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Enrichment Methods for Preparing Tannic Acid Compositions

Abstract

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Example 10.

The Acute Toxicity Study of Tannic Acid from Different Sources

Results

[ ªþµù:Tannic acids were purchased from Sigma (Sigma tannic acid) or made from Enrichment method 10 (Enrichment #10)]

The maximum tolerated dose of Sigma tannic acid was 750 mg/kg.

In Enrichment #10 tannic acid study, all mice received 2000 mg/kg tannic acid displayed decreased activity, arching back, and heavy breathe immediately after dosing, and recovered in 10 minutes.

No adverse effects were observed and the gross autopsy gave no significant finding in all groups.

The maximum tolerated dose of Enrichment #10 tannic acid was at least 2000 mg/kg.

In conclusion,

enrichment #10 tannic acid showed a much higher maximum tolerated dose than Sigma tannic acid and is safer to be used as treatment for CNS and obesity disorders.

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Also within the scope of the present disclosure are (i) any of the tannic acid-containing compositions (e.g., pharmaceutical compositions, health food products, or medical food products) described herein for use in treating an DAAO- and/or glutamatergic neurotransmission-associated disease/disorder, such as those described herein, or for treating an obesity disorder, eating disorder, anorexia nervosa, bulimia nervosa, hyperlipidemia, hyperglycemia, diabetes, or an CNS disorder, and (ii) uses of such composition in manufacturing medicaments for use in treating any of the target diseases/disorders, including those described herein.

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Pharmaceutical

| Fri 06 Apr 2018

Alexandria, April 6 -- Syneurx International (Taiwan) has filed a patent application for compositions containing tannic acids and uses thereof. This invention was developed by Tsai Guochuan Emil, Wang Ching-Cheng, Hsieh Tien-Lan and Mao Yi-Wen. The patent application number is 15/834428. International Patent Classification c..

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Scientists fix genetic risk factor for Alzheimer¡¦s disease in human brain cells

Date: April 9, 2018

Source: Gladstone Institutes

www.sciencedaily.com/releases/2018/04/180409112559.htm

½×¤å :

Gain of toxic Apolipoprotein E4 effects in Human iPSC-Derived Neurons Is Ameliorated by a Small-Molecule Structure Corrector.

Nature Medicine, 2018

DOI: 10.1038/s41591-018-0004-z

www.nature.com/articles/s41591-018-0004-z

¤Æ¦Xª«¥N¸¹ : PH002

¥t¤@½g¦P¹Î¶¤ 2011 ªº½×¤å

Structure-dependent impairment of intracellular apolipoprotein E4 trafficking and its detrimental effects are rescued by small-molecule structure correctors.

www.ncbi.nlm.nih.gov/pubmed/?term=PH002

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[ Microglia Use Filopodia To Help Synapses Grow And Rearrange ]

by D.C. Demetre

March 26, 2018

reliawire.com/microglia-filopodia/

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Sodium Benzoate, a Metabolite of Cinnamon and a Food Additive, Reduces Microglial and Astroglial Inflammatory Responses

www.jimmunol.org/content/183/9/5917

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Cinnamon and Its Metabolite Sodium Benzoate Attenuate the Activation of p21rac and Protect Memory and Learning in an Animal Model of Alzheimer¡¦s Disease

journals.plos.org/plosone/article?id=10.1371/journal.pone.0130398

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¡uSodium benzoate ameliorates subchronic ketamine-induced behavioral disturbances.¡v

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Ketamine is a synthetic dissociative anesthetic. In recent years, it has become a common abused substance.

Heavy ketamine use often results in behavioral disturbances including depression, social deficits and cognitive impairments.

Growing evidence shows that enhancement of NMDA receptor function can ameliorate the effects of ketamine-induced behavioral and neurochemical responses.

Sodium benzoate (SB), an inhibitor of D-amino acid oxidase, can indirectly increase the NMDA receptor function and is also beneficial to the patients with depression or schizophrenia.

The present study examined whether SB can reverse the behavioral dysfunction in mice that repeatedly exposed to ketamine.

Male ICR mice received either ketamine (20 mg/kg, i.p.) or saline twice a day successively during postnatal days (PN) 32-46. Subsequently, SB (30 or 100 mg/kg, i.p.)was given during PN55-69.

