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04/2019 journal articles

Editorials

A TURNING POINT IN ALZHEIMER’S RESEARCH: HARMONIZED RESEARCH STRATEGIES AND NOVEL INVESTMENTS IN PUBLIC HEALTH INFRASTRUCTURE ARE REENERGIZING THE FIELD, AND REKINDLING HOPE FOR THOSE AFFECTED BY ALZHEIMER’S AND RELATED DEMENTIAS

M.C. Carrillo, H.M. Snyder, R. Conant, S. Worley, R. Egge

J Prev Alz Dis 2019;6(4):214-216

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CITATION:
M.C. Carrillo ; H.M. Snyder ; R. Conant ; S. Worley ; R. Egge (2019): A Turning Point in Alzheimer’s Research: Harmonized Research Strategies and Novel Investments in Public Health Infrastructure Are Reenergizing the Field, and Rekindling Hope for Those Affected by Alzheimer’s and Related Dementias. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.36

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CAN DIGITAL TECHNOLOGY ADVANCE THE DEVELOPMENT OF TREATMENTS FOR ALZHEIMER’S DISEASE?

M. Mc Carthy, P. Schueler

J Prev Alz Dis 2019;6(4):217-220

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The report explores the potential digital technology has to generate novel endpoints and digital biomarkers for Alzheimer’s disease drug development studies. Drawing from literature and novel pilots, we explore the value of innovative digital technology to digitize physiological behaviours such as sleep disturbance and gait changes. Technology now exists to monitor and quantify our use and interaction with electronics in the home, the use of social platforms and smart-phones, geolocation, sleep and activity patterns. These multimodal digital data are a feasible alternative to capturing the more complex activities of daily living that require higher cognitive processes and are a sensitive predictor of disease. The combination of biosensors and the internet of things (IoT), offers the potential to collect highly relevant, objective data in a continuous, passive and low burden manner. Digital endpoints and biomarkers could have value in the diagnosis, monitoring and development of therapies for patients living with Alzheimer’s disease.

CITATION:
M. Mc Carthy ; P. Schueler (2019): Can Digital Technology Advance the Development of Treatments for Alzheimer’s Disease?. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.32

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IS A LARGE-SCALE SCREENING FOR ALZHEIMER’S DISEASE POSSIBLE? YES, IN A FEW YEARS

F. Ribaldi, D. Altomare, G.B. Frisoni

J Prev Alz Dis 2019;6(4):221-222

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CITATION:
F. Ribaldi ; D. Altomare ; G.B. Frisoni (2019): Is a Large-Scale Screening for Alzheimer’s Disease Possible? Yes, in a Few Years. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.29

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Brief Report

THE 2018 REVISED FDA GUIDANCE FOR EARLY ALZHEIMER’S DISEASE: ESTABLISHING THE MEANINGFULNESS OF TREATMENT EFFECTS

C.J. Edgar, G. Vradenburg, J. Hassenstab

J Prev Alz Dis 2019;6(4):223-227

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The present report reviews the revised 2018 FDA guidance for early AD, with an emphasis on meaningfulness of clinical outcome assessments (COAs). A radical shift is evident in the importance given to establishing the meaningfulness of COAs in the 2018 draft versus the 2013 draft. The implications of this shift include the assertion that cognition is clinically meaningful, but that a persuasive effect on cognition, depending upon disease stage of the participants in the trial, is one that is of enough magnitude, established across multiple relevant domains, and can be supported by biomarkers reflecting underlying AD pathological changes. Meaningfulness is established through an understanding of the conceptual relevance of what is being measured and magnitude of any treatment effect. Precedent exists within other FDA guidance and independent good practices publications as to how meaningfulness may be assessed e.g. via evaluation of content validity and concepts such as minimally important difference. Additionally, FDA is developing a series of methodological Patient Focused Drug Development (PFDD) documents to provide further guidance on this topic, which are aimed at addressing gaps in methodology and recommended best practice. Importantly, application of PFDD approaches to AD is behind that in other areas and there is limited published content validity for COAs and a lack of supportive qualitative research. Initiatives to build robust conceptual models of AD and develop novel direct measures of meaningful health outcomes will have a significant impact on measurement of efficacy in clinical trials and on payer determinations of beneficiary value. Greater recognition of what is meaningful from the perspective of the patient and caregiver will inform regulatory reviews and determinations for payment and coverage of treatments.

