US 3419578A
· Fitzmaurice et al.
· 1968
[cited by applicant]
US 3634582A
· Hartley et al.
· 1972
[cited by applicant]
US 3686412A
· Fitzmaurice et al.
· 1972
[cited by applicant]
US 3957965A
· Hartley et al.
· 1976
[cited by applicant]
US 4120285A
· Nugent
· 1978
[cited by applicant]
US 4405598A
· Brown
· 1983
[cited by applicant]
US 4405735A
· Wiezer et al.
· 1983
[cited by applicant]
US 4429545A
· Steinberg
· 1984
[cited by applicant]
US 4481206A
· Spiegel et al.
· 1984
[cited by applicant]
US 4996296A
· Pecht et al.
· 1991
[cited by applicant]
US 5376386A
· Ganderton et al.
· 1994
[cited by applicant]
US 5567720A
· Averback
· 1996
[cited by applicant]
US 5594142A
· Gaa et al.
· 1997
[cited by applicant]
US 5655523A
· Hodson et al.
· 1997
[cited by applicant]
US 5830920A
· Chucholowski et al.
· 1998
[cited by applicant]
US 5904937A
· Augello et al.
· 1999
[cited by applicant]
US 6168776B1
· Klunk et al.
· 2001
[cited by applicant]
US 6197963B1
· Hirschmann et al.
· 2001
[cited by applicant]
US 6309623B1
· Weers et al.
· 2001
[cited by applicant]
US 6696039B2
· Kung et al.
· 2004
[cited by applicant]
US 6911466B2
· Koo et al.
· 2005
[cited by applicant]
US 6946116B2
· Kung et al.
· 2005
[cited by applicant]
US 6972127B2
· Schenk
· 2005
[cited by applicant]
US 7160559B1
· McGee et al.
· 2007
[cited by applicant]
US 7186401B2
· Keller et al.
· 2007
[cited by applicant]
US 7858803B2
· Elmaleh et al.
· 2010
[cited by applicant]
US 8381454B1
· Robinson
· 2013
[cited by applicant]
US 8613920B2
· Lieberburg et al.
· 2013
[cited by applicant]
US 8617517B2
· Elmaleh et al.
· 2013
[cited by applicant]
US 8765742B2
· Hilifiker et al.
· 2014
[cited by applicant]
US 9283230B2
· Clunas et al.
· 2016
[cited by applicant]
US 9855276B2
· Elmaleh
· 2018
[cited by applicant]
US 9861608B2
· Elmaleh et al.
· 2018
[cited by applicant]
US 9913847B2
· Elmaleh
· 2018
[cited by applicant]
US 9918992B2
· Elmaleh
· 2018
[cited by applicant]
US 9925282B2
· Elmaleh et al.
· 2018
[cited by applicant]
US 9968618B1
· Elmaleh
· 2018
[cited by applicant]
US 20020009491A1
· Rothbard et al.
· 2002
[cited by applicant]
US 20020016359A1
· Hellberg et al.
· 2002
[cited by applicant]
US 20020091100A1
· Lezdey et al.
· 2002
[cited by applicant]
US 20020107173A1
· Friedhoff et al.
· 2002
[cited by applicant]
US 20040223918A1
· Pham et al.
· 2004
[cited by applicant]
US 20040259952A1
· Abbas et al.
· 2004
[cited by applicant]
US 20060142241A1
· Yoo
· 2006
[cited by applicant]
US 20060159629A1
· Tarara et al.
· 2006
[cited by applicant]
US 20060240007A1
· Sanders
· 2006
[cited by applicant]
US 20060276455A1
· Lindsberg et al.
· 2006
[cited by applicant]
US 20070015813A1
· Carter et al.
· 2007
[cited by applicant]
US 20070053843A1
· Dawson et al.
· 2007
[cited by applicant]
US 20070071690A1
· Mueller-Walz et al.
· 2007
[cited by applicant]
US 20070086981A1
· Meijer et al.
· 2007
[cited by applicant]
US 20070093457A1
· Arber et al.
· 2007
[cited by applicant]
US 20070178166A1
· Bernstein et al.
· 2007
[cited by applicant]
US 20070293538A1
· Hobden
· 2007
[cited by applicant]
US 20080021085A1
· Koo et al.
· 2008
[cited by applicant]
US 20090110679A1
· Li et al.
· 2009
[cited by applicant]
US 20090155256A1
· Black et al.
· 2009
[cited by applicant]
US 20100113613A1
· McLaurin et al.
· 2010
[cited by applicant]
US 20100143251A1
· Tamagnan et al.
· 2010
[cited by applicant]
US 20100173960A1
· Cruz et al.
· 2010
[cited by applicant]
US 20100236550A1
· Zeng et al.
· 2010
[cited by applicant]
US 20110129530A1
· Venkatesh et al.
· 2011
[cited by applicant]
US 20110262442A1
· Hamilton et al.
· 2011
[cited by applicant]
US 20120082727A1
· Cocconi et al.
· 2012
[cited by applicant]
US 20120121656A1
· Watson et al.
· 2012
[cited by applicant]
US 20120134929A1
· McGrath et al.
· 2012
[cited by applicant]
US 20120165366A1
· Ibrahim et al.
· 2012
[cited by applicant]
US 20120175082A1
· Kmetovicz et al.
