Recruitment methods and yield rates for a multisite clinical trial exploring risk reduction for Alzheimer's disease (rrAD).

INTRODUCTION: The risk reduction for Alzheimer's disease (rrAD) trial was a multisite clinical trial to assess exercise and intensive vascular pharmacological treatment on cognitive function in community-dwelling older adults at increased risk for Alzheimer's disease. METHODS: Eligibility, consent, and randomization rates across different referral sources were compared. Informal interviews conducted with each site's project team were conducted upon study completion. RESULTS: Initially, 3290 individuals were screened, of whom 28% were eligible to consent, 805 consented to participate (87.2% of those eligible), and 513 (36.3% of those consented) were randomized. Emails sent from study site listservs/databases yielded the highest amount (20.9%) of screened individuals. Professional referrals from physicians yielded the greatest percentage of consented individuals (57.1%). Referrals from non-professional contacts (ie, friends, family; 75%) and mail/phone contact from a site (73.8%) had the highest yield of randomization. DISCUSSION: Professional referrals or email from listservs/registries were most effective for enrolling participants. The greatest yield of eligible/randomized participants came from non-professional and mail/phone contacts. Future trials should consider special efforts targeting these recruitment approaches. Highlights: Clinical trial recruitment is commonly cited as a significant barrier to advancing our understanding of cognitive health interventions.The most cited referral source was email, followed by interviews/editorials on the radio, television, local newspapers, newsletters, or magazine articles.The referral method that brought in the largest number of contacts was email but did not result in the greatest yield of consents or eligible participants.The sources that yielded the greatest likelihood of consent were professional referrals (ie, physician), social media, and mail/phone contact from study site.The greatest yield of eligible/randomized participants came from non-professional contacts and mail/phone contact from a site.Findings suggest that sites may need to focus on more selective referral sources, such as using contact mailing and phone lists, rather than more widely viewed recruitment sources, such as social media or TV/radio advertisements.

Safety and Tolerability of Whole Soybean Products: A Dose-Escalating Clinical Trial in Older Adults with Obesity.

Soybean products have nutrients, dietary fiber, and phytoalexins beneficial for cardiovascular and overall health. Despite their high consumption in Asian populations, their safety in Western diets is debated. We conducted a dose-escalating clinical trial of the safety and tolerability of soybean products in eight older adults (70-85 years) with obesity. Whole green soybean pods grown under controlled conditions were processed to flour (WGS) at the United States Department of Agriculture using common cooking techniques such as slicing and heat treatment. WGS incorporated into food products was consumed at 10 g, 20 g, and 30 g/day for one week at each dose. The gastrointestinal outcomes, clinical biomarkers, and adverse events were evaluated. We explored the stimulation of phytoalexin (glyceollin) production in live viable soybean seeds (LSS-G). We compared the compositions of WGS and LSS-G with commercial soybean flour and its fermented and enzymatically hydrolyzed forms. We found that although 30 g WSG was well-tolerated, and it made participants feel full. Our processing produced glyceollins (267 µg/g) in LSS-G. Processing soybean flour decreased the iron content, but reduced the oligosaccharides, which could attenuate flatulence. Providing soybean flour at <30 g/day may be prudent for overall health and to prevent the exclusion of other food groups and nutrients in older adults with obesity.

Evaluation of noise regression techniques in resting-state fMRI studies using data of 434 older adults.

