Alzheimer''s and Dementia: Translational Research and Clinical Interventions最新文献

{"title":"The promotion of physical activity for use in Alzheimer's disease prevention trials in adults with Down syndrome: Results from a 12-month randomized trial","authors":"Lauren T. Ptomey, Brian C. Helsel, Richard A. Washburn, Robert N. Montgomery, Ron Krebill, Jessica C. Danon, Joseph R. Sherman, Daniel Forsha, Amy Bodde, Amanda N. Szabo-Reed, Anna M. Gorczyca, Joseph E. Donnelly","doi":"10.1002/trc2.70115","DOIUrl":"https://doi.org/10.1002/trc2.70115","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> INTRODUCTION</h3>\u0000 \u0000 <p>Alzheimer's disease (AD) is the leading cause of death in individuals with Down syndrome (DS). Participation in moderate-to-vigorous physical activity (MVPA) may prevent or delay the onset of AD. Therefore, we evaluated the potential effectiveness of a remotely delivered home-based group exercise (≈8/group) to increase daily MVPA and cardiorespiratory fitness in adults with DS to a level that may be associated with delaying AD in adults with DS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>Adults with DS (<i>n</i> = 81, age ≈27 years 55% female) without dementia were randomized (2:2:1) to a 12-month intervention, which included 40-min exercise sessions scheduled once (remote low (RL), <i>n</i> = 32) or 3 times per week (remote high (RH), <i>n</i> = 34) plus twice monthly 20-min individual remotely delivered support/education sessions or to a control arm who attended twice monthly support/education sessions only (SE, <i>n</i> = 15). MVPA (minutes/day) was assessed by accelerometer, and cardiorespiratory fitness (VO<sub>2 Peak,</sub> mL/kg/min) was assessed using a maximal treadmill test</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> RESULTS</h3>\u0000 \u0000 <p>Participant retention at 12 months was 100%. Attendance at exercise and support/education sessions averaged ~85% and ~86%, respectively. Linear mixed modeling revealed no significant differences in change in MVPA from baseline to 12 months between the RH (10 min/day) and the RL arms (2 min/day, <i>p </i>= 0.06) or the RH and SE arms (1 min/day <i>p</i> = 0.13). The change in VO₂ <sub>Peak</sub> differed significantly between the RH (2.0 ± 4.6 mL/kg/min) and RL arms (−1.1 ± 3.0 mL/kg/min, <i>p</i> = 0.04) but not between the RH and SE arms (1.2 ± 5.3 mL/kg/min, <i>p </i>= 0.85).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> DISCUSSION</h3>\u0000 \u0000 <p>Our results suggest that remotely delivered group exercise (3 times/week) in conjunction with twice-monthly support/education is feasible and may increase daily MVPA and cardiorespiratory fitness to a level that may be associated with improvements in health and cognitive parameters in adults with DS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> CLINICAL TRIALS REGISTRATION</h3>\u0000 \u0000 <p>This trial was approved by the Institutional Review Board at the University of Kansas Medical Center and was registered on clinicaltrials.gov (NCT04048759).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 ","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70115","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144273125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The LATTICE Study: Design of a pilot feasibility randomized controlled trial of lithium to delay cognitive decline in mild cognitive impairment","authors":"Ariel G. Gildengers,&nbsp;Tamer S. Ibrahim,&nbsp;Xuemei Zeng,&nbsp;Howard J. Aizenstein,&nbsp;Salem K. Alkhateeb,&nbsp;Stewart J. Anderson,&nbsp;Cong Chu,&nbsp;Jihui L. Diaz,&nbsp;James E. Emanuel,&nbsp;Thomas K. Karikari,&nbsp;Jinghang Li,&nbsp;Oscar L. Lopez,&nbsp;Brian J. Lopresti,&nbsp;Sarah K. Royse,&nbsp;Andrea N. Sajewski,&nbsp;Tales Santini,&nbsp;Andrea M. Weinstein,&nbsp;Minjie Wu,&nbsp;Meryl A. Butters","doi":"10.1002/trc2.70112","DOIUrl":"https://doi.org/10.1002/trc2.70112","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> INTRODUCTION</h3>\u0000 \u0000 <p>Interest has grown in lithium's neuroprotective properties in neurodegenerative illnesses. We discuss the design, rationale, and implementation of a pilot feasibility, double-blind, randomized placebo-controlled trial (RCT) examining whether lithium can delay cognitive decline in older adults with mild cognitive impairment (MCI).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>The study launched in September 2017. The goal was to enroll 80 community-dwelling participants ≥ 60 years with MCI into an RCT in which they would participate for 2 years with baseline and follow-up assessment of cognition, brain imaging, and plasma-based biomarkers. Participants were randomized to lithium or placebo (1:1).