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2. Suicidal ideation and behavior assessment in dementia studies: An Internet survey

Author

Chappell, Phillip, Dubrava, Sarah, Stewart, Michelle, Hartley, Dean M, Alphs, Larry, Brashear, H Robert, Conwell, Yeates, Miller, David, Schindler, Rachel J, Siemers, Eric R, and Yaffe, Kristine

Subjects
Biomedical and Clinical Sciences, Neurosciences, Clinical Sciences, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Neurodegenerative, Prevention, Dementia, Brain Disorders, Alzheimer's Disease, Suicide Prevention, Aging, Mental Health, Serious Mental Illness, Clinical Research, Acquired Cognitive Impairment, Suicide, Behavioral and Social Science, Neurological, C-SSRS in dementia trials, Prospective assessment of suicidal ideation and behavior in dementia, Suicidal ideation and behavior in dementia clinical trials, Clinical sciences, Biological psychology
Abstract

INTRODUCTION:The AARR task force on suicidal ideation and behavior (SI/SB) in dementia conducted an online survey on the extent of SI/SB in individuals diagnosed with mild cognitive impairment (MCI) or dementia who were participating in clinical trials. METHODS:Investigators with experience in conducting SI/SB assessments in clinical trial subjects with MCI or dementia were invited to complete a global 19-item online survey. RESULTS:A total of 204 evaluable responses were collected with the majority from North America and Europe (83.4%) and the remainder from Asia, Latin America, and Mideast/Africa. The mean (SD) number of subjects personally assessed by the respondents in the past year with MCI, mild-moderate dementia, or severe dementia was 12.8 (26.2), 31.2 (39.6), and 10.1 (34.7), respectively. The mean number of subjects in each diagnostic group with suicidal ideation (SI), suicidal behavior (SB), or completed suicide (CS) was on average quite low (0.3 to 1.1 for SI, 0.1 to 0.2 for SB, and 0.0 to 0.2 for CS). Confidence in subject self-reports of SI/SB over different time periods declined with increasing severity of cognitive impairment and with increasing duration of the recall time period assessed. Of respondents, 56% and 75% had low confidence in self-ratings of SI/SB from subjects with severe dementia over the past 24 hours and the past week to 1 month, respectively. Ratings of the reliability of information collected on SI/SB also decreased with increasing severity of cognitive impairment. Approximately 70% of respondents rated the reliability of the information they obtained from all sources (patient, caregiver, and others) for subjects with MCI as high, but only about half (42.0% to 55.3%) and less than a quarter (17.4% to 24.3%) rated the reliability of information obtained for subjects with mild to moderate dementia or severe dementia as high, respectively. DISCUSSION:These results support the usefulness of prospective SI/SB assessments in MCI and mild dementia, raise questions about the reliability of assessments in moderate dementia, and confirm their lack of clinical utility in severe dementia. The results highlight the need for development of validated assessment instruments adapted to the stage of cognitive decline of the patients under study and may be the most effective in the earliest stages of the disease.

Published
2016

3. Considerations for the assessment of suicidal ideation and behavior in older adults with cognitive decline and dementia

Author

Alphs, Larry, Brashear, H Robert, Chappell, Phillip, Conwell, Yeates, Dubrava, Sarah, Khin, Ni A, Kozauer, Nicholas, Hartley, Dean M, Miller, David S, Schindler, Rachel J, Siemers, Eric R, Stewart, Michelle, and Yaffe, Kristine

Subjects
Biomedical and Clinical Sciences, Biological Psychology, Clinical Sciences, Neurosciences, Psychology, Dementia, Clinical Research, Brain Disorders, Mental Health, Aging, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Suicide Prevention, Neurodegenerative, Prevention, Suicide, Acquired Cognitive Impairment, Behavioral and Social Science, Alzheimer's Disease, Neurological, Cognitive impairment, Elderly, Suicidal behavior, Suicidal ideation, Suicidality, Suicide assessment, Suicide risk, Clinical sciences, Biological psychology
Abstract

INTRODUCTION:Better understanding of suicide risk and its management in older adults with cognitive impairment and/or dementia remain significant unmet public health needs. Urgency to address them derives from concern that CNS treatments for dementia may impact suicide risk. Regulatory guidances requiring assessment of emergent suicidal ideation and behavior (SI/SB) at every clinical trial visit emphasize the need for understanding their prevalence. METHODS:The literature regarding SI/SB in older persons with cognitive impairment or dementia was reviewed by an Alzheimer's Association Taskforce with emphasis on epidemiology, classification, assessment, and regulatory requirements. RESULTS:Gaps in our knowledge were identified, challenges discussed and recommendations for future work provided. DISCUSSION:Currently available SI/SB data from geriatric persons with dementia do not provide adequate understanding of its epidemiology, identification, assessment, or management. The growing public health burden of this population requires greater attention from clinicians and researchers on tactics and assessment tools to meet these needs.