Subject motion is a well-known confound in resting-state functional MRI (rs-fMRI) and the analysis of functional connectivity. Consequently, several clean-up strategies have been established to minimize the impact of subject motion. Physiological signals in response to cardiac activity and respiration are also known to alter the apparent rs-fMRI connectivity. Comprehensive comparisons of common noise regression techniques showed that the "Independent Component Analysis based strategy for Automatic Removal of Motion Artifacts" (ICA-AROMA) was a preferred pre-processing technique for teenagers and adults. However, motion and physiological noise characteristics may differ substantially for older adults. Here, we present a comprehensive comparison of noise-regression techniques for older adults from a large multi-site clinical trial of exercise and intensive pharmacological vascular risk factor reduction. The Risk Reduction for Alzheimer's Disease (rrAD) trial included hypertensive older adults (60-84 years old) at elevated risk of developing Alzheimer's Disease (AD). We compared the performance of censoring, censoring combined with global signal regression, non-aggressive and aggressive ICA-AROMA, as well as the Spatially Organized Component Klassifikator (SOCK) on the rs-fMRI baseline scans from 434 rrAD subjects. All techniques were rated based on network reproducibility, network identifiability, edge activity, spatial smoothness, and loss of temporal degrees of freedom (tDOF). We found that non-aggressive ICA-AROMA did not perform as well as the other four techniques, which performed table with marginal differences, demonstrating the validity of these techniques. Considering reproducibility as the most important factor for longitudinal studies, given low false-positive rates and a better preserved, more cohesive temporal structure, currently aggressive ICA-AROMA is likely the most suitable noise regression technique for rs-fMRI studies of older adults.

Driving Performance in Older Adults: Current Measures, Findings, and Implications for Roadway Safety.

BACKGROUND AND OBJECTIVES: Over 10,000 people a day turn 65 in the United States. For many older adults, driving represents an essential component of independence and is one of the most important factors in overall mobility. Recent survey studies in older adults suggest that up to 60% of older adult drivers with mild cognitive impairment, and up to 30% with dementia, continue to drive. The purpose of this review is to provide a comprehensive and detailed resource on the topics of cognition and driving for clinicians, researchers, and policymakers working on efforts related to older adult drivers. RESEARCH DESIGN AND METHODS: Publications on PubMed and Medline and discussions with experts working in geriatrics, technology, driving policy, psychology, and diverse aspects of driving performance were utilized to inform the current review. RESULTS: Research indicates that there is a complex and inverse correlation between multiple cognitive measures, driving performance, and risky driving behaviors. The fragmented nature of available peer-reviewed literature, and a reliance on correlative data, do not currently allow for the identification of the temporal and reciprocal nature of the interplay between cognition and driving endpoints. DISCUSSION AND IMPLICATIONS: There are currently no widely accepted definitions, conceptual models, or uniform set of analyses for conducting geriatric research that is focused on driving. Establishing conventions for conducting research that harmonizes the fields of geriatrics, cognition, and driving research is critical for the development of the evidence base that will inform clinical practice and road safety policy.

Multimethod assessment of driving in older adults using a novel driving simulator.

Driving simulators may be an effective means of assessing driving performance, however many are cost-prohibitive. The present pilot study examined whether a novel, cost-effective driving simulator (Assetto Corsa (AC)) may be useful in the evaluation of older adults' driving performance, and explore associations among various driving safety indicators. A community sample of older adults completed a battery of cognitive measures, several self-reported driving measures, and a novel driving simulator task (AC). Simple attention, executive functioning, and processing speed were associated with simulator performance variables. Lower self-rated driving safety was associated with slower simulated driving. Additionally, several cognitive domains were associated with perceptions about driving-related safety and driving-related legal repercussions (e.g., traffic tickets). Findings suggested that associations between cognitive tests with AC were less robust than those found in other simulator studies. Novel associations between cognitive performance and self-reported driving were identified; however, given the small sample size of this study, such associations should be explored further.

Neuroimaging, Behavioral, and Gait Correlates of Fall Profile in Older Adults.

