INS NYC 2024 Program

Poster	Poster Session 02 Program Schedule 02/15/2024 08:00 am - 09:15 am Room: Majestic Complex (Posters 61-120) Poster Session 02: Aging \| MCI \| Neurodegenerative Disease - PART 1 Final Abstract #68 Simulated Alzheimer Clinical Trial Enrollment: Which Criteria Hinder Diverse Participants? Stacey Moeller, University of Nevada, Las Vegas, Las Vegas, United States Samantha John, University of Nevada, Las Vegas, Las Vegas, United States Category: Dementia (Alzheimer's Disease) Keyword 1: diversity Keyword 2: clinical trials Keyword 3: inclusion Objective: Ethnoracially diverse recruitment for Alzheimer’s disease (AD) clinical trials remains low, with many researchers blaming restrictive study inclusion criteria. Many ethnoracially minoritized individuals do not differ in their willingness to participate in research, and therefore other factors limiting recruitment should be explored. To examine the effects of inclusion/exclusion criteria on ethnoracial groups, this study applied criteria from the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study to existing participants in the National Alzheimer's Coordinating Center (NACC). Participants and Methods: The NACC includes data from 37 Alzheimer’s disease research centers; each site collects longitudinal medical, neurological, and neuropsychological variables, and neuroimaging and biomarker data, as available. Inclusion criteria for the NACC study are broad and each site prioritizes specific populations; all sites require a study partner. Baseline data were identified for 1,484 multiracial, 1,305 Asian, 6,106 Black/African American (B/AA), 2,641 Hispanic/Latino white (HLW), and 34,937 non-Hispanic white (NHW) participants. A4 inclusion and exclusion criteria were systematically applied to this cohort to determine their impact on eligibility. A4 required: a study partner, Mini-Mental State Examination (MMSE) of 25-30, Logical Memory (LM) delayed recall of 6-18, Clinical Dementia Rating (CDR) global score of 0, and to be aged 65-85. Commensurate NACC variables for A4 exclusion criteria were identified. Exclusion criteria, which cover 10 different characteristics, were grouped into cardiovascular, neurological, and mental health categories, and included variables like pacemaker usage, positive seizure history, and recent depression history, respectively. After inclusion criteria were applied, remaining participants were screened for exclusion criteria in a stepwise pattern. A chi-square test was used to compare the proportions of each ethnoracial group that were lost/retained after application of criteria. Results: After applying inclusion criteria, only 206 (13.88%) multiracial, 125 (9.58%) Asian, 1,038 (17.0%) B/AA, 267 (10.11%) HLW, and 5,214 (14.92%) NHW participants remained. After applying cardiovascular variables, 179 (12.06%) multiracial, 100 (7.66%) Asian, 921 (15.08%) B/AA, 235 (8.90%) HLW, and 4,344 (12.43%) NHW participants remained. After applying neurological variables, 162 (10.92%) multiracial, 95 (7.28%) Asian, 841 (13.77%) B/AA, 220 (8.33%) HLW, and 3,969 (11.36%) NHW participants remained. All cases with active depression in the past 2 years were then excluded, resulting in 140 (9.43%) multiracial, 86 (6.59%) Asian, 764 (12.51%) B/AA, 175 (6.63%) HLW, and 3,305 (9.46%) NHW potential participants. Inclusion criteria as a whole (and LM specifically) were the most prohibitive for theoretical study involvement for all ethnoracial groups. A chi-square test indicated a significant relationship between ethnoracial group and remaining sample proportions after application of inclusion criteria, X² (4, N = 46,134) = 95.38, p <.001), such that multiracial, Asian, and HLW participants were less likely to meet inclusion criteria than B/AA and NHW participants. Conclusions: While this study only simulated the A4 screening process and has its limitations, it demonstrates the impact of study criteria on theoretical prospective participants who have already demonstrated that they are amenable and able to participate in research. This highlights the need for study investigators to critically evaluate methodological decisions made in study design and their impact on prospective participants, especially ethnoracially diverse individuals.

