失智症防治照護政策綱領

posted Sep 1, 2013, 8:37 AM by 林昆儒   [ updated Sep 1, 2013, 8:38 AM ]

新成立的衛生福利部在上週 (2013-08-26) 公佈了「失智症防治照護政策綱領」。依據幾個月前政府委託台灣失智症協會所做的台灣首次大規模失智症盛行率調查,2012年台灣失智人口已經逼近十九萬多人,而且將隨著人口老化逐年增加。這份綱領的出爐也讓台灣在失智照護的領域向前再邁出一步!


這份文件裡頭列出七大綱領的施政重點
  1. 提高民眾對失智症防治及照護的認知
  2. 完善社區照護網絡
  3. 強化基層防治及醫療照護服務
  4. 發展人力資源強化服務知能
  5. 強化跨部門合作與資源整合
  6. 鼓勵失智症相關研究與國際合作
  7. 保障權益
其中針對第六項,將是我們團隊共同努力的目標!

CMS 同意有限度開放給付類澱粉蛋白正子掃描

posted Jul 6, 2013, 7:48 PM by 林昆儒   [ updated Jul 6, 2013, 7:50 PM ]

雖然美國 Center for Medicare & Medicaid Services 今年 2013-07-03 再次擋下針對失智症以及神經退化疾病患者全面給付 beta Amyloid positron emission tomography (類澱粉蛋白正子掃描)  


但該局同時也肯定並認為有一定證據顯示這項檢查 (類澱粉蛋白正子掃描) 在 
1) 排除阿茲海默失智症,以及 
2)  協助臨床試驗開發治療失智症藥物上的益處,
所以,該局提議每位病患可以給付一次類澱粉蛋白正子掃描,其條件如下:

Clinical study objectives must be to (1) develop better treatments or prevention strategies for AD, or, as a strategy to identify subpopulations at risk for developing AD, or (2) resolve clinically difficult differential diagnoses (e.g., frontotemporal dementia (FTD) versus AD) where the use of PET Aβ imaging appears to improve health outcomes.

Clinical studies must be approved by CMS, involve subjects from appropriate populations, be comparative, prospective and longitudinal, and use randomization and postmortem diagnosis as the endpoint where appropriate. Radiopharmaceuticals used in the PET Aβ scans must be FDA approved.  The studies must address one or more of the following questions. For Medicare beneficiaries with cognitive impairment suspicious for AD, or who may be at risk for developing AD:

  1. Do the results of PET Aβ imaging lead to improved health outcomes? Meaningful health outcomes of interest include: avoidance of futile treatment or tests; improving, or slowing the decline of, quality of life; and survival.


  2. Are there specific subpopulations, patient characteristics or differential diagnoses that are predicitive of improved health outcomes in patients whose management is guided by the PET Aβ imaging?


  3. Does using PET Aβ imaging in guiding patient management, to enrich clinical trials seeking better treatments or prevention strategies for AD, by selecting patients on the basis of biological as well as clinical and epidemiological factors, lead to improved health outcomes?

Any clinical study undertaken pursuant to this national coverage determination (NCD) must adhere to the timeframe designated in the approved clinical study protocol. Any approved clinical study must also adhere to the following standards of scientific integrity and relevance to the Medicare population.

  1. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
  2. The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
  3. The research study does not unjustifiably duplicate existing studies.
  4. The research study design is appropriate to answer the research question being asked in the study.
  5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
  6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56.
  7. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).
  8. The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements.
  9. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
  10. The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.
  11. The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early.  The results must be made public within 24 months of the end of data collection.  If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org). However a full report of the outcomes must be made public no later than three (3) years after the end of data collection.
  12. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial.  If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
  13. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention.  Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Frontier in Neurodegenerative diseases and beyond-from basic to translational

posted Jun 24, 2013, 11:25 PM by 林昆儒

中研院與長庚醫院共同舉辦的 Frontier in Neurodegenerative diseases and beyond-from basic to translational (神經退化疾病基礎與醫學新知國際研討會) (3-4, May 2013)

