Nasal Solution Research Articles

On the startup behavior of wormlike micellar networks: The effect of different salts bound to the same surfactant molecule

We report on shear startup data for two wormlike micellar solutions, differing only in concentration and type of two binding aromatic sodium salts. The surfactant molecule is cetylpiridinium chloride at a fixed concentration (100 mM). Sodium salicylate (NaSal) and diclofenac sodium (Diclo) are used as binding salts at concentrations 68 mM NaSal and 52 mM Diclo such that both systems are fully entangled and their linear viscoelastic response is essentially identical. Both systems show the linear response typical of a wormlike micellar solution, with terminal behavior at low frequencies, a well-defined moduli crossover, and a plateau modulus. In the nonlinear regime, however, the behavior of the two systems is totally different, suggesting that the molecular structure difference of the salts and their binding activity to the surfactant molecule are both crucial to determine the fast flow behavior. The NaSal solution shows a very complex rheological response, with strain hardening and very sharp stress peaks, whereas the solution containing Diclo behaves much like ordinary linear polymers, exhibiting pronounced overshoots as well as moderate undershoots in the transient shear viscosity, before approaching the steady state. This polymerlike behavior has also been proved by successfully comparing data with predictions of a constitutive equation recently adopted for both entangled polymers and linear wormlike micelles. As far as NaSal is concerned, a phenomenological model based on rubber network theory is developed, which describes the flow singularities. A physical interpretation of the different behavior in the nonlinear regime is also suggested.

A review of dry eye disease therapies: exploring the qualities of varenicline solution nasal spray

ABSTRACT Introduction Dry eye disease is a prevalent, multifactorial disease characterized by loss of tear film homeostasis. A myriad of ocular therapeutics is commercially available and in development for personalized management of dry eyes. Recently, Varenicline solution nasal spray (VNS) received approval from the US Food and Drug Administration for the treatment of dry eyes. Areas covered This review explores the current mainstay treatments for dry eyes and the role of VNS in addressing unmet needs in the treatment of dry eye disease. A PubMed and MEDLINE keyword search on Tyrvaya and Varenicline nasal solution spray was performed as a part of the inclusion criteria. Varenicline solution nasal spray has been shown to be well tolerated and demonstrated to provide clinically significant improvement in patients with dry eyes Expert opinion Treatment of dry eye disease with VNS may be most beneficial in patients with limited upper-body mobility, dexterity issues, tremors, and glaucoma.

Patência nasal em crianças respiradoras orais

ABSTRACT Several studies have shown the importance of quantitative assessment in nasal patency and functional status of the upper airways to provide clinical and diagnostic information in oral breather individuals, which are of great interest to speech therapy. The aim of the study was to evaluate the effect of nasal saline solution irrigation on the upper airways through nasal aeration and active anterior rhinomanometry in oral breathing children. This was an eight case series study, carried out in children aged 7 to 10 years with an otorhinolaryngological clinical diagnosis of mouth breathing. The study consisted of three stages: (I) initial evaluation; (II) intervention; and (III) final evaluation. The questionnaires of the Index for the Identification of Oral Breathing Signs and Symptoms and disease-specific quality of life in pediatric patients with sinonasal complaints were applied, nasal aeration assessments and the anterior active rhinomanometry exam were carried out. The intervention was performed by irrigating nasal saline solution with 10ml. Afterwards, they were re-evaluated by nasal aeration evaluation and rhinomanometry to compare the results. Regarding nasal aeration and rhinomanometry evaluation, from the 16 comparative measurements between pre and post nasal irrigation, we obtained significant changes in nasal aeration and nasal resistance. Nasal irrigation resulted in improvement in nasal aeration measurements while nasal flow measurements from rhinomanometry remained unchanged considering pre and post nasal irrigation.

Safety and Performance of Narhinel 0.9% Sodium Chloride Monodose and Otrisal 0.74% Sodium Chloride Monodose Nasal Saline Solutions and Nasal Aspirators in Real-World Settings: Postmarket Clinical Follow-up Study Results

Safety and Performance of Narhinel 0.9% Sodium Chloride Monodose and Otrisal 0.74% Sodium Chloride Monodose Nasal Saline Solutions and Nasal Aspirators in Real-World Settings: Postmarket Clinical Follow-up Study Results

Formulation and Development of Cetirizine Hydrochloride Nasal Solution as Intranasal Drug Delivery System

Formulation and Development of Cetirizine Hydrochloride Nasal Solution as Intranasal Drug Delivery System

Do variations in nasal irrigation recipes and storage effect the risk of bacterial contamination?