· 2012
[cited by applicant]
US 20120308613A1
· Staniforth et al.
· 2012
[cited by applicant]
US 20150224077A1
· Gerhart et al.
· 2015
[cited by applicant]
US 20150224078A1
· Gerhart et al.
· 2015
[cited by applicant]
US 20150274680A1
· Ueda et al.
· 2015
[cited by applicant]
US 20160158150A1
· Morton et al.
· 2016
[cited by applicant]
US 20160166534A1
· Elmaleh
· 2016
[cited by applicant]
US 20160310503A1
· Elmaleh
· 2016
[cited by applicant]
US 20180344682A1
· Elmaleh
· 2018
[cited by applicant]
US 20200338040A1
· Elmaleh
· 2020
[cited by applicant]
US 20200383908A1
· Elmaleh
· 2020
[cited by applicant]
US 20210023010A1
· Elmaleh et al.
· 2021
[cited by applicant]
US 20210059977A1
· Elmaleh
· 2021
[cited by applicant]
US 20220125753A1
· Elmaleh
· 2022
[cited by applicant]
US 20220193087A1
· Elmaleh
· 2022
[cited by applicant]
US 20220218652A1
· Elmaleh et al.
· 2022
[cited by applicant]
US 20230226017A1
· Elmaleh
· 2023
[cited by applicant]
US 20230248646A1
· Elmaleh
· 2023
[cited by applicant]
US 20230248650A1
· Elmaleh et al.
· 2023
[cited by applicant]
US 20240082207A1
· Elmaleh
· 2024
[cited by applicant]
CA 2408793A1
· 2001
[cited by applicant]
CN 101754746A
· 2010
[cited by applicant]
CN 101848733A
· 2010
[cited by applicant]
CN 103347500A
· 2013
[cited by applicant]
CN 105377037A
· 2016
[cited by applicant]
CN 108164409A
· 2018
[cited by applicant]
CN 108403708A
· 2018
[cited by applicant]
DE 1543579
· 2005
[cited by applicant]
EP 1632242A2
· 2006
[cited by applicant]
EP 2322163A1
· 2011
[cited by applicant]
EP 2377860A1
· 2011
[cited by applicant]
EP 2391618A2
· 2011
[cited by applicant]
EP 2890788A1
· 2015
[cited by applicant]
EP 2911664B1
· 2019
[cited by applicant]
GB 1144906A
· 1969
[cited by applicant]
GB 1257162A
· 1971
[cited by applicant]
JP S56043448B1
· 1981
[cited by applicant]
JP H04505006A
· 1992
[cited by applicant]
JP 2000503866A
· 2000
[cited by applicant]
JP 2001151673A
· 2001
[cited by applicant]
JP 2001517691A
· 2001
[cited by applicant]
JP 2002524107A
· 2002
[cited by applicant]
JP 2003525842A
· 2003
[cited by applicant]
JP 2005510535A
· 2005
[cited by applicant]
JP 2005232171A
· 2005
[cited by applicant]
JP 2005532091A
· 2005
[cited by applicant]
JP 2007534693A
· 2007
[cited by applicant]
JP 2009536918A
· 2009
[cited by applicant]
JP 2010510254A
· 2010
[cited by applicant]
JP 2012515712A
· 2012
[cited by applicant]
JP 2012516356A
· 2012
[cited by applicant]
WO WO1987001115A1
· 1987
[cited by applicant]
WO WO9009789A2
· 1990
[cited by applicant]
WO WO1997026934A2
· 1997
[cited by applicant]
WO WO9834596A2
· 1998
[cited by applicant]
WO WO1999016422A1
· 1999
[cited by applicant]
WO WO1999064095A2
· 1999
[cited by applicant]
WO WO0228820A1
· 2002
[cited by applicant]
WO WO03045331A2
· 2003
[cited by applicant]
WO WO2004071532A1
· 2004
[cited by applicant]
WO WO2005063732A1
· 2005
[cited by applicant]
WO WO2005104712A2
· 2005
[cited by applicant]
WO WO2006056492A1
· 2006
[cited by applicant]
WO WO2007094718A1
· 2007
[cited by applicant]
WO WO2007102059A1
· 2007
[cited by applicant]
WO WO2008013799A2
· 2008
[cited by applicant]
WO WO2008061373A1
· 2008
[cited by applicant]
WO WO2008128981A1
· 2008
[cited by applicant]
WO WO2008131298A2
· 2008
[cited by applicant]
WO WO2009010770A2
· 2009
[cited by applicant]
WO WO2009133128A1
· 2009
[cited by applicant]
WO WO2010084767A1
· 2010
[cited by applicant]
WO WO2010088455A2
· 2010
[cited by applicant]
WO WO2011136754A1
· 2011
[cited by applicant]
WO WO2013148366A1
· 2013
[cited by applicant]
WO WO2014066318A1
· 2014
[cited by applicant]
WO WO2015002703A1
· 2015
[cited by applicant]
WO WO2015061397A1
· 2015
[cited by applicant]
WO WO2016081466A1
· 2016
[cited by applicant]
WO WO2016196401A1
· 2016
[cited by applicant]
WO WO2017027387A1
· 2017
[cited by applicant]
WO WO2017027402A1
· 2017
[cited by applicant]
WO WO2017072335A1
· 2017
[cited by applicant]
WO WO2017087962A1
· 2017
[cited by applicant]
WO WO2017091644A1
· 2017
[cited by applicant]
WO WO2017162884A1
· 2017
[cited by applicant]
WO WO2018045217A1
· 2018
[cited by applicant]
WO WO2018048989A1
· 2018
[cited by applicant]
WO WO2019199776A1
· 2019
[cited by applicant]
WO WO2020010049A1
· 2020
[cited by applicant]
WO WO2020051322A1
· 2020
[cited by applicant]
WO WO2020123449A1
· 2020
[cited by applicant]
WO WO2021207060A1
· 2021
[cited by applicant]
WO WO2021248022A1
· 2021
[cited by applicant]
WO WO2022146914A1
· 2022
[cited by applicant]
Anonymous: “Facts about variant Creutzfeldt-Jakob disease”, European Centre for Disease Prevention and Control, Jun. 26, 2017 (Jun. 26, 2017), pp. 1-10, XP093093988, European Centre for Disease Prevention and Control we…
[cited by applicant]
Brazier et al., “Pharmacokinetics of cromolyn and ibuprofen in healthy elderly volunteers”, Clinical drug investigation 37: 1025-1034 (2017).