Prior research has suggested that measurements of brain functioning and performance on dual tasks (tasks which require simultaneous performance) are promising candidate predictors of fall risk among older adults. However, no prior study has investigated whether brain function measurements during dual task performance could improve prediction of fall risks and whether the type of subtasks used in the dual task paradigm affects the strength of the association between fall characteristics and dual task performance. In this study, 31 cognitively normal, community-dwelling older adults provided a self-reported fall profile (number of falls and fear of falling), completed a gait dual task (spell a word backward while walking on a GaitRite mat), and completed a supine dual task (rhythmic finger tapping with one hand while completing the AX continuous performance task (AX-CPT) with the other hand) during functional magnetic resonance imaging (fMRI). Gait performance, AX-CPT reaction time and accuracy, finger tapping cadence, and brain functioning in finger-tapping-related and AX-CPT-related brain regions all showed declines in the dual task condition compared to the single task condition. Dual-task gait, AX-CPT and finger tapping performance, and brain functioning were all independent predictors of fall profile. No particular measurement domain stood out as being the most strongly associated measure with fall variables. Fall characteristics are determined by multiple factors; brain functioning, motor task, and cognitive task performance in challenging dual-task conditions all contribute to the risk of falling.

Feasibility and validation of a web-based platform for the self-administered patient collection of demographics, health status, anxiety, depression, and cognition in community dwelling elderly.

The coronavirus disease pandemic has brought a new urgency for the development and deployment of web-based applications which complement, and offer alternatives to, traditional one-on-one consultations and pencil-and-paper (PaP) based assessments that currently dominate clinical research. We have recently developed a web-based application that can be used for the self-administered collection of patient demographics, self-rated health, depression and anxiety, and cognition as part of a single platform. In this study we report the findings from a study with 155 cognitively healthy older adults who received established PaP versions, as well as our novel computerized measures of self-rated health, depression and anxiety, and cognition. Moderate to high correlations were observed between PaP and web- based measures of self-rated health (r = 0.77), depression and anxiety (r = 0.72), and preclinical Alzheimer's disease cognitive composite (PACC) (r = .61). Test-retest correlations were variable with high correlations for a measure of processing speed and a measure of delayed episodic memory. Taken together, these data support the feasibility and validity of utilization of this novel web-based platform as a new alternative for collecting patient demographics and the assessment of self-rated health, depression and anxiety, and cognition in the elderly.

The Effects of Cardiovascular Risk Factors on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Performance in Cognitively Healthy Older Adults.

OBJECTIVE: The current study investigated the differential impact cardiovascular risk factors (CVRFs) on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) performance in a large, cognitively healthy, older adult sample across 4 years. METHOD: Participants were 486 individuals recruited through a longitudinal aging research study in the southeastern United States. Participants were 69.3% female, an average of 69.96 years old (SD = 6.58), 16.32 years of education (SD = 2.27), and Mini-Mental Status Exam score of 29.12 (SD = 1.16). Participants completed the RBANS at baseline and yearly thereafter, as well as the Uniform Data Set demographic and health questionnaires and the Geriatric Depression Scale. RESULTS: Multilevel modeling was conducted using standardized RBANS index scores. Overall, across indices, performance generally improved across time consistent with practice effects from repeated testing. Some CVRFs were associated with worse performance over time. For example, individuals with hypertension performed more poorly on immediate memory over time (t = -2.06, p < .05). Other CVRFs (e.g., BMI) were not associated with baseline performance or performance over time. (p > .05). CONCLUSIONS: CVRFs differentially affect RBANS performance over time. These results extend previous cross-sectional findings regarding the impact of different cardiovascular health risks to a large, cognitively healthy, longitudinal sample.

Baseline Prevalence of Polypharmacy in Older Hypertensive Study Subjects with Elevated Dementia Risk: Findings from the Risk Reduction for Alzheimer's Disease Study (rrAD).