Make-at-home nasal irrigation solutions are often recommended for treating chronic rhinosinusitis. Many patients will store pre-made solution for convenient use. This study investigated the microbiological properties of differing recipes and storage temperatures. Three irrigation recipes (containing sodium chloride, sodium bicarbonate and sucrose) were stored at 5oC and 22oC. Further samples were inoculated with Staphylococcus aureus and Pseudomonas aeruginosa. Sampling and culturing were conducted at intervals from day 0-12 to examine for bacterial presence or persistence. No significant bacterial growth was detected in any control solution stored at 5oC. Saline solutions remained relatively bacterial free, with poor survival of inoculated bacteria, which may be related to either lower pH or lower osmolality. Storing at room temperature increased the risk of contamination in control samples, particularly from pseudomonas. If refrigerated, pre-made nasal irrigation solutions can be stored safely for up to 12 days without risking cross-contamination to irrigation equipment or patients.

Efficacy and safety of a hypertonic seawater nasal irrigation solution containing algal and herbal natural ingredients in patients with COVID-19.

The objective of this study was to evaluate the efficacy and safety of using a hypertonic seawater nasal irrigation solution comprising natural ingredients (HSS-Plus) with the aim of reducing viral load and ameliorating nasal symptoms in cases of COVID-19. This single-center, prospective, single-arm, low-intervention study evaluated daily use of HSS-Plus in patients admitted to the Sotiria Hospital, Athens, Greece for a period of up to 10 days or until hospital discharge. Viral load measurements in nasopharyngeal swabs were performed on days 0 (baseline), 3 and 6, and on the final day of participation (day 10 ± 2; hospital discharge). In addition, study participants were asked to rate the severity of nasal and other symptoms using Visual Analog Scales (VAS) at the same time points. At the final day, the patients also assessed the perceived use benefit of HSS-Plus. 47 patients were enrolled in the study; 93.6% had a decrease in viral load of at least > 0.5 log10 on day 10 (p<0.001). Compared to values before nasal irrigation, viral load in nasopharyngeal swabs increased immediately after nasal lavage on days 3 (p=0.037) and 6 (p=0.010), indicating efficient removal of viral particles from the nasal cavity. Mean VAS symptoms' total score was reduced from 27.57 ± 15.63 at baseline to 6.73 ± 6.59 after 10 days (p<0.001). Similar reductions were also evident for individual symptoms at all time points (p<0.005). No adverse events were reported in the study. HSS-Plus nasal irrigation is an effective and safe method for reducing viral load and providing symptom relief in patients with COVID-19.

Efficacy and safety of a hypertonic nasal wash solution containing sea algae extracts in patients that underwent surgical correction of a deviated nasal septum and radiofrequency turbinate volume reduction.

The objective of this study was to evaluate efficacy and safety of a Hypertonic Seawater Solution (2.3% NaCl) containing brown and blue-green Algae (HSS-A) in comparison to Isotonic Saline Solution (ISS) regarding the improvement of nasal breathing in patients that have undergone surgical correction of a deviated nasal septum and radiofrequency turbinate volume reduction. A total of 101 individuals were enrolled in the study (HSS-A: 57; ISS: 44). Nasal breathing was evaluated using a Peak Nasal Inspiratory Flow (PNIF) measurement device at four timepoints: prior to surgical intervention (up to 30 days pre-surgery) and at the 2nd, 10th and 20th postoperative days. On the 20th postoperative day, patients also answered a Nasal Surgical Questionnaire (NSQ) evaluating breathing ability and overall satisfaction from the use of both nasal sprays. No significant differences were observed in PNIF measurements between groups at different points. On the 20th postoperative day, NSQ analysis showed that ISS-treated patients had more frequently moderate nasal bleeding compared to the HSS-A group (85.7% vs. 14.3%, p=0.038). No other statistically significant differences were observed between groups. When NSQ parameters were evaluated in a binary mode, a trend for reduced crusting scores was seen in the HSS-A group (15.9% vs. 35.5% in ISS, p=0.053). No safety concerns were reported throughout the study. In patients that have undergone surgical correction of a deviated nasal septum and radiofrequency turbinate volume reduction, PNIF values did not differ significantly in patients receiving HSS-A and ISS solutions. Nasal bleeding was more frequent in ISS patients versus HSS-A. Overall, both solutions provided symptomatic relief and use satisfaction in the absence of side effects.