[cited by applicant]
Hofman et al., “Atherosclerosis, apolipoprotein E, and prevalence of dementia and Alzheimer's disease in the Rotterdam Study,” Lancet 349: pp. 151-154 (1997).
[cited by applicant]
Manuelidis et al., “Transmissible encephalopathy agents,” Virulence 1.2 (2010): 101-104.
[cited by applicant]
Prins et al., “Treating Alzheimer's disease with monoclonal antibodies: current status and outlook for the future”, Alzheimer's research & therapy 5.6: 1-6 (2013).
[cited by applicant]
Tsivgoulis et al., “Recent Advances in Primary and Secondary Prevention of Atherosclerotic Stroke,” Journal of Stroke, 20.2 (2018): 145-166.
[cited by applicant]
Yoshimi et al., “Importance of Hydrolysis of Amino Acid Moiety in Water-Soluble Prodrugs of Disodium Cromoglycate for Increased Oral Bioavailability,” Journal of Pharmacobio-Dynamics 15.7 (1992): 339-345.
[cited by applicant]
Abraham et al., “Mast cell-orchestrated immunity to pathogens,” Nat Rev Immunol, 10: 440-452 (2010).
[cited by applicant]
Aisen et al., “Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial,” JAMA, 289(21):2819-2826 (2003).
[cited by applicant]
Akiyama et al., “Inflammation and Alzheimer's Disease,” Neurobiol Aging, 21(3):383-421 (2000).
[cited by applicant]
Alafuzoff et al., “Lower counts of astroglia and activated microglia in patients with Alzheimer's disease with regular use of non-steroidal anti-inflammatory drugs,” J Alzheimers Dis, 2(1):37-46 (2000).
[cited by applicant]
Albert et al., “Effects of age on the clinical pharmacokinetics of ibuprofen,” Am J Med, 77(1, Part 1):47-50 (1984).
[cited by applicant]
Albert et al., “Pharmacokinetics of ibuprofen,” Am J Med, 77(1A):40-46 (1984).
[cited by applicant]
Aloisi F. “Immune function of microglia”.
[cited by applicant]
Andreasen et al. “Sensitivity, specificity, and stability of CSF-tau in AD in a community-based patient sample,” Neurology. (1999) 53: 1488-94 (19 pages).
[cited by applicant]
Arnáiz et al., “Neuropsychological features of mild cognitive impairment and preclinical Alzheimer's disease,” Acta Neurol Scand Suppl. (2003) 179: 34-41.
[cited by applicant]
Aswania et al., “Relative bioavailability of sodium cromoglycate to the lung following inhalation, using urinary excretion,” J Clin Pharmacol, 47:613-618 (1999).
[cited by applicant]
Baig et al., “Use of Peptides for the Management of Alzheimer's Disease: Diagnosis and Inhibition,” Frontiers in Aging Neuroscience, 10: 1-6 (2018).
[cited by applicant]
Banati, R. B. et al., “Cytotoxicity of microglia”.
[cited by applicant]
Bannwarth et al., “Stereoselective disposition of ibuprofen enantiomers in human cerebrospinal fluid.,” Br J Clin Pharmacol, 40(3):266-269 (1995).
[cited by applicant]
Barone, F.C. et al., “Tumor necrosis factor-α: a mediator of focal ischemic brain injury”. Stroke (1997) 28, 1233-1244.
[cited by applicant]
Basek et al., “Efficacy of an Isotonic Small Droplet Size Nebulized DSCG on Asthma Control in Children,” Acta Paediatrica, 99(Suppl 462):115 (2010).
[cited by applicant]
Beach et al., “Cromolyn sodium toxicity studies in primates,” Toxicol Appl Pharmacol, 57(3):367-400 (1981).
[cited by applicant]
Beigel JH, et al. “Remdesivir for the treatment of Covid-19—preliminary report,” The New England Journal of Medicine: 1-12 (2020).
[cited by applicant]
Berge et al., “Pharmaceutical salts,” J Pharm Sci, 66(1):1-19 (1977).
[cited by applicant]
Blennow K., “Biomarkers in Alzheimer's disease drug development,” Nat Med. (2010) 16: 1218-22.