BACKGROUND: Little is known about the prevalence of polypharmacy, the taking of five or more medications a day, in older adults with specific dementia risk factors. OBJECTIVE: To examine the prevalence of polypharmacy in participants at baseline in a vascular risk reduction focused Alzheimer's disease (rrAD) trial targeting older patients with hypertension and elevated dementia risk. METHODS: We conducted a detailed review of medications in a cross-sectional study of community-dwelling older adults with hypertension and elevated dementia risk. Medications were identified in a structured interview process with an onsite pharmacist or qualified designee. Polypharmacy was defined as use of five or more medications on a regular basis. Descriptive analyses were conducted on the sample as well as direct comparisons of subgroups of individuals with hypertension, diabetes, and hyperlipidemia. RESULTS: The 514 rrAD participants, mean age 68.8 (standard deviation [sd] 6), reported taking different combinations of 472 unique medications at their baseline visit. The median number of medications taken by participants was eight [Range 0-21], with 79.2% exhibiting polypharmacy (n = 407). Sites differed in their prevalence of polypharmacy, χ2(3) = 56.0, p < 0.001. A nearly identical percentage of the 2,077 prescribed (51.8%) and over the counter (48.2%) medications were present in the overall medication profile. The presence of diabetes (87.5%), hyperlipidemia (88.2%), or both (97.7%) was associated with a higher prevalence of polypharmacy than participants who exhibited hypertension in the absence of either of these conditions (63.2%), χ2(3) = 35.8, p < 0.001. CONCLUSION: Participants in a dementia risk study had high levels of polypharmacy, with the co-existence of diabetes or hyperlipidemia associated with a greater prevalence of polypharmacy as compared to having hypertension alone.

Comparison of Male and Female Patients in Louisiana Medical Marijuana Dispensaries.

Relatively little is known in terms of patient demographics, indications, previous cannabis use, or the forms and dosages of medical marijuana (MM) dispensed for patients at MM dispensaries. Even less is known in terms of how male and female patients may differ in each of these aspects. The goal of the current study was to examine each of these variables using a retrospective analysis of deidentified patient data from MM dispensaries in Louisiana. Deidentified data were analyzed from web-based pharmacist-patient consultations at MM dispensaries throughout Louisiana. Data were collected during the first 6 months following the initiation of the MM dispensing program in Louisiana. A total of 1195 MM patients (598 male/597 female) were included in the analyses. The average age of the sample was 51.9 years (±14.8) and it was composed primarily of white patients (86.7%). Males and females were nearly identical in terms of average age, race, previous cannabis use, indication profile, and MM recommendations. Differences between males and females were observed in terms of opioid use, history of psychosis, presence of more than one indication, and the duration of previous cannabis use. Our data indicate that, in MM dispensaries of the Deep South state, there are numerous similarities-and some potentially important differences-between male and female MM patients. The importance of these differences, and the importance of continued data collection/analysis, for improving MM dispensing are discussed.

Do menopausal status and APOE4 genotype alter the long-term effects of intensive lifestyle intervention on cognitive function in women with type 2 diabetes mellitus?

In the Look AHEAD trial, randomization to Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE) did not result in differences in cognitive outcomes. However, menopause and APOE genotype are factors that affect the response to this intervention. The effect of this intervention on a single cognitive assessment was examined in 3 groups of women: premenopausal or <5 years postmenopausal (N = 594), within 5-10 years (n = 388), and ≥10 years postmenopausal (n = 963), and as a function of continuous years since menopause. The late postmenopausal group in the ILI had worse composite z-scores compared to those in the DSE, whereas the younger premenopausal or early postmenopausal women in the ILI had better composite z-scores than the DSE. A significant interaction between years since menopause and intervention arm, but not baseline age, was observed on executive function domains. ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause. These findings emphasize the importance of assessing menopause and APOE status to understand how weight loss impacts cognition.

Predictors of Heterogeneity in Cognitive Function: APOE-e4, Sex, Education, Depression, and Vascular Risk.

