当前位置： SCI文献检索 > CLINICAL THERAPEUTICS期刊下所有文献 > Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Regulatory Initiatives in Japan and the United States.

Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Regulatory Initiatives in Japan and the United States.

Abstract：

PURPOSE:The incidence of Alzheimer's disease (AD) has been steadily increasing worldwide. AD is a serious disease that has both societal and economic impacts. The greatest risk factor for AD is aging. Thus, because of the rapidly aging population in Japan, the development of new, effective drugs for AD is urgently needed. The goal of the present article was to analyze the status, clarify the problems, and discuss the scientific and political challenges of disease-modifying drug development for AD. METHODS:Public data, official documents, literature, and news releases were surveyed and discussed. FINDINGS:Compared with diabetes mellitus drugs, there is a lack of quantitative surrogate end points among AD drugs. Much AD drug development has focused on amyloid-β and its associated pathways; however, these drugs have not shown efficacy in Phase III clinical trials. Thus, the US Food and Drug Administration has appealed for a new draft industrial guidance for the development of AD drugs, including those for early-stage AD. In Japan, the Minister of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency have also taken action, including the publication of potential new guidelines for clinical evaluation and development of new AD therapeutics, including drugs. Moreover, scientific initiatives to develop novel AD drugs are ongoing. IMPLICATIONS:The development of quantitative surrogate end points remains necessary to improve the development of AD drugs. Therefore, collaboration among industry, government, and academia should be encouraged. Following the principles of regulatory science, strategies to develop drugs for illnesses with unmet needs can be framed by investigating the effects of past, current, and future AD drug development initiatives.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Tsukamoto K

doi

10.1016/j.clinthera.2015.02.024

subject

Has Abstract

pub_date

2015-08-01 00:00:00

pages

1652-60

issue

8

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(15)00095-8

journal_volume

37

pub_type

杂志文章

相关文献

CLINICAL THERAPEUTICS文献大全
  • Efficacy of long-term treatment with nipradilol, a nitroester-containing beta-blocker, in patients with mild-to-moderate essential hypertension.

    abstract：:The effects of long-term treatment with nipradilol, a nitroester-containing beta-blocker, on casual and 24-hour blood pressures were studied in 70 patients with mild-to-moderate essential hypertension. Antihypertensive effects of nipradilol on casual blood pressure were observed in 68% of patients. Nipradilol reduced ...

    journal_title：Clinical therapeutics

    pub_type： 临床试验,杂志文章

    doi：10.1016/0149-2918(95)80043-3

    authors： Haneda T,Ogawa Y,Akaishi T,Takeda H,Tanazawa S,Inoue H,Ohki Y,Kato J,Morimoto H,Kanaya K

    更新日期：1995-07-01 00:00:00

  • Retrospective review of sex differences in the management of dyslipidemia in coronary heart disease: an analysis of patient data from a Maryland-based health maintenance organization.

    abstract：BACKGROUND:Coronary heart disease (CHD) is the leading cause of death in men and women in the United States, with a higher mortality in women, despite a lower prevalence. Statins effectively treat dyslipidemia and reduce the risk of CHD mortality. OBJECTIVE:The objective of this study was to evaluate the treatment of ...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2006.04.012

    authors： Cooke CE,Hammerash WJ Jr

    更新日期：2006-04-01 00:00:00

  • Single-pill Combination Therapy of Azilsartan Medoxomil/Chlorthalidone for Treatment of Hypertension: A Systematic Review.

    abstract：PURPOSE:The goal of this study was to review recent clinical studies of azilsartan medoxomil (AZL-M) and chlorthalidone (CLD), a combined angiotensin receptor blocker and thiazide-like diuretic, and its role in recently published guidelines. This review explores the role of AZL-M/CLD in treating patients with hypertens...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/j.clinthera.2020.05.015

    authors： Kwon A,Kim GH

    更新日期：2020-07-01 00:00:00

  • Alendronate and raloxifene use related to cardiovascular diseases: differentiation by different dosing regimens of alendronate.

    abstract：BACKGROUND:Bisphosphonates are the class of medication used most widely to treat osteoporosis. Since an article reported that patients who used zoledronic acid, a bisphosphonate, had a higher proportion of atrial fibrillation (AF) in 2007, the issue of bisphosphonates and AF has become a growing concern. Due to the wid...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2011.07.012

    authors： Lu PY,Hsieh CF,Tsai YW,Huang WF

    更新日期：2011-09-01 00:00:00

  • Efficacy of brimonidine as replacement therapy in patients with open-angle glaucoma or ocular hypertension.

    abstract：BACKGROUND:Patients with glaucoma or ocular hypertension may have inadequately controlled intraocular pressure (IOP) or experience adverse effects with their current medication regimens. OBJECTIVE:This post hoc reanalysis determined the effectiveness and tolerability of brimonidine used as replacement therapy in a rea...