28th International conference of Alzheimer's disease international

posted Jun 24, 2013, 11:25 PM by 林昆儒

失智症協會舉辦的: 28th International conference of Alzheimer's disease international (18-20, Apr 2013) 

Most downloaded article

posted May 11, 2013, 1:36 AM by 林昆儒   [ updated May 11, 2013, 1:42 AM ]

過去本科也發了不少研究論文,除了改變醫療指引,評估影像力另一個指標便是下載次數了,前些日子收到了Nuclear Medicine Biology寄來的電郵,恭喜我們研究團隊一篇關於失智診斷藥物的文章,在過去一年 (2012) 成為下載次數最多的前三名!! 


更難得的是這篇文章是2010年發表的,直到2012年還是廣受學界的重視!

原始文章:

2013 長庚神經內外科論壇

posted Feb 13, 2013, 12:12 AM by 林昆儒   [ updated Feb 13, 2013, 12:18 AM ]

開春第一炮,長庚在 2013-01-13 於張榮發基金會國際會議中心舉行2013 Chang Gung Neurology & Neurosurgery Forum( CGNNSF)。

本次研討會結合台灣地區神經內外科醫師與神經科學學者,共同研討最新的臨床神經科學,藉由論壇的舉行期許能提供為國內神經科學研究的交流平台,促成院際間研究合作。其中會議第一場Keynote: The genetic architecture of Parkinson's disease 由 NIH 一位年輕的 PI Andrew Singleton主講。接著由日本的學者報告 Application of MEG for neurosurgical condition and study of neuroscience.

本次會議邀請國外的學者專家做專題演講,另舉辦9個併行會議(parallel sessions),將對下列9個重要主題進行研討: 
1. Mitochondrial Diseases and Oxidative Stress 
2. Neurogenetics 
3. Cerebrovascular Diseases
4. Neurooncology and Neuroscience 
5. Neuroimages
6. Neuromodulation Therapy for Neurological Disorders
7. Clinical Neurophysiology 
8. Neuroimmunology and Pain Syndrome
9. Neurological Infection

希望透過基礎研究和臨床應用之知識交流,與會者皆能滿載而歸。
本科我以及閻主任,還有核醫會理事長黃文盛醫師也在下午場貢獻了一個影像的section 5,
其中第一場由一位韓國的講者 Jae-Hong Lee 報告 Amyloid PET imaging in dementic disorders.

Jae-Hong 建議Amyloid PET的臨床運用可能包括: 
  1. Early-onset dementia (<65 yrs of age) - AD clinical features and MRI often atypical and FTD relatively common. Major prognostic implications.
  2. MCI - 60% of AD, 10% of other dementias, 30% not neurodegenerative
  3. Dementia with atypical or focal features - primary progressive aphasia (40% AD), corticobasal syndrome (30%AD).
  4. Complex assessment -- severe depression, stroke, etc.
  5. NOT indicated in asymptomatic persons or typical AD.
希望藉由討論能讓臨床醫師對分子影像相關檢查的最新進展有更深一層的認識。

Soda Bottle Phantom test for scanner upgrade

posted Dec 3, 2012, 12:02 AM by 林昆儒   [ updated Dec 3, 2012, 12:04 AM ]

臨床試驗最討厭的就是造影設備更新,但是,長期追蹤試驗不可避免的一定會遇到這個問題。
我們的TADNI計畫,當然也會有設備更新的狀況,最近 GE PET 升級就成了練刀的絕佳時機。
依照國外NMI 影像CRO公司的建議,我們在升級前,以及升級後分別得完成了所謂 Soda bottle phantom test.

除此,為了避免遺漏,我們在 2012-12-03 也加做了Hoffman 3-D Brain Phantom phantom study,
以及 striatal phantom study。來確保後續影像品質OK!

現場,蕭老師也作陣指揮

TADNI is now registrated @ ClinicalTrials.gov

posted Nov 13, 2012, 7:25 PM by 林昆儒


今年 (2012) 年中通過衛生署IRB審核後,為期三年的"台灣失智影像三年先期試驗研究" 正式登錄在 Clinical Trials.gov ,為台灣整合性失智研究跨出重要的一步!