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> RESULTS</h3>\u0000 \u0000 <p>We enrolled 80 MCI older adults into the RCT. Baseline characteristics included a mean (standard deviation) age of 72 (7.7) years with 35 male and 45 female participants. Seventy-five participants had positron emission tomography imaging for amyloid beta (Aβ), and 66 completed 7T magnetic resonance imaging. Twenty-one participants were Aβ+ and 54 were Aβ–.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> DISCUSSION</h3>\u0000 \u0000 <p>The study successfully enrolled 80 participants into an RCT examining whether lithium delays cognitive decline. The main study results will be forthcoming.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Clinical Trial Registration</h3>\u0000 \u0000 <p>NCT03185208.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>Eighty adults ≥ 60 years with mild cognitive impairment entered a placebo-controlled randomized controlled trial evaluating lithium's neuroprotective properties.</li>\u0000 \u0000 <li>Participants were followed for 2 years with baseline and follow-up evaluations at 1 and 2 years that included neurocognitive assessment, ultra-high-field structural neuroimaging, positron emission tomography imaging for amyloid beta and tau, and plasma-based biomarkers.</li>\u0000 \u0000 <li>Study results will be forthcoming.</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70112","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144256342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time saved in activities of daily living and whole-brain volume: Post hoc analysis of a randomized feasibility trial of gamma oscillation treatment in participants with mild or moderate Alzheimer's disease","authors":"Ralph Kern,&nbsp;Benjamin Haaland,&nbsp;Jessie Nicodemus-Johnson,&nbsp;Samuel Dickson,&nbsp;Matthew Morgan,&nbsp;Joshua R. Christensen,&nbsp;Marwan N. Sabbagh,&nbsp;Lily Lee,&nbsp;Mihaly Hajós,&nbsp;Julia Riddle,&nbsp;Chandran V. Seshagiri,&nbsp;Christian Howell,&nbsp;Craig Mallinckrodt,&nbsp;Suzanne Hendrix","doi":"10.1002/trc2.70118","DOIUrl":"https://doi.org/10.1002/trc2.70118","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; INTRODUCTION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Gamma oscillations in the brain are necessary for normal cognitive function, sensory processing, and memory consolidation, and are reduced in Alzheimer's disease (AD). In a 6 month, randomized, feasibility trial in participants with mild-to-moderate AD (OVERTURE [NCT03556280], &lt;i&gt;n&lt;/i&gt; = 76), a non-invasive method for sensory-evoked brain gamma oscillations outperformed sham on the secondary outcomes of slowing decline on the Alzheimer's Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) functional scale, magnetic resonance imaging measures of whole brain volume and the Mini-Mental State Examination (MMSE) cognitive outcome, despite not showing statistical significance on the primary outcome (Mild and Moderate Alzheimer's Disease Composite [MADCOMS]), a composite cognitive-functional score. In this post hoc analysis of OVERTURE, we evaluated the effects of investigational sensory-evoked gamma oscillation treatment in terms of time saved, as an estimate of slowing in disease progression, on ADCS-ADL, MMSE, and whole-brain volume.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; METHODS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Disease trajectories based on the ADCS-ADL, MMSE, and whole-brain volume changes from baseline within each treatment group were constructed using mixed-effects models. Horizontal projection from active to sham arm yielded time saved from baseline at each visit. Data from the open label extension (OLE) phase of the OVERTURE study have also been used to analyze the time-saving effect of active treatment in an extended period.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; RESULTS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Compared to sham, time savings of 4.83, 4.59, and 4.09 months over 6 months of active treatment on ADCS-ADL, MMSE, and whole-brain atrophy were observed in the randomized controlled trial phase. When including the OLE phase, time savings of 8.66, 10.00, and 7.48 months over 14.64, 15.98, and 13.46 months of active treatment on ADCS-ADL, MMSE, and whole-brain atrophy were observed relative to the sham group.