Post-marketing Surveillance of Long-term Use of Stérimar™ Seawater-based Nasal Irrigation Solutions

Post-marketing Surveillance of Long-term Use of Stérimar™ Seawater-based Nasal Irrigation Solutions

Recommended and verified stability indicating GC–MS procedures for green separation of quaternary mixture of naphazoline, ephedrine, methylparaben, and naphazoline impurity

A GC–MS analytical method, for the estimation of a vasoconstrictive drug combination of naphazoline nitrate and ephedrine hydrochloride, for allergic rhinitis treatment, in the presence of a photo-absorptive anti-bacterial additive (methylparaben) and naphazoline impurity (1-naphthaleneacetic acid), is offered concerning the cutting-edge trend in drug analysis. Environment, cost, and time factors are considered mainly in the establishment of the proposed method. The mixture is analyzed on the highly polar GC stationary phase of (5 % Phenyl Methyl) Silox. The two ions of m/z 209 and 58 were nominated to estimate naphazoline nitrate and ephedrine hydrochloride, correspondingly. Reduction in sample size is achieved by preparing mixture solutions in different drug ratios for calibration curves construction, using ethanol as a typical green solvent referring to its non-toxicity and renewability. The novel and validated chromatographic method is established for the analysis of the two drugs, concurrently in pure form ensuing optimum linearity in the range of 5–30 ppm (r = 0. 99988) for naphazoline nitrate and 15–45 ppm (r = 0. 98865) for ephedrine hydrochloride. The retention times (Rt) of naphazoline nitrate and ephedrine hydrochloride, methylparaben, and 1-naphthaleneacetic acid are 8.7, 3.2, 3.9 & 6.9 min, respectively. Statistical analyses are performed for the validated method, proving the reliability and robustness of the results. The method is successfully applied to analyze the drugs in Deltarhino nasal solution. The method is highly recommended in the quality assurance assessment of the drugs’ raw materials and dosage form. The new GC–MS method is preferred over the old described HPLC one concerning greenness characteristics and reduction of sample size when scanning the greenness characteristics using AGREE and GAPI tools.

Bioactive components of different nasal spray solutions may defeat SARS-Cov2: repurposing and in silico studies.

The recent outbreak "Coronavirus Disease 2019 (COVID-19)" is caused by fast-spreading and highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). This virus enters into the human respiratory system by binding of the viral surface spike glycoprotein (S-protein) to an angiotensin-converting enzyme2 (ACE2) receptor that is found in the nasal passage and oral cavity of a human. Both spike protein and the ACE2 receptor have been identified as promising therapeutic targets to develop anti-SARS-CoV2 drugs. No therapeutic drugs have been developed as of today except for some vaccines. Therefore, potent therapeutic agents are urgently needed to combat the COVID-19 infections. This goal would be achieved only by applying drug repurposing and computational approaches. Thus, based on drug repurposing approach, we have investigated 16 bioactive components (1-16) from different nasal spray solutions to check their efficacies against human ACE2 and SARS-CoV2 spike proteins by performing molecular docking and molecular dynamic (MD) simulation studies. In this study, three bioactive components namely ciclesonide (8), levocabastine (13), and triamcinolone acetonide (16) have been found as promising inhibitory agents against SARS-CoV2 spike and human ACE2 receptor proteins with excellent binding affinities, comparing to reference drugs such as nafamostat, arbidol, losartan, and benazepril. Furthermore, MD simulations were performed (triplicate) for 100ns to confirm the stability of 8, 13, and 16 with said protein targets and to compute MM-PBSA-based binding-free energy calculations. Thus, bioactive components 8, 13, and 16 open the door for researchers and scientist globally to investigate them against SARS-CoV2 through in vitro and in vivo analysis.

Low pH nasal rinse solution enhances mupirocin antimicrobial efficacy.

