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Background Standardizing implementation of complex clinical outcome assessments (COAs) in Alzheimer’s disease (AD) clinical trials requires trained and qualified site raters. Best practices include setting minimum education and experience criteria, along with robust training programs. However, there is significant variability in the level of rigor applied to this process, often due to timeline and resource limitations. This study aimed to investigate the relation between raters’ experience and training performance and their in‐trial rater performance, as defined by remediations required during the trial. Method Data were analyzed from 160 raters across four AD clinical trials, including three countries and 70 sites. During startup, raters were categorized as fully qualified (via education, experience, and performance on applied scoring exercise) or sponsor exception (missing criteria but exempted into trial). Logistic regression was used to explore predictors of rater in‐trial performance (remediation during trial vs. no remediation). Predictors included 1) remediations during training, 2) rater qualification status, 3) AD clinical experience, and 4) AD research trial experience. Result Thirty‐eight (23.7%) of raters required remediation during trial. The average AD clinical experience was 108 months (SD=78 months), and average AD trials experience was 71 months (SD=52 months). Overall, the logistic regression model was significant c2 (4) = 20.6, p <.01, and remediation during training (B=1.91, SE=0.59, Wald=10.55, p <.001) and AD clinical experience (B= ‐0.01, SE=0.006, Wald = 6.68, p <.01) were significant predictors of remediation during trials. Conclusion These data confirm the importance of AD‐specific clinical experience and performance during pre‐trial training exercises as key indicators of rater performance during clinical trials. Sponsors should consider performance during pre‐trial startup activities when selecting raters to ensure that COAs are accurately scored and reliably implemented throughout the duration of the trial. Planned analyses will explore additional predictors of rater performance (e.g., individual and site level factors), as well as the implications of rater remediation on trial outcome data (i.e., impacts on data reliability).

Standardizing implementation of complex clinical outcome assessments (COAs) in Alzheimer's disease (AD) clinical trials requires trained and qualified site raters. Best practices include setting minimum education and experience criteria, along with robust training programs. However, there is significant variability in the level of rigor applied to this process, often due to timeline and resource limitations. This study aimed to investigate the relation between raters' experience and training performance and their in-trial rater performance, as defined by remediations required during the trial. Data were analyzed from 160 raters across four AD clinical trials, including three countries and 70 sites. During startup, raters were categorized as fully qualified (via education, experience, and performance on applied scoring exercise) or sponsor exception (missing criteria but exempted into trial). Logistic regression was used to explore predictors of rater in-trial performance (remediation during trial vs. no remediation). Predictors included 1) remediations during training, 2) rater qualification status, 3) AD clinical experience, and 4) AD research trial experience. Thirty-eight (23.7%) of raters required remediation during trial. The average AD clinical experience was 108 months (SD=78 months), and average AD trials experience was 71 months (SD=52 months). Overall, the logistic regression model was significant c (4) = 20.6, p <.01, and remediation during training (B=1.91, SE=0.59, Wald=10.55, p <.001) and AD clinical experience (B= -0.01, SE=0.006, Wald = 6.68, p <.01) were significant predictors of remediation during trials. These data confirm the importance of AD-specific clinical experience and performance during pre-trial training exercises as key indicators of rater performance during clinical trials. Sponsors should consider performance during pre-trial startup activities when selecting raters to ensure that COAs are accurately scored and reliably implemented throughout the duration of the trial. Planned analyses will explore additional predictors of rater performance (e.g., individual and site level factors), as well as the implications of rater remediation on trial outcome data (i.e., impacts on data reliability).

Background Informant reports are commonly regarded as reliable and supplemental alongside respondent cognitive assessments, particularly in low‐literacy settings with absent normative data. We evaluate the performance of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) in rural South Africa. Method This study utilizes data from the Cognition and Dementia in a Longitudinal Health and Aging Study in South Africa (HAALSI‐HCAP). The study population includes 1,029 unique informants of 676 paired participants across two survey waves. Among them, 475 participants followed in both waves and 124 of them had the same informants. A Shangaan‐translated 16‐item IQCODE was surveyed among informants. We examined IQCODE completeness and scores, tested the single latent concept assumption of IQCODE when applied to South Africa using factory analysis, and assessed IQCODE inter‐item reliability and convergent validity. We finally examined whether using a different informant affects IQCODE score using a linear regression. Analyses were replicated after excluding items with higher proportion of reporting ‘participant never do’. Result On average, informants aged 43.6 years and knew the paired participants for 32 years. Most informants were female (65%), participants’ children (48%), with above secondary degrees (45%), and lived with participants (66%). Informants averagely reported 0.9 items “participant never do”. Informants seeing participants daily versus those living together reported less “never do” items and give lower IQCODE score, controlling participants’ age, gender, and education. Children informants versus spouses tend to give higher IQCODE scores. Consistent with literature, IQCODE is a single concept with the first factor explaining 60% of total variance. IQCODE had excellent inter‐item reliability (Cronbach’s alpha = 0.94) and moderately correlated with participants’ recall memory scores. Using different informants does not affect IQCODE changes for the same participants over years. After excluding items with above 12% of informants reporting ‘participant never do’ (e.g., handling everyday arithmetic problems, financial matters, following a story, or learning new gadgets), results remained similar. Conclusion Informant characteristics affects IQCODE scores but not completeness. Changing informants between waves does not impact IQCODE score. With excellent reliability and good validity even upon excluding several items, IQCODE is useful for assessing dementia among South African older adults.