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; DISCUSSION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;These findings suggest that further exploration of the effect of evoked gamma oscillations in participants with mild-to-moderate AD, as well as the evaluation of treatment effects using time saved, is merited.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Highlights&lt;/h3&gt;\u0000 \u0000 &lt;div&gt;\u0000 &lt;ul&gt;\u0000 \u0000 &lt;li&gt;Evoked gamma oscillation slows functional loss and brain atrophy in Alzheimer's ","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70118","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144255841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Translation with ongoing adaptation and improvement (ToAI) framework: A community-informed, structured, iterative approach to culturally adapting cognitive assessment tools","authors":"Quyen Q. Tiet,&nbsp;Sarah Tomaszewski Farias,&nbsp;Duyen Tran,&nbsp;Van T. Park,&nbsp;Brandon E. Gavett,&nbsp;Ladson Hinton,&nbsp;Lauren G. Mai,&nbsp;Christopher Nguyen,&nbsp;Rachel A. Whitmer,&nbsp;Quyen Vuong,&nbsp;Danielle Harvey,&nbsp;Oanh L. Meyer","doi":"10.1002/trc2.70105","DOIUrl":"https://doi.org/10.1002/trc2.70105","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> INTRODUCTION</h3>\u0000 \u0000 <p>Alzheimer's disease (AD) and related dementias (ADRD) are increasing globally, including in the United States, but the fast-growing Vietnamese American population remains understudied, with a significant lack of culturally adapted neuropsychological assessment tools. The Vietnamese Insights into Cognitive Aging Program (VIP) addresses this gap as the first longitudinal cohort study focused on this community.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>This paper (1) describes the assessment instruments, including a neuropsychological battery selected for the VIP, and (2) introduces the Translation with Ongoing Adaptation and Improvement (ToAI) framework, an innovative and practical method for culturally informed translation and adaptation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> RESULTS</h3>\u0000 \u0000 <p>The ToAI framework followed a nine-step process: preparation, translation, native-speaker review, VIP team review, external panel review, pilot testing, proofreading, final formatting, and ongoing review and improvement.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> DISCUSSION</h3>\u0000 \u0000 <p>The ToAI framework was efficient, and the ongoing improvement component was particularly beneficial. It is recommended for inclusion in future cross-cultural research involving translation and adaptation processes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>The Translation with Ongoing Adaptation and Improvement (ToAI) framework.</li>\u0000 \u0000 <li>Cross-cultural translation and adaptation of psychological assessment instruments.</li>\u0000 \u0000 <li>Neuropsychological assessment for Vietnamese American older adults.</li>\u0000 \u0000 <li>The Vietnamese Insights into Cognitive Aging Program (VIP).</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70105","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144255843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Programmatic research outcomes used to establish the evidence-base of dementia caregiving support programs: An analysis of Best Programs for Caregiving","authors":"Morgan J. Minyo,&nbsp;Sara M. Powers,&nbsp;David M. Bass,&nbsp;Rachel M. Cannon,&nbsp;Katie Maslow,&nbsp;Zoe F. Fete,&nbsp;Megan K. Huth","doi":"10.1002/trc2.70092","DOIUrl":"https://doi.org/10.1002/trc2.70092","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; INTRODUCTION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;A substantial number of evidence-based dementia caregiving support programs positively impact family and friend caregivers. Researchers and service organizations have successfully translated and delivered a subset of these programs to caregivers and are included in &lt;i&gt;Best Programs for Caregiving&lt;/i&gt; (BPC). This investigation examined the programmatic caregiver research outcomes reported in peer-reviewed articles of BPC programs to understand how programs impact caregivers in the community and identify underrepresented outcomes.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; METHODS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Peer-reviewed, published research articles that (1) reported at least one dementia caregiver outcome, and (2) used a controlled trial or pre/posttest study design were abstracted from the BPC database. Across 45 evidence-based programs in BPC, 128 articles met inclusion criteria for data coding and descriptive analysis. Research outcomes (e.g., stress, depressive symptoms), efficacy findings (e.g., beneficial, no effect), and the type of study design used (e.g., pre/posttest, treatment/control) were coded from each article.