CITATION:
C.J. Edgar ; G. Vradenburg ; J. Hassenstab (2019): The 2018 Revised FDA Guidance for Early Alzheimer’s Disease: Establishing the Meaningfulness of Treatment Effects. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.30

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RANDOMIZED, PLACEBO CONTROLLED TRIAL OF NPT088, A PHAGE-DERIVED, AMYLOID-TARGETED TREATMENT FOR ALZHEIMER’S DISEASE

D. Michelson, M. Grundman, K. Magnuson, R. Fisher, J.M. Levenson, P. Aisen, K. Marek, M. Gray, F. Hefti

J Prev Alz Dis 2019;6(4):228-231

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The engineered fusion protein NPT088 targets amyloid in vitro and in animal models of Alzheimer’s disease. Previous studies showed that NPT088 treatment reduced β-amyloid plaque and tau aggregate loads in mouse disease models. Here, we present the results from an initial clinical study of NPT088 in patients with mild to moderate Alzheimer’s disease. Patients were treated with 4 dose levels of NPT088 for 6 months to evaluate its safety and tolerability. Exploratory measurements included measurement of change in β-amyloid plaque and tau burden utilizing Positron Emission Tomography imaging as well as measures of Alzheimer’s disease symptoms. At endpoint NPT088 was generally safe and well-tolerated with the most prominent finding being infusion reactions in a minority of patients. No effect of NPT088 on brain plaques, tau aggregates or Alzheimer’s disease symptoms was observed.

CITATION:
D. Michelson ; M. Grundman ; K. Magnuson ; R. Fisher ; J.M. Levenson ; P. Aisen ; K. Marek ; M. Gray ; F. Hefti (2019): Randomized, Placebo Controlled Trial of NPT088, A Phage-Derived, Amyloid-Targeted Treatment for Alzheimer’s Disease. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.37

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ALZHEIMER’S DISEASE COMPOSITE SCORE: A POST-HOC ANALYSIS USING DATA FROM THE LIPIDIDIET TRIAL IN PRODROMAL ALZHEIMER’S DISEASE

S.B. Hendrix, H. Soininen, A.M.J. van Hees, N. Ellison, P.J. Visser, A. Solomon, A. Attali, K. Blennow, M. Kivipelto, T. Hartmann

J Prev Alz Dis 2019;6(4):232-236

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As research evolves in prodromal AD, the need to validate sufficiently sensitive outcome measures, e.g. the Alzheimer’s Disease Composite Score (ADCOMS) is clear. In the LipiDiDiet randomized trial in prodromal AD, cognitive decline in the study population was much less than expected in the timeframe studied. While the primary composite endpoint was insufficiently sensitive to detect a difference in the modified intention to treat population, the per-protocol population showed less decline in the active than the control group, indicating better treatment effects with regular product intake. These results were further strengthened by significant benefits on secondary endpoints of cognition and function, and brain atrophy. The present post-hoc analysis investigated whether ADCOMS could detect a difference between groups in the LipiDiDiet population (138 active, 140 control). The estimated mean change in ADCOMS from baseline (standard error) was 0.085 (0.018) in the active and 0.133 (0.018) in the control group; estimated mean treatment difference -0.048 (95% confidence intervals -0.090, -0.007; p=0.023), or 36% less decline in the active group. This suggests ADCOMS identified the cognitive and functional benefits observed previously, confirming the sensitivity of this composite measure.