    journal_title：Clinical therapeutics

    pub_type： 临床试验,杂志文章,多中心研究

    doi：10.1016/s0149-2918(00)87977-1

    authors： Lee DA

    更新日期：2000-01-01 00:00:00

  • Panitumumab: human monoclonal antibody against epidermal growth factor receptors for the treatment of metastatic colorectal cancer.

    abstract：BACKGROUND:Panitumumab, formerly known as ABX-EGF, was the first recombinant human immunoglobulin G2 monoclonal antibody approved by the US Food and Drug Administration for the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer (mCRC) refractory to fluoropyrimidine-, oxa...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/j.clinthera.2008.01.014

    authors： Wu M,Rivkin A,Pham T

    更新日期：2008-01-01 00:00:00

  • Comparison of once-daily cephalosporin regimens for community-acquired lower respiratory tract infections in patients with chronic lung disease.

    abstract：:The efficacy of cefonicid and of ceftriaxone, administered once daily for the treatment of lower respiratory tract bacterial infections (pneumonia or bronchitis), was evaluated and compared in 118 patients with chronic lung disease. The patients were randomly assigned to receive 1 gm of either drug, intravenously or i...

    journal_title：Clinical therapeutics

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：

    authors： McCabe RE,Schlossberg D,Donowitz GR,Scheld WM,Zellner SR,Lindenberg LB,Armstrong JH,Ein ME

    更新日期：1989-05-01 00:00:00

  • Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review.

    abstract：BACKGROUND:Considerable clinical data on the treatment of type 2 diabetes with incretin-based therapies (glucagon-like peptide 1 receptor agonists [GLP-1RAs] and dipeptidyl-peptidase IV [DPP-4] inhibitors) are available. OBJECTIVE:This meta-analysis was performed to support the understanding of the overall evidence by...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,meta分析,评审

    doi：10.1016/j.clinthera.2012.04.013

    authors： Aroda VR,Henry RR,Han J,Huang W,DeYoung MB,Darsow T,Hoogwerf BJ

    更新日期：2012-06-01 00:00:00

  • Comparison of propofol, droperidol, and metoclopramide for prophylaxis of postoperative nausea and vomiting after breast cancer surgery: a prospective, randomized, double-blind, placebo-controlled study in Japanese patients.

    abstract：BACKGROUND:Breast cancer surgery performed with the patient under general anesthesia has been associated with a relatively high incidence of postoperative nausea and vomiting (PONV). Between 60% and 80% of patients who undergo mastectomy (with axillary dissection) experience PONV. We previously reported that propofol a...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,随机对照试验,收录出版

    doi：10.1016/j.clinthera.2008.11.011

    authors： Fujii Y,Itakura M

    更新日期：2008-11-01 00:00:00

  • Type 2 Diabetes, Hypoglycemia, and Basal Insulins: Ongoing Challenges.

    abstract：:Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/j.clinthera.2016.09.020

    authors： Blumer I,Clement M

    更新日期：2017-08-01 00:00:00

  • Microcosting Study of Rituximab Subcutaneous Injection Versus Intravenous Infusion.

    abstract：PURPOSE:The goal of this study is to identify and compare all direct costs of intravenous and subcutaneous rituximab given to patients with diffuse large B-cell lymphoma in the Netherlands. METHODS:Using a prospective, observational, bottom-up microcosting study, we collected primary data on the direct medical costs o...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2017.05.342

    authors： Mihajlović J,Bax P,van Breugel E,Blommestein HM,Hoogendoorn M,Hospes W,Postma MJ

    更新日期：2017-06-01 00:00:00

  • Limited Sampling Strategy for Accurate Prediction of Pharmacokinetics of Saroglitazar: A 3-point Linear Regression Model Development and Successful Prediction of Human Exposure.

    abstract：PURPOSE:Our aim was to develop and validate the extrapolative performance of a regression model using a limited sampling strategy for accurate estimation of the area under the plasma concentration versus time curve for saroglitazar. METHODS:Healthy subject pharmacokinetic data from a well-powered food-effect study (fa...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,随机对照试验

    doi：10.1016/j.clinthera.2018.01.016

    authors： Joshi SN,Srinivas NR,Parmar DV

    更新日期：2018-03-01 00:00:00

  • A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee.

    abstract：BACKGROUND:Oxymorphone extended release (ER) is a tablet formulation of the mu-opioid agonist oxymorphone designed to achieve a low peak-to-trough fluctuation in plasma concentrations over a 12-hour dosing period. OBJECTIVE:This study compared the analgesic efficacy, dose response, and tolerability of 3 doses of oxymo...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,多中心研究,随机对照试验

    doi：10.1016/j.clinthera.2006.03.008

    authors： Kivitz A,Ma C,Ahdieh H,Galer BS

    更新日期：2006-03-01 00:00:00

  • Midodrine for female incontinence: a preliminary report.