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Trial record 1 of 1 for:    01624389
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Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study

This study is currently recruiting participants.
Verified January 2012 by Chang Gung Memorial Hospital
Sponsor:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01624389
First received: June 17, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

Alzheimer's disease (AD) may be one of the most pressing problems facing all countries around the world as the population ages.AD is a slowly evolving process that likes begins years to decades before the clinical symptoms area manifest. However, as one would like to identify the disease process at an earlier point in the clinical continuum, the precision of the diagnosis is reduced. Therefore, the challenge is to try to identify the process at the pre-dementia stage and enhance the specificity of the clinical diagnosis through the use of imaging and other biomarkers. Mild cognitive impairment (MCI) represents an attempt to characterize subjects at an early clinical phase of AD and subjects with MCI have been a target for prevention trials. There are two pathological landmarks, in terms of extra-cellular senile plaques and intracellular neurofibrillary tangles. Although present symptomatic treatments provide some benefit to patients with AD, they are not the solution for AD. Up to date, there are still no therapies can alter the underlying nature of the AD process. Therefore, the earlier the intervention takes place, presumably, the greater the protection against further neuronal damage will be appreciated.The Alzheimer's Disease Neuroimaging Initiate (ADNI) is a consortium of universities and medical centers in the United States and Canada established to develop standardized imaging techniques and biomarkers procedures in normal subjects, subjects with MCI and subjects with mild AD. ADNI has been a groundbreaking project, establishing pre-competitive collaboration and real-time data sharing among academia and industry investigators to clarify the relationships among demographic, genetic, clinical, cognitive, neuroimaging and biochemical measures throughout the course of AD neurobiology, in order to facilitate the development of effective therapeutics.This project has exceeded expectations, providing insights into disease mechanisms as well as hugely valuable advances, based primarily on the use of standardized biomarkers, to drug development programs. A number of the leading disease-modifying drug development programs are now employing ADNI methodology toward more efficient trial design, particularly in the critically important early (pre-dementia) AD population


ConditionIntervention
Alzheimer's Disease
Drug: F18-AV45

Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title:Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Rate of conversion from NC, EMCI, LMCI to AD. [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:200
Study Start Date:January 2012
Estimated Study Completion Date:January 2015
Estimated Primary Completion Date:January 2015 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Experimental: F18-AV45Drug: F18-AV45

This study will recruit a total of 200 evaluable subjects (50 cognitively normal volunteers, 100 MCI, and 50 AD, respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Other Name: F18-AV45

Detailed Description:

Eligibility:

  1. Normal subjects: MMSE scores between 24-30 (inclusive), a CDR of 0, non-depressed, non-MCI, and nondemented, education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years:≥9; 6-15 years: ≥5).
  2. EMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: 9-11; 6-15 years: 5-9), a CDR sum of box of 0.5 (0.5 only in memory subdomain), absence of significant levels of impairment in other cognitive domains, essentially preserved activities of daily living, and an absence of dementia.
  3. LMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4), a CDR of 0.5 with a mandatory requirement of the memory box score being 0.5 or greater, essentially preserved activities of daily living, and an absence of dementia.
  Eligibility

Ages Eligible for Study:  55 Years to 90 Years
Genders Eligible for Study:  Both
Accepts Healthy Volunteers:  Yes
Criteria

Inclusion Criteria:

Enrolled subjects will be between 55-90 (inclusive) years of age, at least 6 years of formal education, and have a study partner able to provide an independent evaluation of functioning. All subjects must be willing and able to undergo all test procedures including neuroimaging and agree to longitudinal follow up. Specific psychoactive medications will be excluded. General inclusion/exclusion criteria are as follows:

