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  1. Article ; Online: Plasma Apolipoprotein E Levels and Risk of Dementia-You Are the Company You Keep.

    Thambisetty, Madhav

    JAMA network open

    2020  Volume 3, Issue 7, Page(s) e209501

    MeSH term(s) Apolipoproteins ; Dementia/epidemiology ; Humans ; Lipoproteins ; Plasma
    Chemical Substances Apolipoproteins ; Lipoproteins
    Language English
    Publishing date 2020-07-01
    Publishing country United States
    Document type Journal Article ; Comment
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2020.9501
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  2. Article ; Online: Lecanemab and APOE Genotyping in Clinical Practice-Navigating Uncharted Terrain.

    Thambisetty, Madhav / Howard, Robert

    JAMA neurology

    2023  Volume 80, Issue 5, Page(s) 431–432

    MeSH term(s) Humans ; Genotype ; Genetic Testing ; Apolipoproteins E/genetics ; Alzheimer Disease/genetics ; Apolipoprotein E4
    Chemical Substances lecanemab (12PYH0FTU9) ; Apolipoproteins E ; Apolipoprotein E4
    Language English
    Publishing date 2023-03-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2702023-X
    ISSN 2168-6157 ; 2168-6149
    ISSN (online) 2168-6157
    ISSN 2168-6149
    DOI 10.1001/jamaneurol.2023.0207
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  3. Article ; Online: Lecanemab trial in AD brings hope but requires greater clarity.

    Thambisetty, Madhav / Howard, Robert

    Nature reviews. Neurology

    2023  Volume 19, Issue 3, Page(s) 132–133

    MeSH term(s) Humans ; Alzheimer Disease/drug therapy ; Clinical Trials as Topic ; Antibodies, Monoclonal, Humanized/therapeutic use
    Chemical Substances lecanemab (12PYH0FTU9) ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2023-01-03
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 2491514-2
    ISSN 1759-4766 ; 1759-4758
    ISSN (online) 1759-4766
    ISSN 1759-4758
    DOI 10.1038/s41582-022-00768-w
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  4. Article ; Online: Understanding mechanisms and seeking cures for Alzheimer's disease: why we must be "extraordinarily diverse".

    Thambisetty, Madhav

    American journal of physiology. Cell physiology

    2017  Volume 313, Issue 4, Page(s) C353–C361

    Abstract: After more than a century since Dr. Alois Alzheimer first described the pathological hallmarks accompanying the defining clinical features of the disease, we have yet to deliver any meaningful disease-modifying treatments to our patients. In this article, ...

    Abstract After more than a century since Dr. Alois Alzheimer first described the pathological hallmarks accompanying the defining clinical features of the disease, we have yet to deliver any meaningful disease-modifying treatments to our patients. In this article, I present a rationale for the need to be "extraordinarily diverse" in seeking effective ways to treat or prevent this devastating disease. This approach is based on applying a systems-biology perspective at the population level, using a diverse array of "OMICS" methodologies to identify molecular mechanisms associated with well-established AD risk factors including systemic inflammation, obesity, and insulin resistance. We believe that applying this strategy to understand longitudinal changes in human physiology during aging is of paramount importance in identifying meaningful opportunities to intervene effectively in AD.
    MeSH term(s) Aging/metabolism ; Aging/pathology ; Alzheimer Disease/metabolism ; Alzheimer Disease/pathology ; Alzheimer Disease/therapy ; Animals ; Brain/metabolism ; Disease Progression ; Humans ; Models, Neurological ; Molecular Targeted Therapy/trends ; Nerve Tissue Proteins/metabolism
    Chemical Substances Nerve Tissue Proteins
    Language English
    Publishing date 2017-06-14
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 392098-7
    ISSN 1522-1563 ; 0363-6143
    ISSN (online) 1522-1563
    ISSN 0363-6143
    DOI 10.1152/ajpcell.00111.2017
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  5. Article ; Online: How can secondary dementia prevention trials of Alzheimer's disease be clinically meaningful?

    Liu, Kathy Y / Thambisetty, Madhav / Howard, Robert

    Alzheimer's & dementia : the journal of the Alzheimer's Association

    2022  

    Abstract: After clinical trial failures in symptomatic Alzheimer's disease (AD), our field has moved to earlier intervention in cognitively normal individuals with biomarker evidence of AD. This offers potential for dementia prevention, but mainly low and variable ...

    Abstract After clinical trial failures in symptomatic Alzheimer's disease (AD), our field has moved to earlier intervention in cognitively normal individuals with biomarker evidence of AD. This offers potential for dementia prevention, but mainly low and variable rates of progression to AD dementia reduce the usefulness of trials' data in decision making by potential prescribers. With results from several Phase 3 secondary prevention studies anticipated within the next few years and the Food and Drug Administration's recent endorsement of amyloid beta as a surrogate outcome biomarker for AD clinical trials, it is time to question the clinical significance of changes in biomarkers, adequacy of current trial durations, and criteria for treatment success if cognitively unimpaired patients and their doctors are to meaningfully evaluate the potential value of new agents. We argue for a change of direction toward trial designs that can unambiguously inform clinical decision making about dementia risk and progression.
    Language English
    Publishing date 2022-09-26
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2211627-8
    ISSN 1552-5279 ; 1552-5260
    ISSN (online) 1552-5279
    ISSN 1552-5260
    DOI 10.1002/alz.12788
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  6. Article ; Online: Computational Approaches to Assess Abnormal Metabolism in Alzheimer's Disease Using Transcriptomics.

    Lüleci, Hatice Büşra / Uzuner, Dilara / Çakır, Tunahan / Thambisetty, Madhav

    Methods in molecular biology (Clifton, N.J.)

    2022  Volume 2561, Page(s) 173–189

    Abstract: Transcriptome-integrated human genome-scale metabolic models (GEMs) have been used widely to assess alterations in metabolism in response to disease. Transcriptome integration leads to identification of metabolic reactions that are differentially ... ...

    Abstract Transcriptome-integrated human genome-scale metabolic models (GEMs) have been used widely to assess alterations in metabolism in response to disease. Transcriptome integration leads to identification of metabolic reactions that are differentially inactivated in the tissue of interest. Among the methods available for mapping transcriptome data on GEMs, we focus here on an Integrative Metabolic Analysis Tool (iMAT), which we have recently applied to the analysis of Alzheimer's disease (AD). We provide a detailed protocol for applying iMAT to create models of personalized metabolic networks, which can be further processed to identify reactions associated with abnormal metabolism.
    MeSH term(s) Humans ; Transcriptome ; Alzheimer Disease/diagnosis ; Alzheimer Disease/genetics ; Alzheimer Disease/metabolism ; Models, Biological ; Metabolic Networks and Pathways/genetics ; Genome, Human
    Language English
    Publishing date 2022-11-18
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Intramural
    ISSN 1940-6029
    ISSN (online) 1940-6029
    DOI 10.1007/978-1-0716-2655-9_9
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  7. Article ; Online: Alzheimer's drugs: Does reducing amyloid work?

    Thambisetty, Madhav / Howard, Robert / Glymour, M Maria / Schneider, Lon S

    Science (New York, N.Y.)

    2021  Volume 374, Issue 6567, Page(s) 544–545

    MeSH term(s) Alzheimer Disease/drug therapy ; Amyloid ; Amyloid beta-Peptides ; Amyloidogenic Proteins ; Humans ; Pharmaceutical Preparations
    Chemical Substances Amyloid ; Amyloid beta-Peptides ; Amyloidogenic Proteins ; Pharmaceutical Preparations
    Language English
    Publishing date 2021-10-28
    Publishing country United States
    Document type Letter ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 128410-1
    ISSN 1095-9203 ; 0036-8075
    ISSN (online) 1095-9203
    ISSN 0036-8075
    DOI 10.1126/science.abl8366
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  8. Article ; Online: Key questions for the evaluation of anti-amyloid immunotherapies for Alzheimer's disease.