    abstract：:Twenty-six women (aged 26 to 60) with stress incontinence underwent urodynamic investigation before and after oral administration of 5 mg of midodrine, a new adrenergic agent with alpha-stimulant activity. A significant increase in maximum urethral closing pressure combined with a nonsignificant increase in flow time ...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：

    authors： Garofalo F,Lalanne GM,Nanni G

    更新日期：1986-01-01 00:00:00

  • Glycopyrrolate for chronic drooling in children.

    abstract：BACKGROUND:Sialorrhea, or drooling, is seen in the pediatric population, especially in patients with cerebral palsy and other neurodevelopmental disabilities. If medication use is warranted, anticholinergic agents are the drug of choice; however, adverse effects limit their use. Glycopyrrolate, a synthetic anticholiner...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/j.clinthera.2012.02.026

    authors： Eiland LS

    更新日期：2012-04-01 00:00:00

  • Management of refractory essential thrombocythemia with anagrelide in a patient undergoing hemodialysis.

    abstract：BACKGROUND:Management of essential thrombocythemia (ET) in high-risk patients is difficult because high platelet numbers can lead to vascular occlusive events and bleeding. Therapeutic interventions in ET are limited to hydroxyurea and anagrelide; however, in Europe, anagrelide is contraindicated in patients with chron...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2009.11.006

    authors： Mesquita Mdo C,Sol EB,Malarme M,Noubouossie D,Demulder AC

    更新日期：2009-11-01 00:00:00

  • Management of Spastic Paresis and Cervical Dystonia: Access to Therapeutic Innovations Through an International Program of Practical Courses.

    abstract：PURPOSE:Our purpose was to determine satisfaction and confidence of the Ixcellence Network training program on health care practitioners using botulinum toxin A (BoNT-A) for neurologic disorders, including spastic paresis and cervical dystonia. METHODS:The Ixcellence Network training program was designed by a scientif...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2019.09.007

    authors： Colosimo C,Bhidayasiri R,Fheodoroff K,Bhatia K,Chung TM,Landreau T,Jacinto LJ

    更新日期：2019-11-01 00:00:00

  • Quality of life of people with epilepsy in the United States.

    abstract：:Health care provision in the United States is driven by the fact that most health insurance is commercial and private. This leads to the tendency to view patients as units that will produce a future cash yield. The quality of life (QOL) movement in the United States is in some ways a response to this view and has a ro...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/s0149-2918(98)80021-0

    authors： Leppik IE

    更新日期：1998-01-01 00:00:00

  • Enoxacin in the treatment of typhoid fever.

    abstract：:Enoxacin 400 mg twice daily was given orally to 40 patients who had Salmonella typhi- or Salmonella paratyphi-positive blood or bone marrow cultures. One patient was switched to parenteral therapy within 48 hours of study enrollment, but the remaining 39 patients were given enoxacin for 10 to 14 days. All 39 patients ...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：

    authors： Ahmed A,Salahuddin N,Ahsan T,Afsar S,Nasir N,Farooqui S,Chaoudri AN,Akhtar MA,Agha I,Nagi N

    更新日期：1992-11-01 00:00:00

  • Recent Advances in the Pathogenesis of Mucormycoses.

    abstract：PURPOSE:The purposes of this review are to describe the pathogenesis of mucormycosis and to address recent research advances in understanding the mechanisms of fungal invasion and dissemination. METHODS:Studies and reviews published in the PubMed and ClinicalTrials.gov databases until December 2017 that explored or re...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/j.clinthera.2018.03.009

    authors： Petrikkos G,Tsioutis C

    更新日期：2018-06-01 00:00:00

  • Conscientious objection and abortifacient drugs.

    abstract：:The legal right to assert a conscientious objection is reviewed, using as an example the dispensing of abortifacient drugs by pharmacists. The three areas of law that most significantly concern the right to assert a conscientious refusal are employment law, conscience clauses, and religious discrimination law. Each of...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：

    authors： Brushwood DB

    更新日期：1993-01-01 00:00:00

  • Restored Plasma Anandamide and Endometrial Expression of Fatty Acid Amide Hydrolase in Women With Polycystic Ovary Syndrome by the Combination Use of Diane-35 and Metformin.

    abstract：PURPOSE:Polycystic ovary syndrome (PCOS) is a metabolic and endocrinal disorder affecting a number of women of reproductive age. We aimed to reveal the correlation between the endocannabinoid system and PCOS, which may provide a new therapeutic target for PCOS treatment. METHODS:Serum levels of anandamide and 2-arachi...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2017.02.007

    authors： Cui N,Feng X,Zhao Z,Zhang J,Xu Y,Wang L,Hao G

    更新日期：2017-04-01 00:00:00

  • Pharmacokinetic properties of single-dose loratadine and ambroxol alone and combined in tablet formulations in healthy men.