Chronic rhinosinusitis (CRS) is a common condition negatively impacting a patient's quality of life. It has been hypothesized that bacterial biofilms are involved in the pathogenesis of CRS due to their persistence and difficulty to eradicate with conventional antibiotic therapy. Hence, the topical delivery of antibiotics via nasal rinse solution has gained a lot of attention due to the ability to deliver higher local concentrations, with less systemic absorption and side effects. This study investigates the efficacy of mupirocin dissolved in the 3 most commonly used sinus rinses in Australia Neilmed (isotonic saline), Flo Sinus Care (sodium chloride, sodium bicarbonate, potassium chloride, glucose anhydrous and calcium lactate and Pentahydrate) and FloCRS (sodium chloride, potassium chloride and xylitol). Planktonic and biofilm cultures of S. aureus (ATCC25923, 2 methicillin-resistant S. aureus (MRSA) (C222 and C263), and 2 methicillin-susceptible S. aureus (MSSS) (C311 and C349) clinical isolates) were treated with mupirocin dissolved in three sinus rinses (Neilmed, Flo Sinus Care and FloCRS with different pH). To establish whether pH was a significant factor in determining antibiotic activity, experiments with Flo CRS were performed both at pH 5.64 and elevated pH 7.7. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) were determined for planktonic cells. The biofilm biomass and metabolic activity were assessed by using crystal violet assay and alamarBlue assay respectively. The combination of mupirocin in low pH (pH 5.64) sinus rinse (FloCRS) had the highest efficacy in reducing the growth of S. aureus in both the planktonic and biofilm forms. Mupirocin diluted in FloCRS (pH 5.64) showed a significantly higher reduction in both biomass and metabolic activity than that was observed when mupirocin was diluted in Neilmed, Flo Sinus Care or FloCRS (pH 7.7). The choice of irrigant solution for topical mupirocin delivery appears to be important for antimicrobial activity. The delivery of mupirocin via low pH FloCRS could be useful in eliminating S. aureus biofilms present on the sinus mucosa of patients with CRS.

Effectiveness of pediatric nasal irrigation solution with or without xylitol

Objectives/Hypothesis: The aim of this study was to compare the efficacy and outcome of daily hypertonic saline irrigation versus saline/xylitol for treating pediatric chronic rhinosinusitis (CRS). Study designThis was a prospective, randomized, single-blinded study. MethodsOne hundred and twenty-five children diagnosed with CRS were enrolled in this study. The patients were randomized to twice-daily hypertonic irrigations with saline or saline/xylitol for 6 weeks. The treatment outcomes were measured using: Sinonasal Quality of Life Survey (SN-5) completed at baseline and after 6 weeks of irrigation. ResultsThere were statistically significant improvements in the hypertonic nasal saline group's (reduction in SN-5 domain scores) four domains and an increase in the overall QoL score within each group after 6 weeks of treatment compared to baseline; however, there were no differences in the activity limitation (p = 0.1803). The xylitol solution groups had no differences between the two groups in the SN-5 scores in any of the domains or the overall score at baseline, and post irrigation treatment. ConclusionsDue to low tolerance, compliance, and the side effects, xylitol irrigation is not recommended as a first-line treatment for pediatric CRS. The use of a large volume of low pressure, twice-daily intranasal hypertonic irrigation for 6 weeks is safe and effective in the treatment of pediatric CRS; therefore, it can be used as a baseline treatment for pediatric CRS before considering surgical interventions.

Cocaine: From a Controlled Drug by the DEA to an Approved Drug by the FDA

Abstract: NumbrinoTM, a nasal anesthetic solution based on cocaine hydrochloride, has recently been approved by the FDA for diagnostic procedures and surgery – now, what will be the role of the controlling agencies and the legislation of producing countries to face the imminent medicinal use of cocaine? Would chemistry be the protagonist in proposing alternative approaches to help and overcome this issue? The debate is open with this commentary.

Comparative study between the uses of hypertonic saline versus isotonic saline nasal Irrigation following endoscopic sinus surgery

&lt;b&gt;Introduction:&lt;/b&gt; Various nasal saline solutions have been widely used following endoscopic sinus surgery. Irrigation solutions minimize synechia formation, improve mucosal healing and enhance the removal of infective debris and crusts. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Aim:&lt;/b&gt; This study aims to compare the efficacy of hypertonic and isotonic saline solutions in nasal irrigation following, endoscopic sinus surgery. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Material and methods:&lt;/b&gt; Forty patients who underwent endoscopic sinus surgery were randomly and evenly sorted into: group “A”, which received hypertonic saline nasal irrigation, and group “B”, which received isotonic nasal irrigation The outcomes were assessed for mucociliary clearance (MCT), Lund-Kennedy endoscopic score for crusts and mucosal edema, while nasal obstruction, nasal discharge and facial pain were analyzed by SNOT22, whereby their severity was assessed by means of visual analog score. The patients were followed up for 3 weeks.&lt;/br&gt;&lt;/br&gt; &lt;b&gt;Results:&lt;/b&gt; There was a significant difference in improvement in both groups. Group “A” MCT value on day 7 was P = 0.023, day 14 P = 0.002, and day 21 P = 0.009: for mucosal edema P = 0.009, P = 0.001, P = 0.025; and, for crusts P = 0.015, P = 0.010, P = 0.011: and, for nasal obstruction P = 0.006, P = 0.0001, P = 0.0001 respectively; and for nasal discharge and facial pain P = 0.010, P = 0.047, and P = 0.0062, P = 0.028 for days 14, and 21, respectively. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Conclusion:&lt;/b&gt; Better results in MCT, nasal mucosal edema, crusts, nasal obstruction, discharge, and facial pain/pressure were achieved with the usage of hypertonic saline nasal irrigation.