Poster

02/15/2024
08:00 am - 09:15 am
Room: Majestic Complex (Posters 61-120)

Poster Session 02: Aging | MCI | Neurodegenerative Disease - PART 1

Final Abstract #68

Simulated Alzheimer Clinical Trial Enrollment: Which Criteria Hinder Diverse Participants?

Stacey Moeller, University of Nevada, Las Vegas, Las Vegas, United States
Samantha John, University of Nevada, Las Vegas, Las Vegas, United States

Category: Dementia (Alzheimer's Disease)

Keyword 1: diversity
Keyword 2: clinical trials
Keyword 3: inclusion

Objective:

Ethnoracially diverse recruitment for Alzheimer’s disease (AD) clinical trials remains low, with many researchers blaming restrictive study inclusion criteria. Many ethnoracially minoritized individuals do not differ in their willingness to participate in research, and therefore other factors limiting recruitment should be explored. To examine the effects of inclusion/exclusion criteria on ethnoracial groups, this study applied criteria from the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study to existing participants in the National Alzheimer's Coordinating Center (NACC).

Participants and Methods:

The NACC includes data from 37 Alzheimer’s disease research centers; each site collects longitudinal medical, neurological, and neuropsychological variables, and neuroimaging and biomarker data, as available. Inclusion criteria for the NACC study are broad and each site prioritizes specific populations; all sites require a study partner. Baseline data were identified for 1,484 multiracial, 1,305 Asian, 6,106 Black/African American (B/AA), 2,641 Hispanic/Latino white (HLW), and 34,937 non-Hispanic white (NHW) participants. A4 inclusion and exclusion criteria were systematically applied to this cohort to determine their impact on eligibility. A4 required: a study partner, Mini-Mental State Examination (MMSE) of 25-30, Logical Memory (LM) delayed recall of 6-18, Clinical Dementia Rating (CDR) global score of 0, and to be aged 65-85. Commensurate NACC variables for A4 exclusion criteria were identified. Exclusion criteria, which cover 10 different characteristics, were grouped into cardiovascular, neurological, and mental health categories, and included variables like pacemaker usage, positive seizure history, and recent depression history, respectively. After inclusion criteria were applied, remaining participants were screened for exclusion criteria in a stepwise pattern. A chi-square test was used to compare the proportions of each ethnoracial group that were lost/retained after application of criteria.

Results:

After applying inclusion criteria, only 206 (13.88%) multiracial, 125 (9.58%) Asian, 1,038 (17.0%) B/AA, 267 (10.11%) HLW, and 5,214 (14.92%) NHW participants remained. After applying cardiovascular variables, 179 (12.06%) multiracial, 100 (7.66%) Asian, 921 (15.08%) B/AA, 235 (8.90%) HLW, and 4,344 (12.43%) NHW participants remained. After applying neurological variables, 162 (10.92%) multiracial, 95 (7.28%) Asian, 841 (13.77%) B/AA, 220 (8.33%) HLW, and 3,969 (11.36%) NHW participants remained. All cases with active depression in the past 2 years were then excluded, resulting in 140 (9.43%) multiracial, 86 (6.59%) Asian, 764 (12.51%) B/AA, 175 (6.63%) HLW, and 3,305 (9.46%) NHW potential participants. Inclusion criteria as a whole (and LM specifically) were the most prohibitive for theoretical study involvement for all ethnoracial groups. A chi-square test indicated a significant relationship between ethnoracial group and remaining sample proportions after application of inclusion criteria, X² (4, N = 46,134) = 95.38, p <.001), such that multiracial, Asian, and HLW participants were less likely to meet inclusion criteria than B/AA and NHW participants.

Conclusions:

While this study only simulated the A4 screening process and has its limitations, it demonstrates the impact of study criteria on theoretical prospective participants who have already demonstrated that they are amenable and able to participate in research. This highlights the need for study investigators to critically evaluate methodological decisions made in study design and their impact on prospective participants, especially ethnoracially diverse individuals.