    abstract：BACKGROUND:Due to Mexico's complicated socioeconomic environment, causing a high occurrence of >1 person sharing a single room, respiratory conditions are spread easily. Respiratory conditions are the main reason for consultation with a physician. The most frequent symptoms are throat soreness and cough; therefore, a n...

    journal_title：Clinical therapeutics

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1016/s0149-2918(03)80215-1

    authors： Villacampa J,Alcántar F,Rodríguez JM,Morales JM,Herrera J,Rosete R

    更新日期：2003-08-01 00:00:00

  • Comparison of fixed-dose combinations of telmisartan/hydrochlorothiazide 40/12.5 mg and 80/12.5 mg and a fixed-dose combination of losartan/hydrochlorothiazide 50/12.5 mg in mild to moderate essential hypertension: pooled analysis of two multicenter, pros

    abstract：BACKGROUND:High incidences of cardiovascular events coincide with a surge in blood pressure (BP) that occurs in the early morning hours at the time of arousal. Thus, control of BP at this time of day, using oral fixed-dose combinations (FDCs) as required, is important in reducing cardiovascular risk in hypertensive pat...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,meta分析

    doi：10.1016/j.clinthera.2005.11.014

    authors： Lacourcière Y,Neutel JM,Schumacher H

    更新日期：2005-11-01 00:00:00

  • An evaluation of patients' preferences for osteoporosis medications and their attributes: the PREFER-International study.

    abstract：BACKGROUND:Patients' preferences for medications may be important in determining their compliance with therapy, particularly in the case of an asymptomatic chronic disease such as osteoporosis. Although preferences for certain attributes of osteoporosis medications, including dosing frequency and tolerability, can be e...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/s0149-2918(07)80087-7

    authors： Duarte JW,Bolge SC,Sen SS

    更新日期：2007-03-01 00:00:00

  • Single-dose, two-way crossover, bioequivalence study of Mycophenolate mofetil 500 mg tablet under fasting conditions in healthy male subjects.

    abstract：BACKGROUND:Mycophenolate mofetil (MMF) is an immunosuppressant indicated for prophylaxis of acute organ transplant rejection. Generic MMF is less costly than the branded product, but European regulatory authorities require bioequivalence studies for the marketing of generics. OBJECTIVES:The aims of the 2 studies repor...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,随机对照试验

    doi：10.1016/j.clinthera.2011.04.003

    authors： Patel S,Chauhan V,Mandal J,Shah S,Patel K,Saptarshi D,Maheshwari K,Jha PK,Kale P,Patel K,Mathew P

    更新日期：2011-03-01 00:00:00

  • Necessity of rethinking oral pediatric formulations.

    abstract：:This commentary reviews the difficulties in formulating oral products for children. The significance of the fragmentation of the pediatric population in terms of development and ability to ingest different dosage formulations is examined. It is postulated that a flexible formulation, acceptable by all patient groups, ...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/j.clinthera.2014.01.010

    authors： Bar-Shalom D

    更新日期：2014-02-01 00:00:00

  • Efficacy of budesonide in moderate to severe asthma.

    abstract：BACKGROUND:The worldwide prevalence of asthma is increasing by approximately 50% per decade. Budesonide is one of several inhaled corticosteroids available for the treatment of asthma and has been extensively evaluated in clinical trials. OBJECTIVE:This article reviews the published literature on the efficacy of budes...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章,评审

    doi：10.1016/s0149-2918(02)80005-4

    authors： O'Connell EJ

    更新日期：2002-06-01 00:00:00

  • Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs.

    abstract：PURPOSE:In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2015.11.011

    authors： Levin P,Zhou S,Durden E,Farr AM,Gill J,Wei W

    更新日期：2016-01-01 00:00:00

  • Cost-effectiveness of routine varicella vaccination using the measles, mumps, rubella and varicella vaccine in France: an economic analysis based on a dynamic transmission model for varicella and herpes zoster.

    abstract：PURPOSE:Each year in France, varicella and zoster affect large numbers of children and adults, resulting in medical visits, hospitalizations for varicella- and zoster-related complications, and societal costs. Disease prevention by varicella vaccination is feasible, wherein a plausible option involves replacing the com...

    journal_title：Clinical therapeutics

    pub_type： 杂志文章

    doi：10.1016/j.clinthera.2015.01.006

    authors： Littlewood KJ,Ouwens MJ,Sauboin C,Tehard B,Alain S,Denis F

    更新日期：2015-04-01 00:00:00