Low pH nasal rinse solution enhances mupirocin antimicrobial efficacy

Background: Chronic rhinosinusitis (CRS) is a common condition negatively impacting a patient’s quality of life. It has been hypothesized that bacterial biofilms are involved in the pathogenesis of CRS due to their persistence and difficulty to eradicate with conventional antibiotic therapy. Hence, the topical delivery of antibiotics via nasal rinse solution has gained a lot of attention due to the ability to deliver higher local concentrations, with less systemic absorption and side effects. This study investigates the efficacy of mupirocin dissolved in the 3 most commonly used sinus rinses in Australia Neilmed (isotonic saline), Flo Sinus Care (sodium chloride, sodium bicarbonate, potassium chloride, glucose anhydrous and calcium lactate and Pentahydrate) and FloCRS (sodium chloride, potassium chloride and xylitol). Methods: Planktonic and biofilm cultures of S. aureus (ATCC25923, 2 methicillin-resistant S. aureus (MRSA) (C222 and C263), and 2 methicillin-susceptible S. aureus (MSSS) (C311 and C349) clinical isolates) were treated with mupirocin dissolved in three sinus rinses (Neilmed, Flo Sinus Care and FloCRS with different pH). To establish whether pH was a significant factor in determining antibiotic activity, experiments with Flo CRS were performed both at pH 5.64 and elevated pH 7.7. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) were determined for planktonic cells. The biofilm biomass and metabolic activity were assessed by using crystal violet assay and alamarBlue assay respectively. Results: The combination of mupirocin in low pH (pH 5.64) sinus rinse (FloCRS) had the highest efficacy in reducing the growth of S. aureus in both the planktonic and biofilm forms. Mupirocin diluted in FloCRS (pH 5.64) showed a significantly higher reduction in both biomass and metabolic activity than that was observed when mupirocin was diluted in Neilmed, Flo Sinus Care or FloCRS (pH 7.7). Conclusion: The choice of irrigant solution for topical mupirocin delivery appears to be important for antimicrobial activity. The delivery of mupirocin via low pH FloCRS could be useful in eliminating S. aureus biofilms present on the sinus mucosa of patients with CRS.

A Real-World User Survey Study Conducted with a Hypertonic Seawater Nasal Irrigation Solution Comprising Algal and Herbal Ingredients in Patients with Ent Disorders

A Real-World User Survey Study Conducted with a Hypertonic Seawater Nasal Irrigation Solution Comprising Algal and Herbal Ingredients in Patients with Ent Disorders

Major considerations of dental care in COVID-19: an evidence-based on clinical studies and guidelines

Introduction: The COVID-19 pandemic has presented enormous challenges for dentists and patients. The risk of nosocomial transmission is a reality that requires the development of guidelines by the dental community to reduce the chances of infection by the new coronavirus. In this sense, it was necessary to implement alternative prophylactic techniques such as the adoption of oral rinses before dental care. Objective: To present the main considerations of clinical studies on dental care at COVID-19. Methods: The research was carried out from May 2021 to June 2021 and developed based on Scopus, PubMed, Science Direct, Scielo, and Google Scholar, following the Systematic Review-PRISMA rules. The quality of the studies was based on the GRADE instrument and the risk of bias was analyzed according to the Cochrane instrument. Results: One study showed that 0.2% chlorhexidine and 1% povidone-iodine oral solutions are effective pre-procedural mouthwashes against salivary SARS-CoV-2 in dental treatments. It was observed in another study that the effect of reducing the salivary load with mouthwash with CPC and PI was maintained after 6 hours. PVP-I nasal and oral antiseptic solutions are effective in inactivating SARS-CoV-2 at a range of concentrations after exposure times of 60 seconds. There is sufficient in vitro evidence to support the use of antiseptics to potentially reduce the viral load of SARS-CoV-2. The effects against the new coronavirus in vivo still need more randomized clinical trials to prove its effectiveness. Conclusion: ACE2 receptors are highly expressed in the oral cavity, therefore, this could be a potential high-risk route for SARS-CoV-2 infection. The virus can be detected in saliva even before the appearance of symptoms of COVID-19. In this regard, randomized clinical studies have shown that some pre-procedure oral mouthwashes are effective against salivary SARS-CoV-2 in dental treatments. In addition, the American Academy of Implant Dentistry (AAID) reported on how COVID-19 impacts dental care through guidelines for general dentistry.