BackgroundThe relationship between subjective social position (SSP) and cognitive ageing unclear, especially in low-income settings. We aimed to investigate the relationship between SSP and cognitive function over time among older adults in rural South Africa.MethodsData were from 3771 adults aged ≥40 in the population-representative ‘Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa’ from 2014/2015 (baseline) to 2018/2019 (follow-up). SSP was assessed at baseline with the 10-rung MacArthur Network social position ladder. Outcomes were composite orientation and episodic memory scores at baseline and follow-up (range: 0–24). Mortality- and attrition-weighted linear regression estimated the associations between baseline SSP with cognitive scores at each of the baseline and follow-up. Models were adjusted for age, age2, sex, country of birth, father’s occupation, education, employment, household assets, literacy, marital status and health-related covariates.ResultsSSP responses ranged from 0 (bottom ladder rung/lowest social position) to 10 (top ladder rung/highest social position), with a mean of 6.6 (SD: 2.3). SSP was positively associated with baseline cognitive score (adjusted β=0.198 points per ladder rung increase; 95% CI 0.145 to 0.253) and follow-up cognitive score (adjusted β=0.078 points per ladder rung increase; 95% CI 0.021 to 0.136).ConclusionIndependent of objective socioeconomic position measures, SSP is associated with orientation and episodic memory scores over two time points approximately 3 years apart among older rural South Africans. Future research is needed to establish the causality of the observed relationships, whether they persist over longer follow-up periods and their consistency in other populations.

Dementia criteria require not only memory impairment, but additional impairment in at least one other cognitive domain, like visuospatial functioning. Cognitive measures assessing visuospatial function often involve drawing shapes. While these measures have proven reliable and valid in developed countries, their use in Low and Middle-income Countries (LMICs) is challenging due to cultural differences and low literacy. Cultural and educational bias in visuospatial tests prevents comprehensive assessment of neuropsychological function, thus limiting dementia assessment in LMICs. Here, we compare the Stick Design Test (SDT) to Constructional Praxis (CP) for assessing visuospatial functioning among older South Africans adults. We used data from Cognition and Dementia in the Health and Aging in Africa: A Longitudinal Study in South Africa (HAALSI-HCAP), a population-based nested cohort study in rural Agincourt, South Africa. In 2022, 675 participants, aged ≥ 50, were administered the immediate and delayed recall trials of the SDT and CP, as part of HAALSI-HCAP cognitive battery. CP, completed on a tablet, involved copying four geometric shapes, while SDT required participants to reconstruct four configurations using matchsticks. Scoring for both CP (0-11) and SDT (0-12) was subsequently completed by trained researchers. We assessed acceptability and performance of both measures across participant demographics and investigated their correlation with performance on other visuospatial measures to ascertain criterion validity. Participants were mostly women (63%), without education (58%) with mean age of 72.5±11. Refusals and missingness were more common for CP (40%) than SDT (13%). SDT had a more normal distribution compared to CP, overall and for individual figures. Worse performance was associated with higher age and lack of formal education for both measures. However, SDT demonstrated less extreme z-standardized scores, particularly among those without education and over 70 years old. Participants were more likely to recall SDT configurations than CP figures after a delay. SDT showed weak but significant correlations (p<0.001) with CP(r = 0.14), Raven's Matrices(r = 0.27), and Symbol Cancellation (r = 0.38). SDT outperformed CP in acceptability and demonstrated lower sensitivity to education. Convergent validity findings suggest that SDT may be a robust and culturally adaptable measure for assessing visuospatial functioning in older populations, especially in low-resource settings.