[cited by applicant]
Bodor et al., “Improved delivery through biological membranes VII. Dermal delivery of cromoglycic acid (cromolyn) via its prodrugs,” International Journal of Pharmaceutics, 7(1):63- .75 (1980).
[cited by applicant]
Bona, E. et al., “Chemokine and inflammatory cell response to hypoxia-ischemia in immature rats”.
[cited by applicant]
Bot et al., “Perivascular mast cells promote atherogenesis and induce plaque destabilization in apolipoprotein E-deficient mice,” Circulation, 115(19):2516-2525 (2007).
[cited by applicant]
Breitner et al., “Extended results of the Alzheimer's disease anti-inflammatory prevention trial,” Alzheimers Dement, 7(4):402-411 (2011).
[cited by applicant]
Breitner, “Alzheimer disease: The changing view,” Annals Neurol, 49(3):418-419 (2001).
[cited by applicant]
Broe et al., “Anti-inflammatory drugs protect against Alzheimer disease at low doses,” Arch Neurol, 57:1586-1591 (2000).
[cited by applicant]
Buchhave et al., “Cerebrospinal fluid levels of β-amyloid 1-42, but not of tau, are fully changed already 5 to 10 years before the onset of Alzheimer dementia,” Arch Gen Psychiatry. (2012) 69: 98-106.
[cited by applicant]
Bulic et al., “Tau protein and tau aggregation inhibitors,” Neuropharmacology, 59: 276-289 (2010).
[cited by applicant]
Butovsky et al., “Identification of a unique TGF-β-dependent molecular and functional signature in microglia,” Nat Neurosci, 17(3): 131-143 (2014).
[cited by applicant]
Byron et al., “Selection and Validation of Cascade Impactor Test Methods,” Respiratory Drug Delivery IX, 1: 169-178 (2004).
[cited by applicant]
Bäckman et al., “Multiple Cognitive Deficits During the Transition to Alzheimer's Disease,” Journal of Internal Medicine, (2004) 256(3): 195-204.
[cited by applicant]
Cacabelos, “Donepezil in Alzheimer's disease: From conventional trials to pharmacogenetics,” Neuropsychiatric Disease and Treatment 3(3):303-333 (2007).
[cited by applicant]
Cairns et al., “Synthesis and Structure-Activity Relationships of Disodium Cromoglycate and Some Related Compounds,” Journal of Medicinal Chemistry, 15(6):583-589 (1972).
[cited by applicant]
Carlesimo et al., “Memory Deficits in Alzheimer's Patients: A Comprehensive Review,” Neuropsychol Rev. (1992) 3(2): 119-169.
[cited by applicant]
Certificate of Analysis for Lactohale LH 201, Alpha-Lactose Monohydrate EP and USP, Full Release (DFE Pharma); Jan. 18, 2016.
[cited by applicant]
Chen et al., “Current experimental therapy for Alzheimer's Disease,” Curr Neuropharmacol, 5(2): 127-134 (2007).
[cited by applicant]
Cherry et al., “Neuroinflammation and M2 microglia: the good, the bad, and the inflamed,” J Neuroinflammation, 11(98): 1-15 (2014).
[cited by applicant]
Choi et al., “A three-dimensional human neural cell culture model of Alzheimer's disease,” Nature, 515: 274-278 (2014).
[cited by applicant]
Chow et al., “Investigation of Electrostatic Behavior of a Lactose Carrier for Dry Powder Inhalers,” Pharmaceutical Research, 25(12): 2822-2834 (2008).
[cited by applicant]
ClinicalTrials.gov. Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers. Sponsor: AZTherapies, Inc. Identifier: NCT02482324. Retrieved Apr. 9, 2020 from: http://clinicaltrials.gov/ct/show/NCT02482…
[cited by applicant]
ClinicalTrials.gov. Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI). Sponsor: AZTherapies, Inc. Identifier: NCT03202147. Retrieved Feb. 6, 2020, 2…
[cited by applicant]
ClinicalTrials.gov. Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (COGNITE). Sponsor: AZTherapies, Inc. Identifier: NCT02547818. Retrieved Apr. 9, 2020 from: https://clinic…
[cited by applicant]
ClinicalTrials.gov. Treatment of Acute Stroke With Cromolyn(Single Dose). Sponsor: Wolfson Medical Center. Identifier: NCT01175525. Retrieved Feb. 6, 2020 from: https://clinicaltrials.gov/ct2/show/NCT01175525.
[cited by applicant]
Cole et al., “Mechanisms of action of non-steroidal anti-inflammatory drugs for the prevention of Alzheimer's disease,” CNS Neurol Disord Drug Targets, 9(2):140-148 (2010).
[cited by applicant]
Conti et al., “Induction of pro-inflammatory cytokines (IL-1 and IL-6) and lung inflammation by Coronavirus-19 (COVI-19 or SARS-CoV-2): anti-inflammatory strategies,” J Biol Regul Homeost Agents, 34(2): 327-331 (2020).
[cited by applicant]
Cowell, R.M et al., “Hypoxic-ischemic injury induces macrophage inflammatory protein-1 alpha expression in immature rat brain,”
[cited by applicant]
Cox et al., “Disodium Cromoglycate (FPL 670) (‘Intal’*): A Specific Inhibitor of Reaginic Antibody-Antigen Mechanisms,” Nature, 216: 1328-1329 (1967).