CITATION:
S.B. Hendrix ; H. Soininen ; A.M.J. van Hees ; N. Ellison ; P.J. Visser ; A. Solomon ; A. Attali ; K. Blennow ; M. Kivipelto ; T. Hartmann (2019): Alzheimer’s Disease Composite Score: a Post-Hoc Analysis Using Data from the LipiDiDiet Trial in Prodromal Alzheimer’s Disease. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.33

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COMPARING THE STANDARD AND ELECTRONIC VERSIONS OF THE ALZHEIMER’S DISEASE ASSESSMENT SCALE – COGNITIVE SUBSCALE: A VALIDATION STUDY

T.M. Solomon, J.M. Barbone, H.T. Feaster, D.S. Miller, G.B. deBros, C.A. Murphy, D. Michalczuk

J Prev Alz Dis 2019;6(4):237-241

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The Alzheimer’s Disease Assessment Scale (ADAS-Cog) has become the de facto gold-standard for assessing the efficacy of putative anti-dementia treatments. There has been an increasing interest in providing greater standardization, automation, and administration consistency to the scale. Recently, electronic versions of the ADAS-Cog (eADAS-Cog) have been utilized in clinical trials and demonstrated significant reductions in frequency of rater error as compared to paper. In order to establish validity of the electronic version (eADAS-Cog), 20 subjects who had received a diagnosis of probable Alzheimer’s disease (AD) at a private US Memory Clinic completed a single-center, randomized, counterbalanced, prospective trial comparing a version of the eADAS-Cog to the standard paper scale. Interclass Correlation Coefficient on total scores and Kappa analysis on domain scores yielded high agreement (0.88 - 0.99). Effects of order and mode of administration on ADAS-Cog total scores did not demonstrate a significant main effect. Overall, this study establishes adequate concurrent validity between the ADAS-Cog and eADAS-Cog among an adult population with diagnosed AD.

CITATION:
T.M. Solomon ; J.M. Barbone ; H.T. Feaster ; D.S. Miller ; G.B. deBros ; C.A. Murphy ; D. Michalczuk (2019): Comparing the Standard and Electronic Versions of the Alzheimer’s Disease Assessment Scale – Cognitive Subscale: A Validation Study. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.27

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Short Communication

NEUROPSYCHOLOGICAL, PSYCHIATRIC, AND FUNCTIONAL CORRELATES OF CLINICAL TRIAL ENROLLMENT

D.B. Hammers, N.L. Foster, J.M. Hoffman, T.H. Greene, K. Duff

J Prev Alz Dis 2019;6(4):242-247

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Screen failure rates in Alzheimer’s disease (AD) clinical trial research are unsustainable, with participant recruitment being a top barrier to AD research progress. The purpose of this project was to understand the neuropsychological, psychiatric, and functional features of individuals who failed screening measures for AD trials. Previously collected clinical data from 38 patients (aged 50-83) screened for a specific industry-sponsored clinical trial of MCI/early AD (Biogen 221AD302, [EMERGE]) were analyzed to identify predictors of AD trial screen pass/fail status. Worse performance on non-memory cognitive domains like crystalized knowledge, executive functioning, and attention, and higher self-reported anxiety, was associated with failing the screening visit for the EMERGE AD clinical trial, whereas we were not able to detect a relationship between screening status and memory performance, self-reported depression, or self-reported daily functioning. By identifying predictors of AD trial screen passing/failure, this research may influence decision-making about which patients are most likely to successfully enroll in a trial, thereby potentially lowering participant burden, maximizing study resources, and reducing costs.