Published
2016

4. Recruitment strategies and tactics for INTERCEPT‐AD: A phase I trial of Aβ oligomer‐targeting ACU193 in early Alzheimer’s disease

Author

Moxon, Robyn, primary, Feaster, Todd, additional, Carroll, Alyssa, additional, Gan, Siew Tin, additional, Ziemba, Shane, additional, Price, Kimber, additional, Skljarevski, Vladimir, additional, Sundell, Karen L, additional, Sethuraman, Gopalan, additional, Hitchcock, Janice, additional, and Siemers, Eric R, additional

Published
2023
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19. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: Recommendations from the Alzheimer’s Association Research Roundtable Workgroup

Author

Sperling, Reisa A., Jack, Clifford R., Jr., Black, Sandra E., Frosch, Matthew P., Greenberg, Steven M., Hyman, Bradley T., Scheltens, Philip, Carrillo, Maria C., Thies, William, Bednar, Martin M., Black, Ronald S., Brashear, H. Robert, Grundman, Michael, Siemers, Eric R., Feldman, Howard H., and Schindler, Rachel J.

Published
2011
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21. Evidence that semaphorin 4D is upregulated in neurons in Huntington’s and Alzheimer’s diseases: Effects of a SEMA4D blocking antibody on FDG‐PET in a clinical trial, and treatment rationale for its use in AD

Author

Evans, Elizabeth E., primary, Fisher, Terrence L., additional, Leonard, John E., additional, Reader, Alisha M., additional, Mishra, Vikas, additional, Mallow, Crystal L., additional, Balch, Leslie, additional, Howell, Alan, additional, Smith, Ernest S., additional, Feigin, Andrew, additional, Siemers, Eric R., additional, and Zauderer, Maurice, additional

Published
2020
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27. Modeling screening, prevention, and delaying of Alzheimer's disease: an early-stage decision analytic model

Author

Siemers Eric R, Kahle-Wrobleski Kristin, Klein Robert W, Furiak Nicolas M, Sarpong Eric, and Klein Timothy M

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Background Alzheimer's Disease (AD) affects a growing proportion of the population each year. Novel therapies on the horizon may slow the progress of AD symptoms and avoid cases altogether. Initiating treatment for the underlying pathology of AD would ideally be based on biomarker screening tools identifying pre-symptomatic individuals. Early-stage modeling provides estimates of potential outcomes and informs policy development. Methods A time-to-event (TTE) simulation provided estimates of screening asymptomatic patients in the general population age ≥55 and treatment impact on the number of patients reaching AD. Patients were followed from AD screen until all-cause death. Baseline sensitivity and specificity were 0.87 and 0.78, with treatment on positive screen. Treatment slowed progression by 50%. Events were scheduled using literature-based age-dependent incidences of AD and death. Results The base case results indicated increased AD free years (AD-FYs) through delays in onset and a reduction of 20 AD cases per 1000 screened individuals. Patients completely avoiding AD accounted for 61% of the incremental AD-FYs gained. Total years of treatment per 1000 screened patients was 2,611. The number-needed-to-screen was 51 and the number-needed-to-treat was 12 to avoid one case of AD. One-way sensitivity analysis indicated that duration of screening sensitivity and rescreen interval impact AD-FYs the most. A two-way sensitivity analysis found that for a test with an extended duration of sensitivity (15 years) the number of AD cases avoided was 6,000-7,000 cases for a test with higher sensitivity and specificity (0.90,0.90). Conclusions This study yielded valuable parameter range estimates at an early stage in the study of screening for AD. Analysis identified duration of screening sensitivity as a key variable that may be unavailable from clinical trials.