    Liu, Kathy Y / Villain, Nicolas / Ayton, Scott / Ackley, Sarah F / Planche, Vincent / Howard, Robert / Thambisetty, Madhav

    Brain communications

    2023  Volume 5, Issue 3, Page(s) fcad175

    Abstract: The clinical benefit associated with anti-amyloid immunotherapies, a new class of drugs for the treatment of Alzheimer's disease, is predicated on their ability to modify disease course by lowering brain amyloid levels. At the time of writing, two ... ...

    Abstract The clinical benefit associated with anti-amyloid immunotherapies, a new class of drugs for the treatment of Alzheimer's disease, is predicated on their ability to modify disease course by lowering brain amyloid levels. At the time of writing, two amyloid-lowering antibodies, aducanumab and lecanemab, have obtained United States Food and Drug Administration accelerated approval, with further agents of this class in the Alzheimer's disease treatment pipeline. Based on limited published clinical trial data to date, regulators, payors and physicians will need to assess their efficacy, clinical effectiveness and safety, as well as cost and accessibility. We propose that attention to three important questions related to treatment efficacy, clinical effectiveness and safety should guide evidence-based consideration of this important class of drugs. These are: (1) Were trial statistical analyses appropriate and did they convincingly support claims of efficacy? (2) Do reported treatment effects outweigh safety concerns and are they generalizable to a representative clinical population of people with Alzheimer's disease? and (3) Do the data convincingly demonstrate disease course modification, suggesting that increasing clinical benefits beyond the duration of the trials are likely? We suggest specific approaches to interpreting trial results for these drugs and highlight important areas of uncertainty where additional data and a cautious interpretation of existing results is warranted. Safe, effective and accessible treatments for Alzheimer's disease are eagerly awaited by millions of patients and their caregivers worldwide. While amyloid-targeting immunotherapies may be promising disease-modifying Alzheimer's disease treatments, rigorous and unbiased assessment of clinical trial data is critical to regulatory decision-making and subsequently determining their provision and utility in routine clinical practice. Our recommendations provide a framework for evidence-based appraisal of these drugs by regulators, payors, physicians and patients.
    Language English
    Publishing date 2023-06-02
    Publishing country England
    Document type Journal Article ; Review
    ISSN 2632-1297
    ISSN (online) 2632-1297
    DOI 10.1093/braincomms/fcad175
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  9. Article ; Online: Unbiased proteomics and multivariable regularized regression techniques identify SMOC1, NOG, APCS, and NTN1 in an Alzheimer's disease brain proteomic signature.

    Roberts, Jackson A / Varma, Vijay R / Candia, Julián / Tanaka, Toshiko / Ferrucci, Luigi / Bennett, David A / Thambisetty, Madhav

    npj aging

    2023  Volume 9, Issue 1, Page(s) 18

    Abstract: Advancements in omics methodologies have generated a wealth of high-dimensional Alzheimer's disease (AD) datasets, creating significant opportunities and challenges for data interpretation. In this study, we utilized multivariable regularized regression ... ...