CITATION:
D.B. Hammers ; N.L. Foster ; J.M. Hoffman ; T.H. Greene ; K. Duff (2019): Neuropsychological, Psychiatric, and Functional Correlates of Clinical Trial Enrollment. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.38

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Original Research

APPLICATION OF THE NIA-AA RESEARCH FRAMEWORK: TOWARDS A BIOLOGICAL DEFINITION OF ALZHEIMER’S DISEASE USING CEREBROSPINAL FLUID BIOMARKERS IN THE AIBL STUDY

S.C. Burnham, P.M. Coloma, Q.-X. Li, S. Collins, G. Savage, S. Laws, J. Doecke, P. Maruff, R.N. Martins, D. Ames, C.C. Rowe, C.L. Masters, V.L. Villemagne

J Prev Alz Dis 2019;6(4):248-255

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BACKGROUND: The National Institute on Aging and Alzheimer’s Association (NIA-AA) have proposed a new Research Framework: Towards a biological definition of Alzheimer’s disease, which uses a three-biomarker construct: Aß-amyloid, tau and neurodegeneration AT(N), to generate a biomarker based definition of Alzheimer’s disease. OBJECTIVES: To stratify AIBL participants using the new NIA-AA Research Framework using cerebrospinal fluid (CSF) biomarkers. To evaluate the clinical and cognitive profiles of the different groups resultant from the AT(N) stratification. To compare the findings to those that result from stratification using two-biomarker construct criteria (AT and/or A(N)). DESIGN: Individuals were classified as being positive or negative for each of the A, T, and (N) categories and then assigned to the appropriate AT(N) combinatorial group: A-T-(N)-; A+T-(N)-; A+T+(N)-; A+T-(N)+; A+T+(N)+; A-T+(N)-; A-T-(N)+; A-T+(N)+. In line with the NIA-AA research framework, these eight AT(N) groups were then collapsed into four main groups of interest (normal AD biomarkers, AD pathologic change, AD and non-AD pathologic change) and the respective clinical and cognitive trajectories over 4.5 years for each group were assessed. In two sensitivity analyses the methods were replicated after assigning individuals to four groups based on being positive or negative for AT biomarkers as well as A(N) biomarkers. SETTING: Two study centers in Melbourne (Victoria) and Perth (Western Australia), Australia recruited MCI individuals and individuals with AD from primary care physicians or tertiary memory disorder clinics. Cognitively healthy, elderly NCs were recruited through advertisement or via spouses of participants in the study. PARTICIPANTS: One-hundred and forty NC, 33 MCI participants, and 27 participants with AD from the AIBL study who had undergone CSF evaluation using Elecsys® assays. INTERVENTION (if any): Not applicable. MEASUREMENTS: Three CSF biomarkers, namely amyloid β1-42, phosphorylated tau181, and total tau, were measured to provide the AT(N) classifications. Clinical and cognitive trajectories were evaluated using the AIBL Preclinical Alzheimer Cognitive Composite (AIBL-PACC), a verbal episodic memory composite, an executive function composite, California Verbal Learning Test – Second Edition; Long-Delay Free Recall, Mini-Mental State Examination, and Clinical Dementia Rating Sum of Boxes scores. RESULTS: Thirty-eight percent of the elderly NCs had no evidence of abnormal AD biomarkers, whereas 33% had biomarker levels consistent with AD or AD pathologic change, and 29% had evidence of non-AD biomarker change. Among NC participants, those with biomarker evidence of AD pathology tended to perform worse on cognitive outcome assessments than other biomarker groups. Approximately three in four participants with MCI or AD had biomarker levels consistent with the research framework’s definition of AD or AD pathologic change. For MCI participants, a decrease in AIBL-PACC scores was observed with increasing abnormal biomarkers; and increased abnormal biomarkers were also associated with increased rates of decline across some cognitive measures. CONCLUSIONS: Increasing biomarker abnormality appears to be associated with worse cognitive trajectories. The implementation of biomarker classifications could help better characterize prognosis in clinical practice and identify those at-risk individuals more likely to clinically progress, for their inclusion in future therapeutic trials.