Published
2010
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28. IC‐P‐216: LOBAR CLASSIFICATION OF TAU PET IMAGES IN THE EXPEDITION‐3 TRIAL

Author

Shcherbinin, Sergey, primary, Liu, Peng, additional, Fleisher, Adam S., additional, Sundell, Karen L., additional, Charil, Arnaud, additional, Lu, Ming, additional, Devous, Michael D., additional, Pontecorvo, Michael J., additional, Mintun, Mark A., additional, Siemers, Eric R., additional, Irizarry, Michael C., additional, and Schwarz, Adam J., additional

Published
2018
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29. O3‐13‐02: LOBAR CLASSIFICATION OF TAU PET IMAGES IN THE EXPEDITION‐3 TRIAL

Author

Shcherbinin, Sergey, primary, Liu, Peng, additional, Fleisher, Adam S., additional, Sundell, Karen L., additional, Charil, Arnaud, additional, Lu, Ming, additional, Devous, Michael D., additional, Pontecorvo, Michael J., additional, Mintun, Mark A., additional, Siemers, Eric R., additional, Irizarry, Michael C., additional, and Schwarz, Adam J., additional

Published
2018
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30. Derivation of cutoffs for the Elecsys ® amyloid β (1–42) assay in Alzheimer's disease

Author

Shaw, Leslie M., primary, Waligorska, Teresa, additional, Fields, Leona, additional, Korecka, Magdalena, additional, Figurski, Michal, additional, Trojanowski, John Q., additional, Eichenlaub, Udo, additional, Wahl, Simone, additional, Quan, Marian, additional, Pontecorvo, Michael J., additional, Lachno, D. Richard, additional, Talbot, Jayne A., additional, Andersen, Scott W., additional, Siemers, Eric R., additional, and Dean, Robert A., additional

Published
2018
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31. Topline results of INTERCEPT‐AD: A phase I trial of Aβ oligomer‐targeting ACU193 in early Alzheimer's disease.

Author

Siemers, Eric R, Feaster, Todd, Skljarevski, Vladimir, Sundell, Karen L, Sethuraman, Gopalan, and Johnson, Kimball

Abstract

Background: ACU193 is a humanized IgG2 subclass monoclonal antibody targeting soluble amyloid‐beta oligomers (sAβOs). Growing evidence supports the view that sAβOs may be the most toxic and pathogenic form of Aβ relative to Aβ monomers and amyloid plaques and are one of the primary drivers of Alzheimer's disease (AD) neurodegeneration. Thus, blocking the toxicity of sAβOs with ACU193 is a promising approach for treating AD. Method: INTERCEPT‐AD is a phase 1 randomized, placebo‐controlled, single‐ and multiple‐ ascending dose (SAD/MAD) study of the safety, tolerability, and pharmacokinetics (PK) of intravenous ACU193 in participants with early AD, i.e., mild cognitive impairment or mild dementia due to AD. Key inclusion criteria are 55‐90 years of age, confirmation of amyloid pathology with a PET scan, MMSE score of 18‐30, and CDR‐Global score (CDR‐GS) of 0.5 or 1.0. The MAD portion of the study includes three administrations of ACU193 at doses of 10, 25, or 60 mg/kg. In addition to standard safety measures, MRI is assessed periodically. Cerebrospinal fluid is collected to assess PK and evidence of target engagement. The study also includes exploratory measures such as standard cognitive and functional assessments, a computerized cognitive test battery, measures of cerebral blood flow via arterial spin labeling on MRI, and various plasma biomarkers. Result: Sixty‐five participants from 17 U.S. study sites were randomized to INTERCEPT‐AD, with 53% female and baseline age of 72.1 ± 7.8 years (mean ± SD). The baseline MMSE was 24.2 ± 3.6, CDR‐GS was 0.64 ± 0.27, and CDR‐Sum of Boxes was 3.5 ± 1.8. In addition to baseline characteristics, the presentation will provide topline safety results, frequency of amyloid‐related imaging abnormalities (ARIA), PK assessments, and evidence of target engagement. Some exploratory measures including cognitive and functional assessments, computerized cognitive testing, and endpoint florbetapir PET results will also be presented. Conclusion: We will present topline results, along with key baseline demographic, clinical, and cognitive characteristics of participants in the INTERCEPT‐AD trial. The data generated from this trial will guide further development of ACU193 in a subsequent trial to test the novel mechanism of action of ACU193 in the treatment of early AD. [ABSTRACT FROM AUTHOR]

Published
2023
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32. [P1-049]: SOLANEZUMAB CENTRAL TARGET ENGAGEMENT AND PHARMACODYNAMIC ACTIVITY IN THE EXPEDITION 3 TRIAL OF PATIENTS WITH MILD AD: COMPARISON TO EXPEDITION/EXPEDITION 2

Author

Dean, Robert A., primary, Sundell, Karen L., additional, Lachno, David Richard, additional, Ferguson-Sells, Lisa R., additional, Case, Michael G., additional, Holdridge, Karen C., additional, Demattos, Ronald B., additional, Raskin, Joel, additional, Siemers, Eric R., additional, and Willis, Brian A., additional