The social interaction test, novel object recognition task, three-chamber social test, tail suspension test and forced swimming test were monitored.

Furthermore, a hallucinogenic 5-HT2A agonist 1-[2,5-dimethoxy-4-indophenyl]-2-aminopropane (DOI) was administered to induce head twitch responses.

Our results showed that SB reversed the subchronic ketamine-induced social deficits, memory deficits, depression-like behavior and hyper-responsivity to DOI-induced head twitch responses.

These findings suggest that SB might have potential to reduce negative behavioral consequences of heavy ketamine use.

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Tannic acids effectively inhibited the activity of DAAO.

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(US20180036267) COMPOSITIONS CONTAINING BENZOATE COMPOUND AND TANNIC ACID FOR TREATING CENTRAL NERVOUS SYSTEM DISORDERS

Abstract¡G

¡uCompositions (e.g., pharmaceutical compositions or nutraceutical compositions) comprising a benzoate compound and an excipient, wherein the excipient is tannic acid, and uses thereof for treating central nervous system disorders.¡v

Summary of ivention¡G¡]¸`¿ý¡^

¡uThe present disclosure is based, at least in part, on the unexpected discovery that tannic acid potentiated the therapeutic effects of benzoate salt on symptoms associated with CNS disorders, for example, locomotion activity and sensorimotor function as observed in a mouse model of CNS disease.¡v

Benzoate salt¥[¤W§t¦³Tannic acid ªº½á§Î¾¯¡C

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Low- dose lithium for the treatment of neurodegenerative disorders

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¡uAdd-On Preservative May Improve Outcomes in Refractory Schizophrenia¡v

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doi.org/10.1016/j.biopsych.2017.12.006

Biological Psychiatry Available online 26 December 2017

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Co-crystals of substituted glycine and uses thereof

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¡u CO-CRYSTALS OF LITHIUM BENZOATE AND USES THEREOF¡v

¡u CO-CRYSTALS OF SODIUM BENZOATE AND USES THEREOF¡v

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­ì¨Ó¤w¸g¦³Lithium Benzoate ¬¡©Ê¦¨¤ÀªºÃĪ«Uraseptine Rogier (Lithium Benzoate)

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lithium benzoate unexpectedly showed better pharmacokinetic features and therapeutic efficacies as compared with sodium benzoate and lithium chloride in combination.

the unexpected results that lithium benzoate exhibited protective effects in various in vitro and in vivo CNS disease models

lithium benzoate was used to explore the potential cytoprotective actions against A£]25-35 in primary cortical culture. In addition, the effects of sodium benzoate and lithium chloride on the same condition were also examined, revealing the extraordinary potential efficacy of lithium benzoate on Alzheimer¡¦s disease.

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pubchem.ncbi.nlm.nih.gov/compound/lithium_benzoate#section=Top

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Toxicity :

mouse LD50 oral 1198mg/kg (1198mg/kg) Russian Pharmacology and Toxicology Vol. 33, Pg. 266, 1970.

mouse LD50 subcutaneous 964mg/kg (964mg/kg) Russian Pharmacology and Toxicology Vol. 33, Pg. 266, 1970.

chem.nlm.nih.gov/chemidplus/sid/0000553548

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Page 5¡G¡uThe trial was registered with the number of NCT 01390376.¡v

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Sodium Benzoate, a D-amino Acid Oxidase Inhibitor, Added to Clozapine for the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Trial

www.sciencedirect.com/science/article/pii/S0006322317322977

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¤é¥»¤d¸­¤j¾Ç¾ô¥»Á¾¤G±Ð±Âµ¥¤H¦b2015¦~µoªí¤@½g¤å³¹¡¨ Effects of sodium benzoate on prepulse inhibition deficits and hyperlocomotion in mice after administration of phencyclidine¡¨¡AùØÀY´£¨ì¦]¬°¬Ý¨ì§Ú­ÌSND13ªº¼Æ¾Ú«Üº}«G¡A¦ý«o¨S¦³°Êª«¼Ò¦¡ªº¸ê®Æ¡A©Ò¥H¥L´N°µ¤F­Ó«e¯ß½Ä§í¨îªº¦Ñ¹«¹êÅç¡A¡¨ More recently, Lane et al. performed a randomised, double-blind, placebo-controlled study using SB in stabilised patients with schizophrenia. Given at a dose of 1 g/day for 6 weeks, SB produced a 21% improvement in Positive and Negative Syndrome Scale (PANSS) total scores and large effect sizes in the PANSS total and subscales, Scales for the Assessment of Negative Symptoms (SANSS)-20 items, Global Assessment of Function, Quality of Life Scale, and Clinical Global Impression, as well as improved neurocognition . In addition, SB was well tolerated without significant ad-verse effects. However, there are no reports demonstrating the antipsychotic effects of SB in animal models of schizophrenia, although SB could be a potential therapeutic drug for this disorder¡¨¡A½²±Ð±Â2016¦~¨º½g«p«p¤å³¹«h¼gµÛ ¡¨Our human findings in schizophrenia and mild AD are supported by an animal study showing benzoate¡¦s effects on prepulse inhibition and locomotion disrupted by PCP.¡¨´N¬O«ü¾ô¥»Á¾¤G±Ð±Â°µªºÅçÃÒ¡C

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Recent Findings from Takeda Cambridge Ltd. Has Provided New Information about Clinical Trials and Studies ...

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Assessment of the Target Engagement and D-Serine Biomarker Profiles of the D-Amino Acid Oxidase Inhibitors Sodium Benzoate and PGM030756.

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One approach to activate the co-agonist site is to increase synaptic d-serine levels through inhibition of d-amino acid oxidase (DAO), the major catabolic clearance pathway for this and other d-amino acids.

A number of DAO inhibitors have been developed but most have not entered clinical trials.

One exception to this is sodium benzoate which has demonstrated efficacy in small trials of schizophrenia and Alzheimer¡¦s disease.

Herein we provide data on the effect of sodium benzoate and an optimised Takeda compound, PGM030756 on ex vivo DAO enzyme occupancy and cerebellar d-serine levels in mice.

Both compounds achieve high levels of enzyme occupancy; although lower doses of PGM030756 (1, 3 and 10 mg/kg) were required to achieve this compared to sodium benzoate (300, 1000 mg/kg).

Cerebellar d-serine levels were increased by both agents with a delay of approximately 6 h after dosing before the peak effect was achieved.

According to the news reporters, the research concluded:

Our data and methods may be useful in understanding the effects of sodium benzoate that have been seen in clinical trials of schizophrenia and Alzheimer¡¦s disease and to support the potential clinical assessment of other DAO inhibitors, such as PGM030756, which demonstrate good enzyme occupancy and d-serine increases following administration of low oral doses.

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¤j·§¦b1990¦~John HardyÆ[¹î­ð¤ó¯g«á´£¥Xamyloidªº­P¯f°²³]¡A¥D¾É«áÄòªñ30¦~ªºÃĪ«±´¯Á¤è¦V¡A¦ý¨ä¹ê¦b1988¦~¥ª¥k¡A±K¦è®Ú¤j¾ÇTimothy Greenamyle´N´£¥X¤£¦Pªº·Qªk¡A·Qªk¤§¤@¥]¬A¡u¶}µo¿³¾Ä©ÊÓi°ò»Äªº­P®Ä¾¯¥H«P¶i»{ª¾¥\¯à¡A¦P®Éµ²¦X«á¬ðIJ¨üÅé«ú§Ü¾¯¥H§í¨î¿³¾Ä¯«¸g¬r¯À¡v¡Ait may be possible to exploit EAA agonists as cognition enhancing drugs, by combining their use with agents that block specifically the postreceptor mechanisms responsible for toxicity. «¥­ÌSND¤£´N¬Ocognition enhancing¶Ü¡H²{¦b¤w¸gª¾¹D¿³¾Ä©Ê¯«¸g¬r¯À¬O¤¤±ß´ÁAD¤~­nÃö¤ßªº¨Æ(©Ò¥H¦³menantine)¡A¦­´ÁAD¥Ñ©ó¤j¸£¯«¸g¥h¬r¯Àªº½Õ¸`¥\¯à©|¥¼·l¶Ë¡A©Ò¥H®³SNDªvÀø¦­´ÁAD¤£¥Î¦Ò¼{¿³¾Ä¯«¸g¬r¡A³o¼Ë¬O¤£¬O«Ü¦X²z¡H

¦³®É­Ô¤jÃļt¨«ªº¸ô¤£¨£±o¬O¥¿½Tªº¡A2016¦~Bristol¤j¾ÇPeter Roberts±Ð±Â»¡¡¨ The problem, to my mind, is completely fundamental. There is still no convincing evidence that shows a clear relationship between amyloid deposition and deficits in cognition in humans. All we really know is that evidence of amyloid deposition begins up to maybe 20 years before the onset of Alzheimer¡¦s disease. This might be a good indicator, but does not prove causality¡¨¡A¥L¬Æ¦Ü»{¬°³o¨Ç¤jÃļt¦bamyloid¡Btauªº¨ú¦V¥u¬O»°¬y¦æªº¦Ï¸s®ÄÀ³¡¨they all jump on the bandwagon, unfortunately¡¨

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§Ú¦b±Ð±Â¤å³¹ªºª`ÄÀ§ä¨ì³o½g¨Ó¦Û­Û´°°ê¤ý¾Ç°|¡¨Synaptic NMDA receptor activation stimulates alpha-secretase amyloid precursor protein processing and inhibits amyloid-beta production¡¨

ª½±µ¬Ýµ²½×¡A¡¨We have studied whether stimulation of NMDA receptors, which are key molecular complexes involved in synaptic plasticity and learning and memory processes, influences APP metabolism, and our findings suggest that synaptic NMDA receptor activity promotes APP processing down the nonamyloidogenic £\-secretase generated pathway, while at the same time dampening down A£] production and release.¡¨

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Benzoate and Sorbate Salts: A Systematic Review of the Potential Hazards of These Invaluable Preservatives and the Expanding Spectrum of Clinical Uses for Sodium Benzoate

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§ë¸ê¤H¥i¯à±`¦³³o¼ËªººÃ°Ý¡AÃø¹D¨S¦³¤j¼t§ä¨ì©Î¦X¦¨¸òNabenÃþ¦ü¥\¯àªºDAAO§í¨î¾¯¶Ü¡HÃø¹D¤j¼t¹ï¤¤¼Ï¯«¸g¥ÎÃĨS¦³¿³½ì¡H©ÎªÌ»¡¡A°ê¥~¦U¬ã¨s³æ¦ì¹ïDAAO§í¨î¾¯¯uªº¨º»ò¨S¦³¿³½ì¶Ü¡H

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¡uCompetitive Inhibitors Unveil Structure/Function Relationships in Human D-Amino Acid Oxidase¡v(Ävª§©Êªº§í¨î¾¯´¦ÅS¤F¤HÃþDAAOªºµ²ºc»P¥\¯à¶¡ªºÃö«Y)

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¡uConclusions¡]¸`¿ý¡^

The huge efforts by public and corporate research laboratories to identify novel pharmaceutical drugs to fight schizophrenia symptoms identified hundreds of different hDAAO ligands which in vitro are able to inhibit the human flavooxidase with a potency up to 3 orders of magnitudes higher than classical inhibitors (e.g., benzoate, see Table Table3)..

These compounds were also effective in inhibiting hDAAO activity ex vivo and/or in vivo as demonstrated by measuring residual hDAAO activity in cell lines and tissues from murine models.

Unfortunately, none of the identified hDAAO compounds has yet been approved for schizophrenia treatment (or other diseases).

The main drawbacks of these compounds are the poor bioavailability, high rate of clearance, and poor ability to cross the BBB. Consequently, the observed increase in D-Ser in the CNS observed after administration of such compounds should mainly be due to the systemic increase in the concentration of this D-amino acid caused by inhibiting kidney hDAAO (Hin et al., 2015).

An additional drawback is the fact that the human and murine DAAOs show different biochemical properties and expression patterns.

Consequently, the efficacy, pharmacokinetics, and pharmacodynamic properties of potential hDAAO inhibitors tested in rat, the ¡§standard¡¨ animal model in pharmaceutical research, could be misleading (Frattini et al., 2011; Sasabe et al., 2014).

As a matter of fact, the distribution of hDAAO activity between mouse and human CNS is different as, in the former, the activity of the enzyme is confined to the lower brain. This suggests that cells able to express DAAO may have migrated to the cerebral cortex in concert with the evolution of human forebrain (Sasabe et al., 2014).¡v

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¦]¦¹¡Aµ¹¤©³o¨Ç¤Æ¦Xª««áÆ[¹î¨ìªº¤¤¼Ï¯«¸g¨t²Î¤¤Æ[¹î¨ìªºD-Ser¼W¥[¥D­nÀ³Âk¦]©ó¥Ñ§í¨îµÇhDAAO¤Þ°_ªº³oºØD-®ò°ò»Ä¿@«×ªº¥þ¨­©Ê¼W¥[¡]Hin et al.,2015¡^¡C

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Neurologist Andrew Evans and neurosurgeon Girish Nair, the two doctors who carried out the procedure, said it took several months to plan the operation from scratch and receive approval to go ahead.

The two brain experts created a three-dimensional model of the patient¡¦s brain, which they used to complete "dummy runs" of the operation.

Nair said the slightest mistake in the surgery could have resulted in the death of the patient and injecting the cells too slowly could have resulted in the cells becoming stuck and developing into a tumor.

"The site is very close to the brain stem - the most critical part of the brain - and if you poke around in the wrong places then it could end in paralysis or death," Nair said.

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Evans said it was an enormous relief for the team when scans 24 hours after the surgery revealed the cells had reached all the target sites.

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·|­û¡G²q·Q10136148  µoªí®É¶¡:2017/11/10 ¤W¤È 06:51:39²Ä 200 ½g¦^À³
Sage Therapeutics, Inc. (SAGE)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD

96.65+33.99 (+54.25%). ¥«­È 36 »õ¬ü¤¸

https://finance.yahoo.com/quote/SAGE?ltr=1

2 Antidepressant-Focused Biotech Stocks Are Surging Today. Here¡¦s Why.

https://finance.yahoo.com/news/2-antidepressant-focused-biotech-stocks-174000853.html

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Both trials, Study 202B in severe PPD and Study 202C in moderate PPD, met the primary endpoint of a statistically significant average reduction from baseline in a scale for depression called HAM-D versus placebo at hour 60 (p=0.0242 and p=0.0160, respectively)

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·|­û¡GSeanYang10141436  µoªí®É¶¡:2017/11/9 ¤U¤È 08:25:47²Ä 198 ½g¦^À³
Sage rockets up after two small PhIIIs score in postpartum depression

Two months after getting hammered on the failure of its lead late-stage study for a rare type of seizures, Sage Therapeutics is claiming a victory in a pair of Phase III studies for the same drug in postpartum depression.

Sage reported this morning that both of its late-stage studies for brexanolone (SAGE-547) for major postpartum depression successfully edged out a placebo ¡X but failed to register the big improvement over a sugar pill that was seen in Phase II. And the biotech $SAGE says that it will use the data to back an FDA submission for their drug ¡X which requires a 60-hour infusion ¡X next year.

Sage¡¦s shares spiked 48% in pre-market trading on Thursday.

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http://www.genetinfo.com/investment/featured/item/12168.html

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http://liawbf.pixnet.net/blog/post/47601138-adis-insight%EF%BC%8Clet-there-be-light.

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https://zh.wikipedia.org/wiki/%E5%A4%A7%E8%84%91%E7%9A%AE%E8%B4%A8

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https://zh.wikipedia.org/wiki/%E5%B8%83%E7%BD%97%E5%BE%B7%E6%9B%BC%E5%88%86%E5%8C%BA%E7%B3%BB%E7%BB%9F

D-serine distribution within the human neocortex.

Fig.3

http://pubmedcentralcanada.ca/pmcc/articles/PMC5470653/figure/fig3-1759091417713905/

(a¡Ve) D-serine content in the gray matter of cerebral neocortex was determined using 2D-HPLC. (a) Average of D-serine content was converted into a grayscale heat map and is shown on brain cartoon numbered with Brodmann areas (n = 5). D-serine level in the white area without numbers was not determined. Numbers with # indicate individuals. (b) Individual levels of D-serine are plotted with average ¡Ó SEM for each Brodmann area.

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http://liawbf.pixnet.net/blog/post/47559201

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SND-14

http://liawbf.pixnet.net/blog/post/47570421

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Heterogeneity of D-Serine Distribution in the Human Central Nervous System

http://pubmedcentralcanada.ca/pmcc/articles/PMC5470653/

D-serine is an endogenous ligand for N-methyl-D-aspartate glutamate receptors. Accumulating evidence including genetic associations of D-serine metabolism with neurological or psychiatric diseases suggest that D-serine is crucial in human neurophysiology.

D-Serine is Concentrated in the Human Cerebrum

Heterogeneity of D-Serine Within Cerebral Neocortex is Associated With Brodmann and Functional Areas

Expressional Difference of SR Does Not Affect D-Serine Level in the Neocortex

Given that D-serine is a dominant ligand at glycine-site of synaptic NMDAR in human CNS, modulation of D-serine level in human CNS could be associated with NMDAR activity and regarded as a therapeutic target based on growing evidence of D-serine involvement in CNS diseases, such as stroke (Mustafa et al., 2010; Abe et al., 2014), epilepsy (Harai et al., 2012; Klatte et al., 2013), Alzheimer¡¦s disease (Hashimoto et al., 2004; Wu et al., 2004; Inoue et al., 2008), amyotrophic lateral sclerosis (Sasabe et al., 2007; Mitchell et al., 2010; Sasabe et al., 2012; Martinez et al., 2016), and schizophrenia (Balu et al., 2013; Balu and Coyle, 2015; Cho et al., 2016; Coyle et al., 2016)Although it is controversial if D-serine binding sites are saturated in the mammalian CNS, a number of studies suggest that the sites are not always saturated due to responsiveness by exogenous D-serine (Salt, 1989; Wood et al., 1989; Thiels et al., 1992; Tsai et al., 1998). Together with the fact that neocortical D-serine level is generally much lower in humans than in rodents, the heterogeneity of D-serine distribution in the human cerebral neocortex may influence physiological activity of NMDAR in the local areas.

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Acadia©xºô·s»D½Z¦³´£¨ì¡AFDAµ¹ªºBTD¬O¡u¥¢´¼¬ÛÃöºë¯«²§±`¡vªºBTD¡A¨Ã¤£­­©óªü¯÷®üÀq¥¢´¼¡A¡¨FDA has granted Breakthrough Therapy Designation to pimavanserin for dementia-related psychosis. Dementia-related psychosis includes psychosis in patients with Alzheimer¡¦s disease, dementia with Lewy bodies, Parkinson¡¦s disease dementia, vascular dementia, and frontotemporal dementia¡¨¡A©Ò¥HÀò±oBTDªºÁ{§É¸ê®Æ¤£¥u019study¡A¤]¥]¬A¤§«ePDPªº020study¡A¦]¬°020study¤¤25%¨ü¸ÕªÌ¤w¦³»´«×¥¢´¼¯gª¬¡AThe Breakthrough Therapy Designation for dementia-related psychosis was granted, in part, based on results of ACADIA¡¦s Phase II -019 Study with pimavanserin in Alzheimer¡¦s disease psychosis and results of the company¡¦s Phase III -020 Study with pimavanserin in Parkinson¡¦s disease psychosis.

ir.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&ID=2304720

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https://endpts.com/acadia-adopts-a-new-phiii-game-plan-for-breakthrough-med-dumps-alzheimers-phii/

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"On the plus side, FDA feedback awarding breakthrough designation and allowing for a single pivotal study is encouraging, especially with respect to how the agency views pimavanserin safety.

Moreover, if the study succeeds, the addressable population could be very large, rendering how we currently model the ADP revenue oppty conservative.

However, ACAD¡¦s ¡§basket¡¨ approach to this new ph3 may introduce additional challenges that are simply difficult to handicap:

while the trial works to enrich the placebo-controlled portion for pimavanserin responders, we see the inclusion of such a heterogeneous population in a single pivotal as a risky strategy.

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"Promising Topline Results for Pimavanserin in AD "

http://www.medscape.com/viewarticle/873624

" At week 6, patients taking pimavanserin had a 3.76-point improvement in the NPI-NH Psychosis score compared with a 1.93-point improvement for placebo, representing a statistically significant (P = .0451) comparative improvement. Baseline mean scores were 9.52 and 10.00 for the pimavanserin and placebo groups, respectively.

Atypical antipsychotics have been associated with worsening of cognitive function in patients with AD. Over the course of 12 weeks of treatment in the current study, pimavanserin did not impair cognition as measured by the Mini-Mental State Examination score and was similar to placebo.

On the secondary endpoint of mean change in NPI-NH Psychosis score at week 12, pimavanserin maintained the psychosis improvement seen at the week 6 primary endpoint. This, however, did not statistically separate from placebo."

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Department of Biostatistics UNC at Chapel Hill

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