CITATION:
S.C. Burnham ; P.M. Coloma ; Q.-X. Li ; S. Collins ; G. Savage ; S. Laws ; J. Doecke ; P. Maruff ; R.N. Martins ; D. Ames ; C.C. Rowe ; C.L. Masters ; V.L. Villemagne (2019): Application of the NIA-AA Research Framework: Towards a Biological Definition of Alzheimer’s Disease using Cerebrospinal Fluid Biomarkers in the AIBL Study. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.25

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PROSPECTIVE EVALUATION OF COGNITIVE HEALTH AND RELATED FACTORS IN ELDERLY AT RISK FOR DEVELOPING ALZHEIMER’S DEMENTIA: A LONGITUDINAL COHORT STUDY

C. Udeh-Momoh, G. Price, M.T. Ropacki, N. Ketter, T. Andrews, H.M. Arrighi, H.R. Brashear, C. Robb, D.T. Bassil, M. Cohn, L.K. Curry, B. Su, D. Perera, P. Giannakopoulou, J. Car, H.A. Ward, R. Perneczky, G. Novak, L. Middleton

J Prev Alz Dis 2019;6(4):256-266

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Background: The CHARIOT PRO Main study is a prospective, non-interventional study evaluating cognitive trajectories in participants at the preclinical stage of Alzheimer’s disease (AD) classified by risk levels for developing mild cognitive impairment due to AD (MCI-AD). Objectives: The study aimed to characterize factors and markers influencing cognitive and functional progression among individuals at-risk for developing MCI-AD, and examine data for more precise predictors of cognitive change, particularly in relation to APOE ε4 subgroup. Design: This single-site study was conducted at the Imperial College London (ICL) in the United Kingdom. Participants 60 to 85 years of age were classified as high, medium (amnestic or non-amnestic) or low risk for developing MCI-AD based on RBANS z-scores. A series of clinical outcome assessments (COAs) on factors influencing baseline cognitive changes were collected in each of the instrument categories of cognition, lifestyle exposure, mood, and sleep. Data collection was planned to occur every 6 months for 48 months, however the median follow-up time was 18.1 months due to early termination of study by the sponsor. Results: 987 participants were screened, among them 690 participants were actively followed-up post baseline, of whom 165 (23.9%) were APOE ε4 carriers; with at least one copy of the allele. The mean age was 68.73 years, 94.6% were white, 57.4% were female, and 34.8% had a Family History of Dementia with a somewhat larger percentage in the APOE ε4 carrier group (42.4%) compared to the non-carrier group (32.4%). Over half of the participants were married and 53% had a Bachelor’s or higher degree. Most frequently, safety events typical for this population consisted of upper respiratory tract infection (10.4%), falls (5.2%), hypertension (3.5%) and back pain (3.0%). Conclusion (clinical relevance): AD-related measures collected during the CHARIOT PRO Main study will allow identification and evaluation of AD risk factors and markers associated with cognitive performance from the pre-clinical stage. Evaluating the psycho-biological characteristics of these pre-symptomatic individuals in relation to their natural neurocognitive trajectories will enhance current understanding on determinants of the initial signs of cognitive changes linked to AD.

CITATION:
C. Udeh-Momoh ; G. Price ; M.T. Ropacki ; N. Ketter ; T. Andrews ; H.M. Arrighi ; H.R. Brashear ; C. Robb ; D.T. Bassil ; M. Cohn ; L.K. Curry ; B. Su ; D. Perera ; P. Giannakopoulou ; J. Car ; H.A. Ward ; R. Perneczky ; G. Novak ; L. Middleton (2019): Prospective Evaluation of Cognitive Health and Related Factors in Elderly at Risk for Developing Alzheimer’s Dementia: A Longitudinal Cohort Study. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.31

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MEDITERRANEAN-DASH INTERVENTION FOR NEURODEGENERATIVE DELAY (MIND) DIET SLOWS COGNITIVE DECLINE AFTER STROKE