Profile of Chronic Rhinosinusitis Patients that Undergo Functional Endoscopic Sinus Surgery at Dr. Soetomo General Hospital Year 2015-2019

Background: Rhinosinusitis is an inflammation that occurs in the nose and paranasal sinuses, characterized by two or more symptoms, and one of the symptoms that must be present is nasal obstruction, facial pain, olfactory disturbances, and nasal discharge (anterior, posterior nasal drip). Chronic rhinosinusitis with nasal polyps has 3 different degrees of severity based on the way of treatment, the initial treatment that is always applied to all levels of severity is topical steroid administration, nasal irrigation using NaCl nasal wash solution, and given topical steroids. Methods: This study used a retrospective descriptive method with medical records of patients with chronic rhinosinusitis at The ENT Outpatient Unit Dr. Soetomo General Hospital for the period January 2015 until December 2019. Results: Obtained 99 samples, with details of 72 inclusion samples and 27 exclusion samples due to incomplete data. Conclusion: There are more women than men with majority of young adults, the most common complaint is nasal obstruction, the most common risk factors are allergies and gastric reflux, the highest score of SNOT-22 is 0-22, followed by 23-44, Lund-Kennedy scored the most at 0-4, followed by 5-8, Lund-Mackay scored the most at 5-8 followed by 0-4, most diagnoses are CRS without polyps.

Clinical trial of neuroEPO in mild‐to‐moderate Alzheimer’s disease

AbstractBackgroundNeuroEPO, a nasal pharmaceutical solution of recombinant human erythropoietin with low sialic acid, was in clinical development for the treatment of mild‐moderate Alzheimer’s disease.MethodA double‐blind, randomized, placebo‐controlled, multicenter, prospective, with adaptive design, phase II/III clinical trial involving 174 patients with mild‐to‐moderate Alzheimer’s, was conducted. NeuroEPO or placebo, with different doses, was administered by nasal route 3 times a weeks for 48 weeks. The primary outcome measure was score on the 11‐item cognitive subscale of the Alzheimer’s disease Assessment Scale (ADAS‐cog11, with scores ranging from 0 to 70 and higher scores indicating greater impairment). Secondary outcome measures included Clinician’s Interview‐Based Impression of Change Plus Caregiver Input (CIBIC‐plus), Global Dementia Scale (GDS), activities of daily living (ADL), hippocampal volume change over time (measured with MRI), neuropsychological scales, electroencephalography (EEG) and adverse events.ResultThere were statistically significant differences between neuroEPO and placebo in median change from baseline in the primary outcome at week 48. The change in ADAS‐cog11 scores final‐initial (PP population) for patients in the neuroEPO 0.5 mg (n= 50, median change: ‐ 4.0), neuroEPO 1.0 mg (n=49, median change: ‐ 5.0) and placebo (n=49, median change: 4.0) groups. A difference of 8.0 points CI 95% (6.0; 10.0) neuroEPO 0.5 mg vs. placebo and 9.0 points CI 95% (6.8; 11.2) neuroEPO 1.0 mg vs. placebo at week 48, (p=0.000), was observed. Patients receiving both doses of neuroEPO also showed a significant difference in global improvement (CIBIC‐Plus, p=0.000) and electroencephalography (EEG, p=0.003) compared with placebo group. About hippocampal volume change, 105 patients were analyzed. From them, 58% remained stable and 42% decline hippocampus volume. No serious adverse events related with neuroEPO were reported.ConclusionNeuroEPO improved clinical outcomes in patients with Alzheimer’s disease with good security profile. Therefore, it could be useful in the treatment of these kind of patients.