OBJECTIVE: Mild cognitive impairment and dementia are clinically heterogeneous disorders influenced by diverse risk factors. Improved characterization of the effect of multiple risk factors influence on specific cognitive functions may improve understanding of mechanisms in early cognitive change and lead to more effective interventions. METHODS: Structural equation modeling (SEM) simultaneously examined the effects of modifiable (education, depression, and metabolic/vascular risk) and nonmodifiable risk factors (age, sex, and apolipoprotein E-ɛ4 allele [APOE-e4] status) on specific cognitive domains in 461 cognitively normal older adults. RESULTS: The hypothesized model(s) provided an adequate fit for the data. Sex differences in cognition, depression, and vascular risk were found. On average, men were higher in vascular risk with generally lower cognitive performance than women; women were more likely to have depression. APOE-e4 associated with depression but not age, sex, or metabolic/vascular risk. Depression associated with lower executive attention, memory, and language performance, whereas metabolic/vascular risk associated with lower executive attention, memory, and working memory. Older age and lower education are associated with worse performance across the cognitive domains. The combined risk factors accounted for 16%-47% of the variance in the cognitive domains. CONCLUSIONS: Results highlight the combined effect of risk factors on cognitive function. Future research is needed to determine whether the multifactorial risk effects on cognition vary by sex. Precision medicine approaches that integrate neuropsychological services may improve diagnostic accuracy and earlier identification of those at risk of cognitive decline.

Examining Relationships between Multiple Self-Reported Sleep Measures and Gait Domains in Cognitively Healthy Older Adults.

BACKGROUND: Gait-related changes in older adulthood may be related to changes in cognition (e.g., executive functioning), and recent work suggests that different self-reported measures of sleep may be tied to contrasting aspects of executive functioning. However, the relationship between these self-reported sleep measures and gait domains has not been explored. Such an investigation would be useful in helping to determine which older adults might exhibit changes in gait as well as experience other gait-associated changes (e.g., increased fall risk). OBJECTIVE: To examine associations between different aspects of self-reported sleep and gait domains in a sample of cognitively healthy older adults. METHOD: A total of 423 older adults (mean age 69.9 years, range 50-92) completed self-report measures of sleep quality, daytime sleepiness, and sleep-related distress. The participants also completed an objective, electronic measure of both single-task and dual-task gait (i.e., GAITRite). Principal component analyses were used to elucidate the solution for each gait condition, and multiple linear regression was used to examine the contributions of sleep measures to variability in gait performance. RESULTS: A 5-component solution of the single-task condition and a 4-component solution of the dual-task condition were identified. Multiple linear regressions revealed that a poorer sleep quality was associated with greater single-task and dual-task asymmetry. Greater daytime sleepiness was associated with increased dual-task gait variability and postural control. After controlling for the effects of other facets of sleep, sleep-related distress was not associated with any gait domain. CONCLUSIONS: Among cognitively healthy older adults,sleep quality and daytime sleepiness, but not sleep-related distress, are associated with aspects of gait. Patients who report these symptoms should be assessed and monitored for possible changes in gait.

The db mutation improves memory in younger mice in a model of Alzheimer's disease.

Alzheimer's disease (AD) is the most common age-related neurodegenerative disease, while obesity is a major global public health problem associated with the metabolic disorder type 2 diabetes mellitus (T2DM). Chronic obesity and T2DM have been identified as invariant risk factors for dementia and late-onset AD, while their impacts on the occurrence and development of AD remain unclear. As shown in our previous study, the diabetic mutation (db, Leprdb/db) induces mixed or vascular dementia in mature to middle-aged APPΔNL/ΔNL x PS1P264L/P264L knock-in mice (db/AD). In the present study, the impacts of the db mutation on young AD mice at 10 weeks of age were evaluated. The db mutation not only conferred young AD mice with severe obesity, impaired glucose regulation and activated mammalian target of rapamycin (mTOR) signaling pathway in the mouse cortex, but lead to a surprising improvement in memory. At this young age, mice also had decreased cerebral Aß content, which we have not observed at older ages. This was unlikely to be related to altered Aß synthesis, as both ß- and γ-secretase were unchanged. The db mutation also reduced the cortical IL-1ß mRNA level and IBA1 protein level in young AD mice, with no significant effect on the activation of microglia and astrocytes. We conclude that the db mutation could transitorily improve the memory of young AD mice, a finding that may be partially explained by the relatively improved glucose homeostasis in the brains of db/AD mice compared to their counterpart AD mice, suggesting that glucose regulation could be a strategy for prevention and treatment of neurodegenerative diseases like AD.

Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study).

Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664.

Pedometer-assessed steps per day as a predictor of cognitive performance in older adults.

OBJECTIVE: To examine associations between pedometer-assessed daily steps and several domains of cognitive functioning in cognitive healthy older adults. METHOD: A total of 582 cognitively healthy older adults enrolled in a longitudinal aging study completed the Uniform Data Set (UDS) neuropsychological battery (n = 374) or the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; n = 208) and were asked to wear a pedometer for 1 week. RESULTS: Bivariate correlations revealed associations between average daily steps and attention, executive functioning, language, and memory on one or both cognitive batteries. Multiple regression analyses controlling for demographic, health, and mobility variables demonstrated a significant relationship between average daily steps and the executive functioning composite of the UDS battery and average daily steps and the attention index of the RBANS battery. Both of these composites include measures of processing speed and, therefore, the most robust link between daily steps and cognition may be its association with processing speed. CONCLUSIONS: Step counts as measured by a pedometer, a simple and inexpensive measure of daily physical activity, are robustly associated with aspects of cognition. As pedometer-based interventions have shown success in increasing daily physical activity in older adults, a greater number of future studies should consider measuring cognitive outcomes of these interventions. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Multiple self-reported sleep measures are differentially associated with cognitive performance in community-dwelling nondemented elderly.

OBJECTIVE: To examine associations between daytime and insomnia-related sleep problems with different domains of cognitive functioning and determine whether subclinical depressive symptoms and age moderate these associations. METHOD: A total of 903 cognitively healthy older adults enrolled in a longitudinal aging study completed the UDS neuropsychological battery (measuring attention, executive functioning, episodic memory, language and processing speed). Subclinical depressive symptoms were also assessed and self-reported measures of sleep were administered. RESULTS: Hierarchical multiple regression analyses separately assessing the effects of daytime and insomnia-related sleep problems on cognition identified relationships between both daytime and insomnia-related sleep problems with a composite measure of executive functioning; however, the former was related more to speed of processing and the latter to higher order executive abilities. Age moderated the relationship between insomnia severity and executive functioning, and subclinical depressive symptoms moderated the relationship between insomnia-related sleep problems and performance on measures of attention. CONCLUSIONS: Among older adults, sleep problems have a deleterious effect on executive functioning regardless of whether they occur during the day or nighttime; however, age and subclinical depressive symptoms differentially impact relationships between sleep variables and cognitive domains. (PsycINFO Database Record

Understanding heterogeneity in older adults: Latent growth curve modeling of cognitive functioning.

BACKGROUND: Clarifying relationships between specific neurocognitive functions in cognitively intact older adults can improve our understanding of mechanisms involved in cognitive decline, which may allow identification of new opportunities for intervention and earlier detection of those at increased risk of dementia. METHOD: The present study employed latent growth curve modeling to longitudinally examine the relationship between executive attention/processing speed, episodic memory, language, and working memory functioning utilizing the neuropsychological test battery from the National Alzheimer's Disease Coordinating Center. A total of 691 relatively healthy older adults (Mage = 69.07, SD = 6.49) were assessed at baseline, and 553 individuals completed three visits spanning a two-year period. RESULTS: Better cognitive performance was concomitantly associated with better functioning across domains. Subtle declines in executive attention/processing speed processes were found, while, on average, memory and language performance improved with repeated testing. Lower executive attention/processing speed performance at baseline predicted less incremental growth rate in memory. In turn, higher initial memory functioning was associated with incremental improvements in language performance. CONCLUSIONS: These results are consistent with the notion that intact executive function and attention processes are important to preserving memory functioning with advanced age, but are also the functions most susceptible to decline with age. These findings also provide further insight into the critical role of practice effects in clinical assessment practice and have implications for pharmaceutical trials. Practice effects should be routinely considered as they may give the appearance of retention of function within the cognitive domains considered to be a hallmark of Alzheimer's disease pathology.