L. Cherian, Y. Wang, K. Fakuda, S. Leurgans, N. Aggarwal, M. Morris

J Prev Alz Dis 2019;6(4):267-273

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Objective: This study sought to determine if the MIND diet (a hybrid of the Mediterranean and Dash diets, with modifications based on the science of nutrition and the brain), is effective in preventing cognitive decline after stroke. Design: We analyzed 106 participants of a community cohort study who had completed a diet assessment and two or more annual cognitive assessments and who also had a clinical history of stroke. Cognition in five cognitive domains was assessed using structured clinical evaluations that included a battery of 19 cognitive tests. MIND diet scores were computed using a valid food frequency questionnaire (FFQ). Dietary components of the MIND diet included whole grains, leafy greens and other vegetables, berries, beans, nuts, lean meats, fish, poultry, and olive oil and reduced consumption of cheese, butter, fried foods, and sweets. MIND diet scores were modeled in tertiles. The influence of baseline MIND score on change in a global cognitive function measure and in the five cognitive domains was assessed using linear mixed models adjusted for age and other potential confounders. Results: With adjustment for age, sex, education, APOE-ε4, caloric intake, smoking, and participation in cognitive and physical activities, the top vs lowest tertiles of MIND diet scores had a slower rate of global cognitive decline (β = .08; CI = 0.0074, 0.156) over an average of 5.9 years of follow-up. Conclusions: High adherence to the MIND diet was associated with a slower rate of cognitive decline after stroke.

CITATION:
L. Cherian ; Y. Wang ; K. Fakuda ; S. Leurgans ; N. Aggarwal ; M. Morris (2019): Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) Diet Slows Cognitive Decline After Stroke . The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.28

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FINANCIAL MANAGEMENT SKILLS IN AGING, MCI AND DEMENTIA: CROSS SECTIONAL RELATIONSHIP TO 18F-FLORBETAPIR PET CORTICAL Β-AMYLOID DEPOSITION

S. Tolbert, Y. Liu, C. Hellegers, J.R. Petrella, M.W. Weiner, T.Z. Wong, P. Murali Doraiswamy, for the ADNI Study Group

J Prev Alz Dis 2019;6(4):274-282

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Background: There is a need to more fully characterize financial capacity losses in the preclinical and prodromal stages of Alzheimer’s disease (AD) and their pathological substrates. Objectives: To test the association between financial skills and cortical β-amyloid deposition in aging and subjects at risk for AD. Design: Cross-sectional analyses of data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI-3) study conducted across 50 plus sites in the US and Canada. Setting: Multicenter biomarker study. Participants: 243 subjects (144 cognitively normal, 79 mild cognitive impairment [MCI], 20 mild AD). Measurements: 18F-Florbetapir brain PET scans to measure global cortical β-amyloid deposition (SUVr) and the Financial Capacity Instrument Short Form (FCI-SF) to evaluate an individual’s financial skills in monetary calculation, financial concepts, checkbook/register usage, and bank statement usage. There are five sub scores and a total score (range of 0–74) with higher scores indicating better financial skill. Results: FCI-SF total score was significantly worse in MCI [Cohen’s d= 0.9 (95%CI: 0.6-1.2)] and AD subjects [Cohen’s d=3.1(CI: 2.5-3.7)] compared to normals. Domain scores and completion times also showed significant difference. Across all subjects, higher cortical β-amyloid SUVr was significantly associated with worse FCI-SF total score after co-varying for age, education, and cognitive score [Cohen’s f2=0.751(CI: 0.5-1.1)]. In cognitively normal subjects, after covarying for age, gender, and education, higher β -amyloid PET SUVr was associated with longer task completion time [Cohen’s f2=0.198(CI: 0.06-0.37)]. Conclusion: Using a multicenter study sample, we document that financial capacity is impaired in the prodromal and mild stages of AD and that such impairments are, in part, associated with the extent of cortical β-amyloid deposition. In normal aging, β-amyloid deposition is associated with slowing of financial tasks. These data confirm and extend prior research highlighting the utility of financial capacity assessments in at risk samples.

CITATION:
S. Tolbert ; Y. Liu ; C. Hellegers ; J.R. Petrella ; M.W. Weiner ; T.Z. Wong ; P. Murali Doraiswamy ; for the ADNI Study Group (2019): Financial Management Skills in Aging, MCI and Dementia: Cross Sectional Relationship to 18F-Florbetapir PET Cortical β-amyloid Deposition. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2019.26

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