    Abstract Advancements in omics methodologies have generated a wealth of high-dimensional Alzheimer's disease (AD) datasets, creating significant opportunities and challenges for data interpretation. In this study, we utilized multivariable regularized regression techniques to identify a reduced set of proteins that could discriminate between AD and cognitively normal (CN) brain samples. Utilizing eNetXplorer, an R package that tests the accuracy and significance of a family of elastic net generalized linear models, we identified 4 proteins (SMOC1, NOG, APCS, NTN1) that accurately discriminated between AD (n = 31) and CN (n = 22) middle frontal gyrus (MFG) tissue samples from Religious Orders Study participants with 83 percent accuracy. We then validated this signature in MFG samples from Baltimore Longitudinal Study of Aging participants using leave-one-out logistic regression cross-validation, finding that the signature again accurately discriminated AD (n = 31) and CN (n = 19) participants with a receiver operating characteristic curve area under the curve of 0.863. These proteins were strongly correlated with the burden of neurofibrillary tangle and amyloid pathology in both study cohorts. We additionally tested whether these proteins differed between AD and CN inferior temporal gyrus (ITG) samples and blood serum samples at the time of AD diagnosis in ROS and BLSA, finding that the proteins differed between AD and CN ITG samples but not in blood serum samples. The identified proteins may provide mechanistic insights into the pathophysiology of AD, and the methods utilized in this study may serve as the basis for further work with additional high-dimensional datasets in AD.
    Language English
    Publishing date 2023-07-06
    Publishing country England
    Document type Journal Article
    ISSN 2731-6068
    ISSN (online) 2731-6068
    DOI 10.1038/s41514-023-00112-6
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  10. Article ; Online: Genetic Variation in Targets of Antidiabetic Drugs and Alzheimer Disease Risk: A Mendelian Randomization Study.

    Tang, Bowen / Wang, Yunzhang / Jiang, Xia / Thambisetty, Madhav / Ferrucci, Luigi / Johnell, Kristina / Hägg, Sara

    Neurology

    2022  Volume 99, Issue 7, Page(s) e650–e659

    Abstract: Background and objectives: Previous studies have highlighted antidiabetic drugs as repurposing candidates for Alzheimer disease (AD), but the disease-modifying effects are still unclear.: Methods: A 2-sample mendelian randomization study design was ... ...

    Abstract Background and objectives: Previous studies have highlighted antidiabetic drugs as repurposing candidates for Alzheimer disease (AD), but the disease-modifying effects are still unclear.
    Methods: A 2-sample mendelian randomization study design was applied to examine the association between genetic variation in the targets of 4 antidiabetic drug classes and AD risk. Genetic summary statistics for blood glucose were analyzed using UK Biobank data of 326,885 participants, whereas summary statistics for AD were retrieved from previous genome-wide association studies comprising 24,087 clinically diagnosed AD cases and 55,058 controls. Positive control analysis on type 2 diabetes mellitus (T2DM), insulin secretion, insulin resistance, and obesity-related traits was conducted to validate the selection of instrumental variables.
    Results: In the positive control analysis, genetic variation in sulfonylurea targets was associated with higher insulin secretion, a lower risk of T2DM, and an increment in body mass index, waist circumference, and hip circumference, consistent with drug mechanistic actions and previous trial evidence. In the primary analysis, genetic variation in sulfonylurea targets was associated with a lower risk of AD (odds ratio [OR] = 0.38 per 1 mmol/L decrement in blood glucose, 95% CI 0.19-0.72,
    Discussion: Genetic variation in sulfonylurea targets was associated with a lower risk of AD, and future studies are warranted to clarify the underlying mechanistic pathways between sulfonylureas and AD.
    MeSH term(s) Alzheimer Disease/complications ; Alzheimer Disease/drug therapy ; Alzheimer Disease/genetics ; Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/genetics ; Drug Repositioning ; Genome-Wide Association Study ; Glucagon-Like Peptide 1/therapeutic use ; Humans ; Hypoglycemic Agents/therapeutic use ; Mendelian Randomization Analysis ; Polymorphism, Single Nucleotide/genetics
    Chemical Substances Blood Glucose ; Hypoglycemic Agents ; Glucagon-Like Peptide 1 (89750-14-1)
    Language English
    Publishing date 2022-06-02
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 207147-2
    ISSN 1526-632X ; 0028-3878
    ISSN (online) 1526-632X
    ISSN 0028-3878
    DOI 10.1212/WNL.0000000000200771
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