Effect of a Long-Term Intensive Lifestyle Intervention on Cognitive Function: Action for Health in Diabetes Study.

OBJECTIVES: To assess whether randomization to 10 years of lifestyle intervention to induce and maintain weight loss improves cognitive function. DESIGN: Randomized controlled clinical trial. SETTING: Data obtained as part of the Action for Health in Diabetes (Look AHEAD) trial (NCT00017953) and Look AHEAD Continuation study (U01 DK057136-15). PARTICIPANTS: Overweight and obese individuals with type 2 diabetes mellitus aged 45 to 76 (N = 3,751). INTERVENTION: Intensive lifestyle intervention (ILI) for weight loss through reduced caloric intake and increased physical activity compared with a control condition of diabetes support and education (DSE). MEASUREMENTS: Certified examiners who were masked to intervention assignment administered a standard battery of cognitive function tests (Modified Mini-Mental State Examination, Rey Auditory Verbal Learning Test, Digit Symbol Coding, Trail-Making Test, Modified Stroop Color-Word Test) to participants 10 to 13 years after enrollment. RESULTS: Assignment to lifestyle intervention was not associated with significantly different overall (P = .10) or domain-specific (all P > .10) cognitive function than assignment to diabetes support and education. Results were fairly consistent across prespecified groups, but there was some evidence of trends for differential intervention effects showing modest harm in ILI in participants with greater body mass index and in individuals with a history of cardiovascular disease. Cognitive function was not associated with changes in weight or fitness (all P > .05). CONCLUSION: A long-term behavioral weight loss intervention for overweight and obese adults with diabetes mellitus was not associated with cognitive benefit. Trial Registration clinicaltrials.gov Identifier: NCT00017953.

Reliability and Validity of a Novel Internet-Based Battery to Assess Mood and Cognitive Function in the Elderly.

Dementia is a chronic condition in the elderly and depression is often a concurrent symptom. As populations continue to age, accessible and useful tools to screen for cognitive function and its associated symptoms in elderly populations are needed. The aim of this study was to test the reliability and validity of a new internet-based assessment battery for screening mood and cognitive function in an elderly population. Specifically, the Helping Hand Technology (HHT) assessments for depression (HHT-D) and global cognitive function (HHT-G) were evaluated in a sample of 57 elderly participants (22 male, 35 female) aged 59-85 years. The study sample was categorized into three groups: 1) dementia (n = 8; Mini-Mental State Exam (MMSE) score 10-24), 2) mild cognitive impairment (n = 24; MMSE score 25-28), and 3) control (n = 25; MMSE score 29-30). Test-retest reliability (Pearson correlation coefficient, r) and internal consistency reliability (Cronbach's alpha, α) of the HHT-D and HHT-G were assessed. Validity of the HHT-D and HHT-G was tested via comparison (Pearson r) to commonly used pencil-and-paper based assessments: HHT-D versus the Geriatric Depression Scale (GDS) and HHT-G versus the MMSE. Good test-retest (r = 0.80; p < 0.0001) and acceptable internal consistency reliability (α= 0.73) of the HHT-D were established. Moderate support for the validity of the HHT-D was obtained (r = 0.60 between the HHT-D and GDS; p < 0.0001). Results indicated good test-retest (r = 0.87; p < 0.0001) and acceptable internal consistency reliability (α= 0.70) of the HHT-G. Validity of the HHT-G was supported (r = 0.71 between the HHT-G and MMSE; p < 0.0001). In summary, the HHT-D and HHT-G were found to be reliable and valid computerized assessments to screen for depression and cognitive status, respectively, in an elderly sample.