Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild to moderate Alzheimer's disease (AD) in spite of enormous research efforts. However, these drugs presented as "symptomatic treatment" of AD are considered as having only a weak effect on the course of AD. The reimbursement of these drugs is regularly challenged due to the lack of evidence for the impact of these drugs on milestones stages of AD evolution (survival without severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major consequences in public health (hospitalization and institutionalization). The great majority of previous randomized controlled trials conducted with CI have had a too short duration and the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK, independently of the pharmaceutical industry, showed that the true effect of CI might be more to avoid or to delay the cognitive or functional decline in AD than to improve patients; the institutionalisation (2) was also delayed. However, this trial was conducted in patients with moderate to severe AD, and the interest of the drugs at the mild to moderate stage remains questionable.
The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.

Start Date01 Jun 2024

Sponsor / Collaborator-

ChiCTR2400081930 / RecruitingPhase 4IIT

A real-world study of the safety and efficacy of galanthamine hydrobromide in the treatment of cognitive impairment

Start Date15 Mar 2024

Sponsor / Collaborator-

NCT04769206 / RecruitingPhase 1/2IIT

Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans

Specific Aim 1: To test the hypothesis that prolonged (3-month) treatment with galantamine inhibits NADPH IsoLG-protein adducts formation and improves markers of endothelial cell (EC) dysfunction in AAs.
Aim 1a: The investigators will determine if galantamine inhibits NADPH IsoLG-protein adducts formation, superoxide production, and immune cell activation compared to placebo.
For this purpose, the investigators will study peripheral blood mononuclear cell (PBMC), a critical source of systemic oxidative stress, collected from study participants.
Aim 1b: The investigators will determine if galantamine reduces intracellular Iso-LGs, ICAM-1, and 3-nitrotyrosine, a marker of vascular oxidative stress, in ECs harvested from study participants.
Specific Aim 2: To determine if prolonged (3-month) treatment with galantamine improves endothelial dysfunction as measured by vascular reactivity in AAs. The investigators will measure vascular reactivity in response to ischemia in two vascular beds: (a) in conduit arteries (brachial artery) using brachial artery diameter flow-mediated dilation (FMD), and (b) in the microvasculature (MBV) using contrast-enhanced ultrasonography in skeletal muscle.
This proposal will study a novel mechanism that could alter the oxidative and immunogenic responses that contributes to endothelial dysfunction in AAs and will offer a potential pathway for the development of more effective therapies aimed at decreasing the progression of endothelial dysfunction to cardiovascular disease in this population.

Start Date20 Dec 2021

Sponsor / Collaborator

Vanderbilt University Medical Center

100 Clinical Results associated with Galantamine Hydrobromide

100 Translational Medicine associated with Galantamine Hydrobromide

100 Patents (Medical) associated with Galantamine Hydrobromide

2,418

Literatures (Medical) associated with Galantamine Hydrobromide

01 Mar 2024·Bioorganic chemistry

A comprehensive review of multi-target directed ligands in the treatment of Alzheimer’s disease

Review

Author: Kabra, Uma D ; Pathak, Chandni

Alzheimer's disease (AD) is the most common form of dementia affecting specifically older population. AD is an irreversible neurodegenerative CNS disorder associated with complex pathophysiology. Presently, the USFDA has approved only four drugs viz. Donepezil, Rivastigmine, Memantine, and Galantamine for the treatment of AD. These drugs exhibit their neuroprotective effects either by inhibiting cholinesterase enzyme (ChE) or N-methyl-d-aspartate (NMDA) receptor. However, the conventional therapy "one target, one molecule" has failed to provide promising therapeutic effects due to the multifactorial nature of AD. This triggered the development of a novel strategy called Multi-Target Directed Ligand (MTDL) which involved designing one molecule that acts on multiple targets simultaneously. The present review discusses the detailed pathology involved in AD and the various MTDL design strategies bearing different heterocycles, in vitro and in vivo activities of the compounds, and their corresponding structure-activity relationships. This knowledge will allow us to identify and design more effective MTDLs for the treatment of AD.

01 Mar 2024·Bioorganic chemistry

Synthesis, biochemical and computational evaluations of novel bis-acylhydrazones of 2,2′-(1,1′-biphenyl)-4,4′-diylbis(oxy))di(acetohydrazide) as dual cholinesterase inhibitors

Article

Author: Ullah, Samee ; Abdalla, Ashraf N ; Ali, Sajid ; Ibrahim, Muhammad ; Al-Harrasi, Ahmed ; Halim, Sobia Ahsan ; Khan, Ajmal ; Ahmad, Manzoor ; Latif, Abdul ; Khalid, Asaad ; Ali, Mumtaz

A series of twenty-seven bis(acylhydrazones) were successfully synthesized with high yields through a multistep process, which entailed the esterification of hydroxyl groups, hydrazination with an excess of hydrazine hydrate, and subsequent reactions with various carbonyl moieties (aldehydes). In the final stage of synthesis, different chemical species including aromatic, heterocyclic, and aliphatic compounds were integrated into the framework. The resulting compounds were characterized using several spectroscopic techniques (¹H NMR, ¹³C NMR, and mass spectrometry). Their anticholinesterase activities were assessed in vitro by examining their interactions with two cholinesterase enzymes: acetylcholinesterase (AChE) and butyrylcholinesterase (BChE). Among the synthesized hits, compounds 3, 5, 6, 9-12, and 14 exhibited good to moderate inhibition of AChE. Specifically, 10 (IC₅₀ = 26.3 ± 0.4 μM) and 11 (IC₅₀ = 28.4 ± 0.5 μM) showed good inhibitory activity against AChE, while 9, 12, 3, and 6 exhibited significant inhibition potential against AChE with IC₅₀ values ranging from 35.2 ± 1.1 μM to 64.4 ± 0.3 μM. On the other hand, 5 (IC₅₀ = 22.0 ± 1.1 μM) and 27 (IC₅₀ = 31.3 ± 1.3 μM) displayed significant, and 19 (IC₅₀ = 92.6 ± 0.4 μM) showed moderate inhibitory potential for BChE. