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http://med.sina.com/article_detail_103_2_33120.html

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Voyager Therapeutics Announces Positive Results from Ongoing Phase 1b Trial of VY-AADC01 for Advanced Parkinson¡¦s Disease

https://globenewswire.com/news-release/2017/09/06/1108225/0/en/Voyager-Therapeutics-Announces-Positive-Results-from-Ongoing-Phase-1b-Trial-of-VY-AADC01-for-Advanced-Parkinson-s-Disease.html

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The investigational drug, termed VY-AADC-01, will be injected directly into the striatum ( ¯¾ª¬Åé ) during a neurosurgical procedure that is performed with real-time MRI imaging to monitor delivery.

https://clinicaltrials.gov/ct2/show/NCT03065192

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ON or OFF?: Modulating the N-Methyl-D-Aspartate Receptor in Major Depression

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5233677/#!po=25.7576

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http://liawbf.pixnet.net/blog/post/47497203

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1999¦~Elan©MWyeth¨â®a¦X§@¶}µo¥Xªü¯÷®üÀq¥D°Ê§K¬ÌÃĪ«AN-1792¡A¦ýPhase2a¦³18­Ó¯f¤H(6%)µo¥Í¸£½¤ª¢¡A©Ò¥H©ñ±ó¸Ó­pµe¡A§ï±Ä³æ®è§ÜÅé³Q°Ê§K¬Ì¡Abapineuzumab©ó2005¦~¶i¤J¤G´ÁÁ{§É¡Amulticenter, randomized, doubleblind, placebo-controlled, multiple ascending dose study¡C¤j®a³£«ÜÃö¤ß¥¦ªº¦¨±Ñ¡A¦]¬°³o±N¼vÅT¥¼¨Óªü¯÷®üÀqªºªvÀø¤è¦V¡A¥H¤Î²M°£A£] plaques´î½w¯fµ{ªº°²»¡¬O§_¦¨¥ß

In Phase 2, 124 patients with mild to moderate AD received either 0.15, 0.5, 1, or 2 mg/kg of bapineuzumab and 110 received placebo every 13 weeks for an 18-month trial. No significant difference was seen in any of the dose cohorts on either ADAS-Cog or DAD, the two prespecified primary outcomes. Even so, a Phase 3 program was initiated based on prespecified exploratory analyses on pooled treatment groups versus placebo, and on the subpopulation of patients who completed the trial. Also taken into consideration was a post-hoc exploratory efficacy analysis by apolipoprotein ApoE4 carrier status, which hinted at a treatment response in noncarriers.

¤G´ÁÁ{§Éµ²ªG¡A¦U¤p²Õ¥D­nÆ[¹î«ü¼Ð§¡¥¼¨£ÅãµÛ®t²§¡A¦ý¨ÌµM¶i¦æ¤T´ÁÁ{§É¡A¦]¬°¦pªG±N¥|¤p²Õªº¤H¦X¨Ö­pºâ¡AªvÀø²Õ ¡¨showed trends¡¨on the ADAS-Cog(p= 0.078)¡A¡u§¹¦¨¤»°w¡vªvÀøªº¬Ý¨ì®t²§¡AIn the completer population, treatment differences were observed on the ADAS-Cog ( p= 0.003 ),but not on the CDR-SB ( p= 0.159 ),and the MMSE showed only a trend ( p= 0.087 )¡C¦¹¥~¡AÁÙ¦³¤@¶µ¨Æ«á¤ÀªRpost hoc¤ä«ù¥L­Ì¶i¤J¤T´Á¡A´N¬O¥¼±a¦³ApoE4ªº¯f¤H¡A¬Ý°_¨Ó¤ñ±a¦³ApoE4ªº¯f¤H¦³®ÄªG¡A©Ò¥H¤T´ÁÁ{§É³]­p´N¦³¤À¬°ApoE4ªºcarriers¥H¤Înoncarriers¡K¡K

However, there was a trend towards improved scores on the primary outcome measures, leading the authors to pursue post hoc exploratory analyses . To increase statistical pow-er, these exploratory analyses pooled all bapineuzumab-treated patients into a single group, regardless of dose, and a simple comparison of final assessment scores replaced the prespecified model that had assumed a linear rate of disease progression. Still, no statistically significant effect arose in the mITT population. However, in the slightly smaller population of study-completers, significant differences in both ADAS-Cog and DAD,

2008¦~Elan©MWyeth¨M©w±Nbapineuzumab±À¶i¤T´Á¡AÁöµM¨â®a¤½¥q¥X¨¥ÂÔ·V¡A¦ý·~¤º´¶¹M»{¬°¡A¨â®a¤½¥q§@¥X±Ò°Ê¤T´ÁÁ{§É¸ÕÅç·t¥ÜµÛ¡G¡uElan©MWyeth¤w¸g¾Ö¦³¤F¤@¶µ«e´º»¤¤Hªº·s§Þ³N¨ÓÀ³¹ï¦Ñ¦~è§b³o¤@³Ì´Æ¤âªº¯e¯f¡C¡vGoodbodyªÑ²¼¸g¬ö¤HIan Hunter¦b¤@¥÷³Æ§Ñ¿ý¤¤¼g¹D¡A¡u¹ïElan©M´f¤óÂù¤è¦Ó¨¥¡A¥u¦³·í²{¦³¼Æ¾Ú¤w¸gªí©ú±wªÌ¥X²{¤FÅãµÛªºÄpª¬§ïµ½ªº®É­Ô¡A¥L­Ì¤~·|¦Ò¼{±À¶iÃĪ«¶i¤J¤T´ÁÁ{§É¸ÕÅç¡C¡v

§Ú¤£ª¾¹D¨º®É­Ô¦³¨S¦³¤H³o¼Ë»¡¡G¡ubapineuzumab¯à¶i¤J¤T´Á¬O¦]¬°¦³FDA­I®Ñ¡B¨ó§U¡B¦P·N#$^%^@@¡v¡A¨ä¹ê¡A2008¦~¤»¤ë¤~´¦ÅS¤G´Áªì¨B¼Æ¾Ú¡A¦ý¦­¦b2007¦~¨â®a¤½¥q´NÁn©ú­n±À¶i¨ì¤T´Á

2008¦~7¤ë30¤é´¦ÅS¸Ô²Ó¼Æ¾Ú¡A·í±ß¦³½g¤å³¹¡¨Wyeth, Elan and Bapineuzumab -- How to Lie With (Drug) Statistics¡¨¼g¨ì¡G

1.Prospective measures of success are the only accurate way to judge trial results. Honest clinical trials require researchers to specify in advance what they¡¦re looking for -- and by that measure, the bapineuzumab trial was a failure.

2.Post-hoc subgroup analyses amount to lying with statistics. By contrast, a post-hoc analysis involves mining the trial data in order to identify some group of patients who appeared to benefit from the drug. It¡¦s tantamount to moving the finish line after the race is over -- or, as FDA¡¦s Richard Pazdur memorably put it, firing an arrow into the wall and then drawing a target around it.

3.Such findings in subgroups rarely hold up under further study. Or, as the old comput-er-science saying goes, Garbage in, garbage out.

¬ÛÃö¤å³¹«Ü¦h¡A¿é¤JBapineuzumab´N¥i¥H­«·Å¾ú¥v¡A¾ú¥v¯uªº«Ü¦³½ì

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¸òµÛÃÒ¾Ú¨«´N対¤F¡Aantiketamine ketamine ³£¦³®Ä¡C¦ý¬OÀø®Äªº®t§O¦b¨º¡H¨º¦w¥þ©Êªº®t§O¦b¨º»q¡C¦pªG¨â­Ó³£¹LÃö¤F¡A¨º¥«³õªº®t§O´N·|¨M©w¦bÀø®Ä¤Î¦w¥þ©Êªº®t§O
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ketamine ªýÂ_ NMDAR ¥i¥HªvÀø¼~Æ{¯g¡Asarcosine ³o­Ó¼W±jNMDAR¥\¯àªº¡A¤]¥i¥H§Ü¼~Æ{

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Anti-Ketamine¡¦ Agents May Also Ease Depression

http://www.medscape.com/viewarticle/815027

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SND-12¬O¦b2015/11®³¨ìBTD¡A©Ò¥H¤p§Ì²q´ú

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PM405. Sodium Benzoate Add-on Treatment for Refractory Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Trial

Published: 27 May 2016 by Oxford University Press

https://academic.oup.com/ijnp/article/19/Suppl_1/47/2946076/PM405-Sodium-Benzoate-Addon-Treatment-for

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Pharmacokinetics of gallic acid and its relative bioavailability from tea in healthy humans.

https://www.ncbi.nlm.nih.gov/pubmed/11285327

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gallic acid :

Consumption of grape seed extract prevents amyloid-beta deposition and attenuates inflammation in brain of an Alzheimer¡¦s disease mouse.

https://www.ncbi.nlm.nih.gov/pubmed/19384583

Gallic acid is the major component of grape seed extract that inhibitsamyloid fibril formation

https://www.researchgate.net/publication/258042958_Gallic_acid_is_the_major_component_of_grape_seed_extract_that_inhibits_amyloid_fibril_formation

Gallic acid interacts with £\-synuclein (£\-¬ðIJ®Ö³J¥Õ)to prevent the structural collapse necessary for its aggregation.

https://www.ncbi.nlm.nih.gov/pubmed/24769497

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3206174/

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https://www.ncbi.nlm.nih.gov/pubmed/26102198

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https://www.ncbi.nlm.nih.gov/pubmed/21701815

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https://www.ncbi.nlm.nih.gov/pubmed/25505561

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Q1 : ¤ß®®¨ä¥LSNDªº¹êÅç(SND-11 SND-12)¦b¹êÅç¤W¬O·|¦X¨Ö±wªÌ¦Û¤v¥»¨­¥¿¦bªA¥Îªººë¯«¯fÃĪ«¶Ü?

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Q3 : ¦bSND-13¹êÅç±Ô­z , The study will include four parts: a 2 week Screening part, a 4 week run-in

part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension part.

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Q1 : June 30, 2019³o®É¶¡¬O«üpart 1¦³µ²ªGªº®É¶¡ , ÁÙ¬Opart 1 + part 2¹w¦ôªº®É¶¡(¦b¥¼¼W¥[¯f±wªº±ø¥ó¤U)

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Estimated Primary Completion Date: June 30, 2019

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Brain fails in different way

The remedy can be from one mighty source

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In humans, D-serine is the dominant DAA that presents mainly in the CNS and the kid-neys. Since D-serine is a specific co-agonist of NMDAR, DAAO is a critical regulator of NMDARMN by its metabolic role of D-serine.

In developing the NMDA treatment for CNS disorders,

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