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; RESULTS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Twelve programmatic outcomes were identified focusing on &lt;i&gt;Caregiver Well-Being&lt;/i&gt; and &lt;i&gt;Caregiver Support&lt;/i&gt;. &lt;i&gt;Caregiver Well-Being&lt;/i&gt; outcomes were frequently assessed by BPC programs, including symptoms of depression, reported in 81 (63.3%) articles, and care-related stress, strain, and/or burden, reported in 75 (58.6%) articles. By comparison, &lt;i&gt;Caregiver Support&lt;/i&gt; outcomes were infrequently measured including quantity of family/friend support, reported in 17 (13.3%) articles, and quantity of community service use, reported in 13 (10.2%) articles. High percentages of beneficial findings were reported for both &lt;i&gt;Caregiver Well-Being&lt;/i&gt; and &lt;i&gt;Caregiver Support&lt;/i&gt; outcomes. Articles reported beneficial findings using pre/posttest and treatment/control group designs similarly across caregiver outcomes.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; DISCUSSION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The majority of BPC programs positively impact caregiver well-being outcomes but limited attention is given to other person-centered and strength-based research outcomes including supports for caregivers, unmet needs, and positive aspects of caregiving. Additional research is needed by both established and new non-pharmacological caregiving interventions to target and evaluate the impact of these underrepresented outcomes.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 ","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70092","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144255840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimating the optimal cutoff for the IGT-AD Distress subscale adapted for amyloid PET results disclosure","authors":"Dianxu Ren,&nbsp;Kim Jeong Eun,&nbsp;Joshua D. Grill,&nbsp;Jennifer H. Lingler","doi":"10.1002/trc2.70116","DOIUrl":"https://doi.org/10.1002/trc2.70116","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; INTRODUCTION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Research on diagnostic and biomarker disclosure has significantly increased, particularly in the field of Alzheimer's disease (AD). The psychological impact of learning amyloid positron emission tomography (PET) results has been frequently assessed using the Impact of Genetic Testing for Alzheimer's Disease (IGT-AD) instrument. Establishing an optimal cutoff score for this screening tool is essential for efficiently identifying individuals who may require psychological support after amyloid PET disclosure. In this study, we aimed to determine the optimal distress cutoff for the adapted IGT-AD instrument after amyloid PET result disclosure in cognitively symptomatic older adults.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; METHODS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We adapted the IGT-AD instrument by replacing reference to genetic testing with reference to amyloid PET testing. A total of 98 participants with either mild cognitive impairment (MCI) or dementia were assessed for psychological impact using this adapted instrument and the Impact of Event Scale (IES; cutoff = 26) as a gold standard. Receiver operating characteristic analysis determined the optimal distress cutoff, with the Youden index maximizing sensitivity and specificity. The area under the curve (AUC) was calculated to evaluate the predictive accuracy of the IGT-AD.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; RESULTS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The mean age of participants was 72.6 years, 41.8% were male, 77.6% were White, 16.3% were Black, and 15.3% were of Hispanic ethnicity. Most (57.2%) held bachelor or post-bachelor degrees, and 73.5% were married or cohabiting. The optimal cutoff point for the modified IGT-AD Distress subscale was determined to be 15, with a sensitivity of 100% and specificity of 70.1%. The AUC for distress was 0.89 (95% confidence interval: 0.82–0.95), indicating good predictive power.