables of participants, the percentages registry diversity is important to increase the generalizability of individuals in our demographic categories were compared of results and applicability of findings to underserved and using Pearson’s Chi-squared test with Yates’ continuity underrepresented groups. Non-Caucasian race, non-Hispanic/ correction, and Cramer’s V was calculated as a measure of Latino ethnicity, and lower education were associated with strength of associations. Second, to determine registry decreased BHR task completion. However, being non-Caucasian participation, withdrawal and task completion rates for BHR was also associated with lower withdrawal rates. Future online questionnaires and CBB were calculated. Participants analyses need to determine whether covariates such as, for who communicated a desire to no longer participate in BHR example, age and subjective memory concern might account for were considered as withdrawn. The core battery of self-report any of these differences. questionnaires we considered included three questionnaires most commonly used for analysis (demographics, medical history, and initial). The CBB included four subtests that assess cognition across the domains of processing speed, attention, J Prev Alz Dis 2019;6(S1):S45-S154 Published online December 8, 2019, http://dx.doi.org/10.14283/jpad.2019.48 S45 P002- A PHASE 3- EFFICACY AND SAFETY STUDY up to Month 48. The Clinical Dementia Rating - Sum of Boxes PROTOCOL OF TRANEUROCIN (NA-831) IN (CDR-SB) scores ranging from 0 to 18. The CDR assesses 3 PARTICIPANTS WHO ARE ASYMPTOMATIC domains of cognition (memory, orientation, judgment/problem AT RISK FOR DEVELOPING ALZHEIMER’S solving) and 3 domains of function (community affairs, home/ DEMENTIA (PREVENTION). L. Tran, F. Vu, hobbies, personal care) using semi-structured interviews of S. Neave, B. Tran (NeuroActiva, Inc. - Moffett Filed, CA, (United both the study participant and an informant carried out by States)) a trained rater. The Higher CDR-SB scores indicate greater impairment. 5. Number of Participants With Adverse Events Background: Approximately The purpose of this study is (AEs) and Serious Adverse Events (SAEs) up to Month 48. An to evaluate whether treatment with Traneurocin (NA-831) AE was any untoward medical event that occurs in a participant slows cognitive decline compared with placebo treatment, as administered an investigational product, and it does not measured by a composite cognitive measure, the Preclinical necessarily indicate only events with clear causal relationship Alzheimer Cognitive Composite (PACC), in participants who with the relevant investigational product. An SAE was an are asymptomatic at risk for developing Alzheimer’s dementia. AE resulting in any of the following outcomes or deemed Traneurocin (NA-831) is an endogenous small molecule that significant for any other reason: death; initial or prolonged exhibits neuroprotection, neurogenesis, and cognitive protective inpatient hospitalization; life-threatening experience (immediate properties across a range of disease models. Phase 2 studies risk of dying); persistent or significant disability/incapacity; demonstrated that NA-831 was effective for improving congenital anomaly. Eligibility Criteria: Ages Eligible for cognitive and global functioning in patients with MCI and Study: 60 Years to 85 Years (Adult, Older Adult), Sexes mild and moderate Alzheimer’s disease over 24 weeks. The Eligible for Study: All. Accepts Healthy Volunteers: Yes. drug was well-tolerated taken orally at 30 mg per day. No Inclusion Criteria: · Participant must have a global Clinical adverse effects were observed. This is a randomized, double- Dementia Rating Scale- (CDR) score of ‘0’ at Screening; blind, multi-center, placebo-controlled, parallel-group study · Participants 60 to 64 years of age must also have either (a)
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