Published
2017
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36. THE PATIENT VOICE: EXPLORING TREATMENT PREFERENCES IN PARTICIPANTS WITH MILD COGNITIVE CONCERNS TO INFORM REGULATORY DECISION MAKING

Author

Mansfield, Carol, primary, Bullok, Kristin E., additional, Fuhs, Jillian V., additional, Kahle-Wrobleski, Kristin, additional, Tockhorn-Heidenreich, Antje, additional, Andrews, Jeffrey Scott, additional, DiBenedetti, Dana B., additional, Matthews, Brandy R., additional, Darling, Joshua C., additional, Siemers, Eric R., additional, and Hauber, A. Brett, additional

Published
2017
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41. [P1-044]: SAFETY OF SOLANEZUMAB IN PHASE 3 STUDIES IN INDIVIDUALS WITH MILD ALZHEIMER's DISEASE DEMENTIA

Author

Carlson, Christopher D., primary, Anglin, Greg, additional, Case, Michael G., additional, Crowe, Brenda, additional, Hake, Ann Marie, additional, Khanna, Rashna, additional, Kryzhanovskaya, Ludmila, additional, Perahia, David, additional, Sethuraman, Gopalan, additional, Yaari, Roy, additional, Dowsett, Sherie A., additional, and Siemers, Eric R., additional

Published
2017
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42. [FTS3–02–01]: 2017 NIA‐AA RESEARCH FRAMEWORK TO INVESTIGATE THE ALZHEIMER's DISEASE CONTINUUM

Author

Jack, Clifford R., primary, Bennett, David A., additional, Blennow, Kaj, additional, Carrillo, Maria C., additional, Dunn, Billy, additional, Elliott, Cerise L., additional, Haeberlein, Samantha Budd, additional, Holtzman, David M., additional, Jagust, William J., additional, Jessen, Frank, additional, Karlawish, Jason, additional, Liu, Enchi, additional, Molinuevo, José Luis, additional, Montine, Thomas J., additional, Phelps, Creighton, additional, Rankin, Katherine, additional, Rowe, Christopher C., additional, Ryan, Laurie M., additional, Scheltens, Philip, additional, Siemers, Eric R., additional, Silverberg, Nina, additional, Snyder, Heather M., additional, and Sperling, Reisa A., additional

Published
2017
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43. PET BIOMARKERS IN THE EXPEDITION 3 TRIAL OF PATIENTS WITH MILD AD

Author

Mintun, Mark A., primary, Devous, Michael D., additional, Lu, Ming, additional, Pontecorvo, Michael J., additional, Joshi, Abhinay D., additional, Southekal, Sudeepti, additional, Siderowf, Andrew, additional, Lowrey, Mark, additional, Devine, Marybeth, additional, Benedum, Tyler E., additional, Pearson, Caitlin, additional, Lim, Nathaniel C., additional, Case, Michael G., additional, Sundell, Karen L., additional, and Siemers, Eric R., additional

Published
2017
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44. [P4–155]: DERIVING A CUT‐OFF FOR THE ELECSYS® β‐AMYLOID (1–42) IMMUNOASSAY FOR USE IN CLINICAL TRIALS SUPPORTED BY ELI LILLY FOR PATIENTS WITH CLINICALLY DEFINED ALZHEIMER's DISEASE (AD)

Author

Shaw, Leslie M., primary, Waligorska, Teresa, additional, Fields, Leona, additional, Korecka, Magdalena, additional, Figurski, Michal J., additional, Trojanowski, John Q., additional, Eichenlaub, Udo, additional, Wahl, Simone, additional, Quan, Marian, additional, Lachno, David Richard, additional, Talbot, Jayne A., additional, Andersen, Scott W., additional, Siemers, Eric R., additional, and Dean, Robert A., additional

Published
2017
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47. P4-127: Exploring the Utility of CSF Neurogranin Levels in An Alzheimer’s Disease Clinical Trial

Author

Dage, Jeffrey L., primary, Castelluccio, Peter F., additional, Anderson, Wesley, additional, Yu, Peng, additional, Talbot, Jayne, additional, Miller, Bradley B., additional, Herries, Elizabeth M., additional, Crimmins, Dan, additional, Ladenson, Jack H., additional, Fagan, Anne M., additional, Holtzman, David M., additional, Henley, David B., additional, Siemers, Eric R., additional, and Dean, Robert A., additional

Published
2016
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