[cited by applicant]
Cruz M.P., “Edaravone (Radicava): A novel neuroprotective agent for the treatment of amyotrophic lateral sclerosis,” P&T. (2018) 43(1):25-28.
[cited by applicant]
Cummings, “Alzheimer's Disease,” N Engl J Med, 351(1):56-67 (2004).
[cited by applicant]
Das et al., “Importance of particle size and shape on the tensile strength distribution and de-agglomeration of cohesive powders,” Powder Technology, 249: 297-303 (2013).
[cited by applicant]
Davies, “Clinical pharmacokinetics of ibuprofen. The first 30 years,” Clin Pharmacokinet, 34(2):101-154 (1998).
[cited by applicant]
Deiana et al., “Methylthioninium Chloride Versus Rivastigmine and Their Co-Administration Efficacy in Reversing Scopolamine-Induced Cognitive Deficits in a Pharmacological Mouse Model of Alzheimer's Disease,” Alzheimer'…
[cited by applicant]
Dello Russo et al., “The human microglial HMC3 cell line: where do we stand? A systematic literature review,” J Neuroinflammation, 15: 259 (24 pages) (2018).
[cited by applicant]
Denes, A. et al., “Proliferating resident microglia after focal cerebral ischaemia in mice,”
[cited by applicant]
Desmond, D.W. et al., “Frequency and clinical determinants of dementia after ischemic stroke.”
[cited by applicant]
Dickson et al., “Diffuse Lewy body disease,” Acta Neuropathol (Berl), 75: 8-15 (1987).
[cited by applicant]
Doody et al., “Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial,” Neurology, 72(18):1555-1581 (2009).
[cited by applicant]
Du et al., “Role of Microglia in Neurological Disorders and Their Potentials as a Therapeutic Target,” Mol Neurobiol, 54: 7567-7584 (2017).
[cited by applicant]
Dubbelaar et al., “The Kaleidoscope of Microglial Phenotypes,” Front Immunol, 9: 1753 (2018).
[cited by applicant]
Dunbar et al., “Dispersion and Characterization of Pharmaceutical Dry Powder Aerosols,” Kona, 16:7-45 (1998).
[cited by applicant]
Elmaleh, D. et al., “Evaluation of F-18 Radiolabeled Cromolyn as a Potential Aβ Polymerization Inhibitor and PET Tracer”. Poster at
[cited by applicant]
EPAR (European Public Assessment Report) Seebri Breezhaler: Retrieved online at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002430/human_med_001580.jsp&mid=WC0b01ac058001d124>: 6 pages (…
[cited by applicant]
Etminan et al., “Effect of non-steroidal anti-inflammatory drugs on risk of Alzheimer's disease: systematic review and meta-analysis of observational studies,” Brit Med J, 327:128-131 (2003).
[cited by applicant]
European Search Report for EP Application No. 13848340 dated Feb. 11, 2016.
[cited by applicant]
European Search Report for European Application No. 14819448.3 dated Feb. 2, 2017.
[cited by applicant]
Extended European Search Report for EP Application No. 10736439.0 issued Jun. 12, 2012.
[cited by applicant]
Extended European Search Report for EP Application No. 16867341.6 mailed Jun. 13, 2019.
[cited by applicant]
Extended European Search Report for EP Application No. 17934303 mailed Aug. 13, 2021.
[cited by applicant]
Extended European Search Report for EP Application No. 19786110.7 dated Mar. 7, 2022.
[cited by applicant]
Extended European Search Report for EP Application No. 19830061.8 dated Mar. 11, 2022.
[cited by applicant]
Extended European Search Report for EP Application No. 19857627.4 dated Aug. 8, 2022.
[cited by applicant]
Extended European Search Report for EP Application No. 19895399.4 dated Oct. 27, 2022.
[cited by applicant]
Extended European Search Report for EP Application No. EP 16869210 dated Sep. 19, 2019.
[cited by applicant]
Extended European Search Report for EP Application No. EP 17847576 dated Jun. 30, 2020.
[cited by applicant]
Extended European Search Report for EP Application No. EP 17918310 mailed Mar. 12, 2021.
[cited by applicant]
Extended European Search Report for EP Application No. EP 19166810 dated Sep. 23, 2019.
[cited by applicant]
Extended European Search Report for EP Application No. EP 19172666 dated Jan. 10, 2020.
[cited by applicant]
Extended European Search Report, EP 14855211.0, dated May 29, 2017.
[cited by applicant]
Fiala, M. et al., “IL-17A is increased in the serum and in spinal cord CD8 and mast cells of ALS patients,”
[cited by applicant]
Findeis et al., “Design and testing of inhibitors of fibril formation,” Methods Enzymol, 309:476-488 (1999).
[cited by applicant]
Findeis et al., “Modified-peptide inhibitors of amyloid B-peptide polymerization,” Biochemistry, 38(21):6791-6800 (1999).
[cited by applicant]
Francesch et al., “Chronic inflammation (inflammaging) and its potential contribution to age-associated diseases,” J Gerontol A Biol Sci Med Sci, 69(S1): S4-9 (2014).