People with Alzheimer's Disease (AD) often have neuropsychiatric symptoms. The Neuropsychiatric Inventory (NPI) is a validated tool for assessing the severity of these symptoms, but its applicability in a South African context remains unexamined. This study evaluated NPI-Q, a brief version of the NPI, in relation to cognitive performance and markers of brain atrophy and emotional regulation among older South African adults. Data were from Cognition and Dementia in the Health and Aging in Africa: A Longitudinal Study in South Africa (HAALSI-HCAP), a population-based nested cohort study in Agincourt, South Africa. The survey included a cognitive battery, clinical examination, and informant interview to assess perceived cognitive and functional changes in respondents. During the informant interview, the NPI-Q was completed, and a severity score was derived from the cumulative sum of reported individual symptom scores (range: 0-36). The final sample included 626 participants (71.9±11.3 years-old, 35.6% men, 56.6% without formal education), of whom 185 underwent MRI scans. Pairwise correlations assessed the relationship between informant reported symptom severity with cognitive measures and MRI-generated bilateral amygdala volume. A total of 95 informants (15.2%) reported any neuropsychiatric symptoms, averaging 2.48 per participant among those who reported any symptom. Hallucinations were the most common symptom (5.4%), while disinhibition was the least (1%). Among those who reported symptoms, average symptom severity score was 4.28 (SD: 3.65). Severity was significantly correlated (p-value<0.001) with most cognitive measures assessing general cognition (β: -0.27, -0.17), episodic memory (β: -0.26, -0.17), language (β: -0.28, -0.12), and executive function (β: -0.26, -0.12). However, no relationship was observed between neuropsychiatric symptoms and visuospatial functioning or amygdala volume, possibly attributable to high rate of missingness for visuospatial measures (30%), and the small MRI sample size reporting symptoms (n = 26). NPI-Q symptoms were associated with lower cognitive performance, revealing a significant relationship between symptom severity and cognitive performance across all measures of the HAALSI-HCAP cognitive battery, except for those evaluating visuospatial function. Associations between neuropsychiatric symptoms and bilateral amygdala volume were less evident. These results contribute to understanding the impact of neuropsychiatric symptoms on cognitive health in aging South African populations.

Background People with Alzheimer’s Disease (AD) often have neuropsychiatric symptoms. The Neuropsychiatric Inventory (NPI) is a validated tool for assessing the severity of these symptoms, but its applicability in a South African context remains unexamined. This study evaluated NPI‐Q, a brief version of the NPI, in relation to cognitive performance and markers of brain atrophy and emotional regulation among older South African adults. Method Data were from Cognition and Dementia in the Health and Aging in Africa: A Longitudinal Study in South Africa (HAALSI‐HCAP), a population‐based nested cohort study in Agincourt, South Africa. The survey included a cognitive battery, clinical examination, and informant interview to assess perceived cognitive and functional changes in respondents. During the informant interview, the NPI‐Q was completed, and a severity score was derived from the cumulative sum of reported individual symptom scores (range: 0‐36). The final sample included 626 participants (71.9±11.3 years‐old, 35.6% men, 56.6% without formal education), of whom 185 underwent MRI scans. Pairwise correlations assessed the relationship between informant reported symptom severity with cognitive measures and MRI‐generated bilateral amygdala volume. Result A total of 95 informants (15.2%) reported any neuropsychiatric symptoms, averaging 2.48 per participant among those who reported any symptom. Hallucinations were the most common symptom (5.4%), while disinhibition was the least (1%). Among those who reported symptoms, average symptom severity score was 4.28 (SD: 3.65). Severity was significantly correlated (p‐value<0.001) with most cognitive measures assessing general cognition (β: ‐0.27, ‐0.17), episodic memory (β: ‐0.26, ‐0.17), language (β: ‐0.28, ‐0.12), and executive function (β: ‐0.26, ‐0.12). However, no relationship was observed between neuropsychiatric symptoms and visuospatial functioning or amygdala volume, possibly attributable to high rate of missingness for visuospatial measures (30%), and the small MRI sample size reporting symptoms (n = 26). Conclusion NPI‐Q symptoms were associated with lower cognitive performance, revealing a significant relationship between symptom severity and cognitive performance across all measures of the HAALSI‐HCAP cognitive battery, except for those evaluating visuospatial function. Associations between neuropsychiatric symptoms and bilateral amygdala volume were less evident. These results contribute to understanding the impact of neuropsychiatric symptoms on cognitive health in aging South African populations.