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; DISCUSSION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;A distress score ≥ 15 on the adapted IGT-AD appears to be a suitable cutoff for detecting significant psychological distress in cognitively symptomatic individuals learning their amyloid PET result. This cutoff has potential clinical and research applications for screening and early intervention.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Highlights&lt;/h3&gt;\u0000 \u0000 &lt;div&gt;\u0000 &lt;ul&gt;\u0000 \u0000 &lt;li&gt;The Impact of Genetic Testing for Alzheimer's Disease (IGT-AD) instrument is widely used to assess the psychological impact of Alzheimer's disease bio","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70116","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144232490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Profiling the needs of dementia caregivers in a Brazilian cross-sectional study","authors":"Alan Cronemberger Andrade,&nbsp;Mariel Carolina Montiel-Aponte,&nbsp;Ronaldo Cristiano Prati,&nbsp;Sheilla de Medeiros Correia Marin,&nbsp;Emanuela Bezerra Torres Mattos,&nbsp;Flavio Shigeo Yamamoto,&nbsp;Marcia Maria Pires Camargo Novelli,&nbsp;Walter Teixeira Lima Junior","doi":"10.1002/trc2.70067","DOIUrl":"https://doi.org/10.1002/trc2.70067","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; INTRODUCTION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Alzheimer's disease is an increasingly critical public health concern in aging populations. Characterized by progressive impairments, it can lead to dementia and significant dependence on family caregivers, who often face cognitive and behavioral challenges and heightened health risks. The study investigates the demands and unmet needs of these family caregivers using an electronic data-capture approach.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; METHODS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;This observational, descriptive, cross-sectional study was conducted in Brazil from February 2022 to January 2023. Non-professional dementia caregivers were surveyed through asynchronous digital data collection. A novel, context-specific questionnaire developed by an interdisciplinary expert group was administered, and a subset of randomly selected caregivers participated in focused interviews to enhance data quality.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; RESULTS&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Of 711 potential participants screened, 381 completed the questionnaire (53% response rate). Among them, 311 (82%) identified as non-professional caregivers. The results indicate that these caregivers often feel unprepared (46%), may have a negative self-perception of their role (39%), but also may feel rewarded with being a caregiver (44%). The primary needs expressed included additional assistance from others (87%) and emotional support (62%).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; DISCUSSION&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Findings indicate that care responsibilities were predominantly assumed by middle-aged female relatives, primarily in unpaid roles, with many providing more than 8 hours of direct care daily. A substantial proportion left their jobs to fulfill caregiving duties, underscoring the urgency of implementing policies that address the extensive needs of individuals with dementia and their caregivers. Given the complexity of dementia, public policies should be informed by rigorous situational analysis and delivered through targeted social, health, and educational programs that equip caregivers with effective management strategies and technologies while enhancing personalized emotional support systems.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Highlights&lt;/h3&gt;\u0000 \u0000 &lt;div&gt;\u0000 &lt;ul&gt;\u0000 \u0000 &lt;li&gt;Lack of preparedness: Brazilian family caregivers often feel unprepared for their responsibilities (33%), which may lead to negative self-satisfaction with their role as caregivers (38%).&lt;/li&gt;\u0000 ","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70067","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144213896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to “Evaluation of efficiency and effectiveness of different recruitment strategies for the FINGER-NL multidomain lifestyle intervention trial via the Dutch Brain Research Registry”","authors":"","doi":"10.1002/trc2.70082","DOIUrl":"https://doi.org/10.1002/trc2.70082","url":null,"abstract":"<p>Waterink L, Sikkes SAM, Soons LM, et al. Evaluation of efficiency and effectiveness of different recruitment strategies for the FINGER-NL multidomain lifestyle intervention trial via the Dutch Brain Research Registry <i>Alzheimer's Dement</i>. 