[cited by applicant]
Franzius, D., et al., “Non-specific effects of calcium entry antagonists in mast cells,”
[cited by applicant]
Gadani et al., “IL-4 in the brain: a cytokine to remember,” J Immunol, 189(9): 4213-4219 (2012).
[cited by applicant]
Galimberti et al., “Disease-modifying treatments for Alzheimer's disease,” Ther Adv Neurol Disord, 4(4): 203-216 (2011).
[cited by applicant]
Garmise, “Novel Dry Powder Preparations of Whole Inactivated Influenza Virus for Nasal Vaccination,” Dissertation, University of North Carolina at Chapel Hill (2007).
[cited by applicant]
Garringer et al., “Modeling familial British and Danish dementia”, Brain Struct Funct 214(2-3): 235-244 (2010).
[cited by applicant]
Gasparini et al., “Non-steroidal anti-inflammatory drugs (NSAIDs) in Alzheimer's disease: old and new mechanisms of action,” J Neurochem, 91(3):521-536 (2004).
[cited by applicant]
Ghasemi. M. and Brown. R.H. Jr. “Genetics of amyotrophic lateral sclerosis,”
[cited by applicant]
Gilani et al., “Influence of Formulation Variables and Inhalation Device On the Deposition Profiles of Cromolyn Sodium Dry Powder Aerosols,” Daru 12(3):123-130 (2004).
[cited by applicant]
Gilead Announces Approval of Veklury (remdesivir) in Japan for Patients With Severe COVID-19. The press release of Gilead Sciences. May 7, 2020. URL: < https://www.gilead.com/news-and-press/press-room/press-releases/202…
[cited by applicant]
Gomperts et al., “Imaging amyloid deposition in Lewy body disease,” Neurology, 71(12): 903-910 (2008).
[cited by applicant]
Gorelick, P. et al., “Vascular Contributions to Cognitive Impairment and Dementia, A Statement for Healthcare Professionals from the American Heart Association/American Stroke Association,”
[cited by applicant]
Gosselin et al., “An environment-dependent transcriptional network specifies human microglia identity,” Science, 356: eaal3222 (2017).
[cited by applicant]
Granucci et al., “Cromolyn sodium delays disease onset and is neuroprotective in the SOD1G93A Mouse Model of amyotrophic lateral sclerosis,” Sci Rep, 9: 17728 (17 pages) (2019).
[cited by applicant]
Granucci et al., “Inducible IL-2 production by dendritic cells revealed by global gene expression analysis,” Nat Immunol, 2(9): 882-888 (2001).
[cited by applicant]
Greenhalgh et al., “Immune cell regulation of glia during CNS injury and disease,” Nat Rev Neurosci, 21: 139-152 (2020).
[cited by applicant]
Grenier et al., “Three-dimensional modeling of human neurodegeneration: brain organoids coming of age,” Mol Psychiatry, 25: 254-274 (2020).
[cited by applicant]
Griffin, “What causes Alzheimer's?” The Scientist, 25:36-40 (2011).
[cited by applicant]
Grundman et al., “Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials,” Arch. Neurol. (2004) 61(1): 59-66.
[cited by applicant]
Guchardi et al., “Influence of fine lactose and magnesium stearate on low dose dry powder inhaler formulations,” International Journal of Pharmaceutics 348:10-17 (2008).
[cited by applicant]
Gudesblatt et al., “Hexosaminidase A activity and amyotrophic lateral sclerosis,” Muscle and Nerve, II: 227-230 (1988).
[cited by applicant]
Guo et al., “Comparison of Delivery Characteristics from a Combination Metered-Dose Inhaler Using the Andersen Cascade Impactor and the Next Generation Pharmaceutical Impactor,” J Pharm Sci, 97(8): 3321-3334 (2008).
[cited by applicant]
Guo, J. et al., “Evaluating the levels of CSF and serum factors in ALS,”
[cited by applicant]
Gwin et al., “Cromolyn sodium in the treatment of asthma associated with aspirin hypersensitivity and nasal polyps,” Chest, 72(2):148-153 (1977).
[cited by applicant]
Haass et al., “Soluble protein oligomers in neurodegeneration: lessons from the Alzheimer's amyloid [beta]-peptide,” Nat Rev Mol Cell Biol, 8(2):101-112 (2007).
[cited by applicant]
Hallenbeck, J.M. “The many faces of tumor necrosis factor in stroke”. Nat Med (2002) 8, 1363-1368.
[cited by applicant]
Han et al., “The therapeutic effects of sodium cromoglycate against influenza A virus H5N1 in mice,” Influenza and Other Respiratory Viruses, 10(1): 57-66 (2015).
[cited by applicant]
Hashimoto et al., “Apolipoprotein E, especially apolipoprotein E4, increases the oligomerization of amyloid β peptide,” J Neurosci, 32(43):15181-15192 (2012).
[cited by applicant]
He et al., “Progress of Inhaled Devices for Asthma,” Journal of Applied Clinical Pediatrics, 22(4):309-311 (2007).
[cited by applicant]
Hemonnot et al., “Microglia in Alzheimer Disease: Well-Known Targets and New Opportunities,” Front Aging Neurosci, 11:233(20 pages) (2019).
[cited by applicant]
Heneka et al., “Acute treatment with the PPARγ agonist pioglitazone and ibuprofen reduces glial inflammation and Aβ1-42 levels in APPV7171 transgenic mice,” Brain, 128:1442-1453 (2005).