Background Dementia criteria require not only memory impairment, but additional impairment in at least one other cognitive domain, like visuospatial functioning. Cognitive measures assessing visuospatial function often involve drawing shapes. While these measures have proven reliable and valid in developed countries, their use in Low and Middle‐income Countries (LMICs) is challenging due to cultural differences and low literacy. Cultural and educational bias in visuospatial tests prevents comprehensive assessment of neuropsychological function, thus limiting dementia assessment in LMICs. Here, we compare the Stick Design Test (SDT) to Constructional Praxis (CP) for assessing visuospatial functioning among older South Africans adults. Method We used data from Cognition and Dementia in the Health and Aging in Africa: A Longitudinal Study in South Africa (HAALSI‐HCAP), a population‐based nested cohort study in rural Agincourt, South Africa. In 2022, 675 participants, aged ≥ 50, were administered the immediate and delayed recall trials of the SDT and CP, as part of HAALSI‐HCAP cognitive battery. CP, completed on a tablet, involved copying four geometric shapes, while SDT required participants to reconstruct four configurations using matchsticks. Scoring for both CP (0‐11) and SDT (0‐12) was subsequently completed by trained researchers. We assessed acceptability and performance of both measures across participant demographics and investigated their correlation with performance on other visuospatial measures to ascertain criterion validity. Result Participants were mostly women (63%), without education (58%) with mean age of 72.5±11. Refusals and missingness were more common for CP (40%) than SDT (13%). SDT had a more normal distribution compared to CP, overall and for individual figures. Worse performance was associated with higher age and lack of formal education for both measures. However, SDT demonstrated less extreme z‐standardized scores, particularly among those without education and over 70 years old. Participants were more likely to recall SDT configurations than CP figures after a delay. SDT showed weak but significant correlations (p<0.001) with CP(r = 0.14), Raven’s Matrices(r = 0.27), and Symbol Cancellation (r = 0.38). Conclusion SDT outperformed CP in acceptability and demonstrated lower sensitivity to education. Convergent validity findings suggest that SDT may be a robust and culturally adaptable measure for assessing visuospatial functioning in older populations, especially in low‐resource settings.

INTRODUCTION The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) is suitable for screening dementia, particularly in populations with limited education. However, its feasibility and psychometrics in South Africa remain unassessed. METHODS We analyzed 1309 index participant–informant dyads from the Health and Aging in Africa: Longitudinal Study of an International Network for the Demographic Evaluation of Populations and Their Health Community in South Africa study in rural South Africa, assessing IQCODE completeness, associations with index participant/informant characteristics, single‐factor structure and reliability via factor analysis, and validity through correlations with neuropsychological tests. RESULTS Index participants averaged 71.9 years, with > 50% lacking formal education. IQCODE missingness declined across waves and was associated with index participant characteristics. IQCODE scores were correlated with both index participant and informant characteristics. The 16‐item IQCODE demonstrated a single‐factor structure explaining up to 66% of variance, strong internal consistency, and correlations with word and story recall, indicating high convergent validity. DISCUSSION IQCODE is a reliable, valid dementia assessment tool in rural South Africa, supporting broader African applications and cross‐national comparisons. Highlights Sixteen‐item Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) responses in rural South Africa support a single‐factor construct, explaining up to 66% of total observed variance. The single‐factor structure is reliable, as the IQCODE items data show high internal consistency (omega hierarchical = 0.90). The IQCODE score shows strong convergent validity with significant correlation with word and story recall memory measures. Index participants’ characteristics are mainly associated with IQCODE completion. IQCODE contributes to dementia assessment in rural South Africa and other settings with low education populations.

INTRODUCTION South Africa faces growing dementia challenges, worsened by limited medical resources and low education. Modifiable risk factors like hearing and vision impairments remain understudied despite their high prevalence. METHODS We analyzed data from 567 participants in a rural South African cohort to examine the associations between vision and hearing impairment, and dementia outcomes. Multinomial logistic regression assessed associations between sensory impairments (distance vision, near vision, hearing) and mild cognitive impairment (MCI) or dementia. Linear regression examined sensory impairment and predicted dementia probability score 2 years later. RESULTS Half of the participants were over 70, with no formal education. Sensory impairments were common, especially in dementia cases. Distance vision impairment was linked to both MCI and dementia, while near vision and hearing impairments were associated with dementia. Hearing impairment also predicted higher dementia probability after 2 years. DISCUSSION Addressing sensory impairments is key to dementia prevention in rural South Africa. HIGHLIGHTS Among rural older South Africans, 65% had near vision impairment and 47% had hearing impairment. Distance or near vision and hearing impairments are linked to an increased risk of dementia. Distance vision impairment is also associated with a higher risk of mild cognitive impairment (MCI). Dementia risk was seven times higher with distance vision, near vision and hearing impairment. Hearing impairment increased the probability of dementia 2 years later in initially non‐demented individuals.