  1. Normal subjects: MMSE scores between 24-30 (inclusive), a CDR of 0, non-depressed, non-MCI, and nondemented, education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years:≥9; 6-15 years: ≥5).
  2. EMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: 9-11; 6-15 years: 5-9), a CDR sum of box of 0.5 (0.5 only in memory subdomain), absence of significant levels of impairment in other cognitive domains, essentially preserved activities of daily living, and an absence of dementia.
  3. LMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4), a CDR of 0.5 with a mandatory requirement of the memory box score being 0.5 or greater, essentially preserved activities of daily living, and an absence of dementia.
  4. Mild AD: MMSE scores between 20-26 (inclusive), CDR of 0.5 or 1.0, and meets NINCDS/ADRDA criteria for probable AD, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4)

Exclusion criteria:

Subjects taking antidepressant medications with anticholinergic properties will be excluded, and the regular use of narcotic agents have to be limited to < 2 doses per week within 4 weeks of screening. Neuroleptic medications and other drugs with anticholinergic properties, anti-parkinsonian medications are not allowed within 4 weeks of screening. Diuretic drugs should not be started or need to be discontinued 4 weeks prior to screening. Cholinesterase inhibitors and memantine are permitted if the doses are stable for 4 weeks prior to screening for subjects with MCI and AD. Estrogen and estrogen-like compounds and vitamin E are allowed if the dose have been stable for 4 weeks prior to screening. Participants are required to report any medication changes to the site investigators once they are enrolled in the study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624389

Contacts
Contact: Tzu-Chen YEN, MD,PhD03-3281200 ext 2744yen1110@adm.cgmh.org.tw
Contact: Kun-Ju Lin, MD03-32811200 ext 2625kunjulin@gmail.com

Locations
Taiwan
Tzu-Chen-YenRecruiting
Taoyuan, Taiwan, 333
Contact: Kun-Ju Lin, MD     03-3281200 ext 2625     kunjulin@gmail.com    
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director:Tzu-Chen YEN, MD,PhDNuclear Medicine
  More Information

No publications provided 

Responsible Party:Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:NCT01624389     History of Changes
Other Study ID Numbers:101-1074A1
Study First Received:June 17, 2012
Last Updated:June 17, 2012
Health Authority:Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
[18F]AV-45 PET amyloid binding imaging
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 12, 2012

TADNI PI meeting

posted Nov 9, 2012, 7:37 AM by 林昆儒   [ updated Nov 9, 2012, 7:37 AM ]

經過了好一段時間的醞釀,JIRB,本院IRB,以及衛生署,終於通過了TADNI (Taiwan Alzheimer's Disease Neuroimaging Initiative) 的人體計畫倫理審查,今天在長庚分子影像會議室,由總PI閻紫宸教授主持相關PI meeting並討論收案條件的注意事項。由於其他醫院的IRB仍在審查當中,且部分coPI的倫理學分時數尚待補齊,所以,執行的時程得要往後延一延。

這計畫最困難的地方還是在經費的部分,許多影像檢查,以及神經理學檢查都需要人力以及經費的支持,前一個月才剛將本計畫投稿到NRPB裡,本國家型科技計畫的總目標在於強化中游發展,經臨床前試驗或臨床試驗之驗證與加值,落實研發成果產業化的目標。規劃之短程目標為建構與整合研發體系與能量;中程目標為健全成果管理與產業化推動;長程目標則為培育優質具國際競爭力的生技醫藥人才及產業,並將我國的研發能量及成果推向國際。希望本計畫能獲得支持,否則計畫再周詳,啟動卻是困難重重!

9月21日 國際失智症日

posted Sep 21, 2012, 8:51 AM by 林昆儒   [ updated Sep 21, 2012, 8:52 AM ]

1994年開始,國際失智症協會(ADI, Alzheimer's disease international),每年9月21日訂為國際失智症日(World Alzheimer's Day),結合全世界失智症患者及家屬。 國際失智症協會,在每年9 月 21 日連結全世界71個國家的失智症協會及失智症患者、家屬共同響應為記憶而走等宣導活動,提昇民眾對失智症之認識,並呼籲各國政府及社會大眾重視失智症之預防、治療及照護工作,克服社會對失智症的忽視及標籤化,使失智患者及家屬獲得應得之治療與照顧。 


今年你有什麼活動嗎? 歡迎加入 世界失智活動 登錄 (TADA, Taiwan Alzhemier's Disease Association)


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