[cited by applicant]
Hensley, “Neuroinflammation in Alzheimer's Disease: Mechanisms, Pathologic Consequences, and Potential for Therapeutic Manipulation,” J Alzheimers Dis, 21(1):1-14 (2010).
[cited by applicant]
Hirouchi, “Current status and perspectives on the development of therapeutic agents for Alzheimer's disease,” Nihon Yakurigaku Zasshi, 123(6):421-427 (2004).
[cited by applicant]
Holian et al., “Mechanistic aspects of cromolyn sodium action on the alveolar macrophage: inhibition of stimulation by soluble agonists,” Agents Actions, 33: 318-325 (1991).
[cited by applicant]
Hoozemans et al., “Soothing the inflamed brain: effect of non-steroidal anti-inflammatory drugs on Alzheimer's disease pathology,” CNS Neurol Disord Drug Targets, 10(1):57-67 (2011).
[cited by applicant]
Hopperton et al., “Markers of microglia in post-mortem brain samples from patients with Alzheimer's disease: a systematic review,” Mol Psychiatry, 23: 177-198 (2018).
[cited by applicant]
Hori et al., “A Food and Drug Administration-approved asthma therapeutic agent impacts amyloid beta in the brain in a transgenic model of Alzheimer disease,” J Biol Chem, 290(4): 1966-1978 (2015).
[cited by applicant]
Hu et al., “Increased peripheral blood inflammatory cytokine levels in amyotrophic lateral sclerosis: a meta-analysis study,” Scientific Reports, 7: Article No. 9094 (2017).
[cited by applicant]
Huang et al., “Acute stress induces cardiac mast cell activation and histamine release, effects that are increased in Apolipoprotein E knockout mice.,” Cardiovasc Res, 55(1):150-160 (2002).
[cited by applicant]
Huang et al., “Stress-induced interleukin-6 release in mice is mast cell-dependent and more pronounced in Apolipoprotein E knockout mice,” Cardiovasc Res, 59(1):241-249 (2003).
[cited by applicant]
Ihle-Hansen, H. et al., “Incidence and subtypes of MCI and dementia 1 year after first-ever stroke in patients without pre-existing cognitive impairment,”
[cited by applicant]
Ilieva, H., et al., “Non-cell autonomous toxicity in neurodegenerative disorders: ALS and beyond,”
[cited by applicant]
Imbimbo et al., “Are NSAIDs useful to treat Alzheimer's disease or mild cognitive impairment?,” Front Aging Neurosci, 2(19):1-14 (2010).
[cited by applicant]
Imbimbo, “An update on the efficacy of non-steroidal anti-inflammatory drugs in Alzheimer's disease,” Expert Opinion on Investigational Drugs, 2009; 18(8), pp. 1147-1168.
[cited by applicant]
InnoPharmalabs, “Particle Size Distribution”, Apr. 9, 2013 (Apr. 9, 2013).
[cited by applicant]
Intal Approval Package, Center for Drug Evaluation and Research, application 75-175, pp. 1-5 (Dec. 12, 1997).
[cited by applicant]
Intal® Nebulizer Solution (Label 2016): Retrieved online at <http://labeling.pfizer.com/ShowLabeling.aspx?id=833>: 4 pages (2016).
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US2019/040247 dated Jan. 14, 2021.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US16/63143 mailed Feb. 6, 2017.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US16/63462 mailed Feb. 1, 2017.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US17/65727 mailed Feb. 12, 2018.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US19/49733 dated Jan. 13, 2020.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2010/022495 dated Nov. 10, 2010.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2014/061694 dated Jan. 2, 2015.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2017/049702 dated Dec. 26, 2017.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2019/026521 dated Jun. 14, 2019.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2019/040247 dated Sep. 20, 2019.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2021/025746 mailed Jun. 17, 2021.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2021/035936 dated Jul. 22, 2021.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2021/065200 dated Mar. 24, 2022.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US19/65384 dated Mar. 31, 2020.
[cited by applicant]
International Search Report for International Application No. PCT/US2013/066069 mailed Mar. 13, 2014.
[cited by applicant]
International Search Report for International Application No. PCT/US14/39118 dated Sep. 18, 2014.
[cited by applicant]
Jellinger, K.A., “Alzheimer disease and cerebrovascular pathology: an update”.
[cited by applicant]
Jin et al., “Mast cells are early responders after hypoxia-ischemia in immature rat brain,” Stroke, 40(9):3107-3112 (2009).
[cited by applicant]
Jin, R. et al., “Inflammatory mechanisms in ischemic stroke: role of inflammatory cells,”
[cited by applicant]
Jin, Y. et al., “Mast cell stabilization limits hypoxic-ischemic brain damage in the immature rat”.
[cited by applicant]
Jurga et al., “Overview of General and Discriminating Markers of Differential Microglia Phenotypes,” Front Cell Neurosci, 14: 198 (18 pages) (2020).
[cited by applicant]
Kamiya., “Characteristics and problems of cascade impactors in the evaluation of inhaled preparations,” Journal of Pharmaceutical Science and Technology, Japan, 65(4): English Machine Translation (5 pages)(2005).
[cited by applicant]
Karadsheh, “Rapid response to: Covid-19: what treatments are being investigated?” BMJ (4 pages) (2020).