2025;11(1):e70017. doi: 10.1002/trc2.70017.</p><p>In the Author list, the first and last name of the seventh author are reversed. This should have been:</p><p>Nynke Smidt (https://orcid.org/0000-0002-2778-8841)</p><p>We apologize for this error.</p>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70082","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144220252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing clinical meaningfulness in clinical trials for Alzheimer's disease: A U.S. regulatory perspective","authors":"Teresa Buracchio,&nbsp;Michelle Campbell,&nbsp;Kevin Krudys","doi":"10.1002/trc2.70113","DOIUrl":"https://doi.org/10.1002/trc2.70113","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <p>In the context of recent approvals of amyloid-directed monoclonal antibodies for the treatment of Alzheimer's disease (AD) by the United States (U.S.) Food and Drug administration (FDA), there has been much public discussion regarding the meaningfulness of the treatment effects demonstrated with these drugs in clinical trials. There are a variety of regulatory approaches to evaluate how results on a clinical endpoint reflect a meaningful effect of an intervention, including qualitative and quantitative methodologies. This article will discuss regulatory considerations for clinical benefit across the stages of AD, approaches to the assessment of clinical meaningfulness in clinical trials, and FDA's assessment of clinical benefit in the recent traditional approvals of amyloid-directed monoclonal antibodies for the treatment of AD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>Assessment of clinical benefit will depend on the stage of Alzheimer's disease (AD) being studied, the clinical symptoms or findings that occur at that stage of disease, and the mechanism of the drug and its anticipated effects.</li>\u0000 \u0000 <li>It is critical to obtain input from patients and caregivers with lived experience to understand their perspectives on clinical benefit.</li>\u0000 \u0000 <li>The Food and Drug Administration (FDA) encourages the use of clinically meaningful within-patient change, which captures the assessment of improvement or decline based on the perspective of the individual patient, to assess meaningful score differences.</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70113","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alzheimer's disease drug development pipeline: 2025","authors":"Jeffrey L. Cummings,&nbsp;Yadi Zhou,&nbsp;Garam Lee,&nbsp;Kate Zhong,&nbsp;Jorge Fonseca,&nbsp;Amanda M. Leisgang-Osse,&nbsp;Feixiong Cheng","doi":"10.1002/trc2.70098","DOIUrl":"https://doi.org/10.1002/trc2.70098","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <p>Clinical trials for Alzheimer's disease (AD) must be registered on clinicaltrials.gov. The registry presents a variety of types of information related to the planned clinical trial. We assess clinicaltrials.gov to document and compare aspects of drug development across the AD pipeline. Currently, there are 138 drugs being assessed in 182 clinical trials in the AD pipeline. Biological disease-targeted therapies (DTTs) comprise 30% of the pipeline; small molecule DTTs account for 43% of the pipeline; drugs addressing cognitive enhancement account for 14% of the pipeline; and drugs aiming to ameliorate neuropsychiatric symptoms in participants with AD contribute 11% of the pipeline. Biomarkers are among the primary outcomes of 27% of active trials. Repurposed agents represent 33% of the pipeline agents. The pipeline has more trials and more drugs compared to the 2024 pipeline.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>The 2025 Alzheimer's disease drug development pipeline hosts 182 trials and 138 novel drugs.</li>\u0000 \u0000 <li>The 2025 Alzheimer's disease drug development pipeline is diverse, with agents that address 15 basic disease processes.</li>\u0000 \u0000 <li>The 2025 Alzheimer's disease drug development pipeline has more trials and more drugs than the 2024 pipeline.</li>\u0000 \u0000 <li>Biomarkers play an important role in current trials to determine trial eligibility and as outcomes of trials.</li>\u0000 \u0000 <li>Repurposed agents comprise approximately one-third of the agents and trials in the 2025 Alzheimer's disease drug development pipeline.</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 2","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70098","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144197228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}