[cited by applicant]
Karran et al., “The amyloid cascade hypothesis for Alzheimer's disease: an appraisal for the development of therapeutics,” Nat Rev, 10(9):698-712 (2011).
[cited by applicant]
Kaur et al., “Drug Therapy in Stroke: From Preclinical to Clinical Studies,” Pharmacology, 92:324-334 (2013).
[cited by applicant]
Kay et al., “Disodium cromoglycate inhibits activation of human inflammatory cells in vitro,” J Allergy Clin Immunol, 80(1): 1-8 (1987).
[cited by applicant]
Keizman D. et al. Low-grade systemic inflammation in patients with amyotrophic lateral sclerosis.
[cited by applicant]
Keller et al., “Have inadequate delivery systems hampered the clinical success of inhaled disodium cromoglycate? Time for reconsideration,” Exp Opin Drug Deliv, 8(1):1-17 (2011).
[cited by applicant]
Kelley et al., “The molecular role of mast cells in atherosclerotic cardiovascular disease,” Mol Med Today, 6:304-308 (2000).
[cited by applicant]
Kilpatrick et al., “Cromolyn inhibits assembly of the NADPH oxidase and superoxide anion generation by human neutrophils,”
[cited by applicant]
Knowles, “Donepezil in Alzheimer's disease: an evidence-based review of its impact on clinical and economic outcomes,” Core Evid, 1(3):195-219 (2006).
[cited by applicant]
Kohman et al., “Neurogenesis, inflammation and behavior,” Brain Behav Immun, 27C:22-32 (2013).
[cited by applicant]
Kondo et al., “iPSC-Based Compound Screening and In Vitro Trials Identify a Synergistic Anti-amyloid β Combination for Alzheimer's Disease,” Cell Rep, 21: 2304-2312 (2017).
[cited by applicant]
Koo et al., “Amyloid diseases: Abnormal protein aggregation in neurodegeneration, ” PNAS, 96:9989-9990 (1999).
[cited by applicant]
Kotilinek et al., “Cyclooxygenase-2 inhibition improves amyloid-β-mediated suppression of memory and synaptic plasticity,” Brain, 131(3):651-664 (2008).
[cited by applicant]
Koudstaal et al., “Secondary Stroke Prevention in Atrial Fibrillation: Indications, Risks, and Benefits,” J Thromb Thrombolys, 7(1):61-65 (1999).
[cited by applicant]
Krstic et al., “Deciphering the mechanism underlying late-onset Alzheimer disease,” Nat Rev Neurol, 9:25-34(2013).
[cited by applicant]
Krueger, M. et al., “Blood-brain barrier breakdown involves four distinct stages of vascular damage in various models of experimental focal cerebral ischemia,”
[cited by applicant]
Kuhle, J. et al., Increased levels of inflammatory chemokines in amyotrophic lateral sclerosis,
[cited by applicant]
Kumon et al., “Application and Mechanism of Inhalation Profile Improvement of DPI Formulations by Mechanofusion with Magnesium Stearate,” Chemical and Pharmaceutical Bulletin, 56(5): 617-625 (2008).
[cited by applicant]
Kwong et al., “Comparison of Nebulized Particle Size Distribution with Malvern Laser Diffraction Analyzer Versus Andersen Cascade Impactor and Low-Flow Marple Personal Cascade Impactor,” J Aerosol Med, 13(4): 303-314 (2…
[cited by applicant]
Lalancette-Hébert, M. et al., “Selective ablation of proliferating microglial cells exacerbates ischemic injury in the brain,”
[cited by applicant]
Lanari, et al., “Cerebrospinal fluid biomarkers and prediction of conversion in patients with mild cognitive impairment: 4-year follow-up in a routine clinical setting,” Scientific World Journal. (2009) 9: 961-6.
[cited by applicant]
Lanz et al., “The y-Secretase Inhibitor N-[N-(3,5-Difluorophenacetyl)-L-alanyl]-S-phenylglycine t-butyl Ester Reduces Aβ Levels in Vivo in Plasma and Cerebrospinal Fluid in Young (Plaque-Free) and Aged (Plaque-Bearing) …
[cited by applicant]
Lasiene, J and Yamanaka, K., “Glial cells in amyotrophic lateral sclerosis,”
[cited by applicant]
Lee, P.H. et al., “Circulating beta amyloid protein is elevated in patients with acute ischemic stroke”.
[cited by applicant]
Lehman, L.L. and Rivkin, M.J., “Perinatal arterial ischemic stroke: Presentation, risk factors, evaluation, and outcome”.
[cited by applicant]
Lewis et al., “Quantification of Alzheimer pathology in aging and dementia: age-related accumulation of amyloid-β (42) peptide in vascular dementia,” Neuropathology and Applied Neurobiology, 32(2): 103-118 (2006).
[cited by applicant]
Li et al., “TREM2 regulates innate immunity in Alzheimer's disease,” J Neuroinflammation, 15: 107 (7 pages) (2018).
[cited by applicant]
Libby, “Inflammation in atherosclerosis,” Nature, 420(6917):868-874 (2002).
[cited by applicant]
Lim et al., “Ibuprofen Suppresses Plaque Pathology and Inflammation in a Mouse Model of Alzheimer's Disease,” The Journal of Neuroscience 20(15):5709-5714 (2000).
[cited by applicant]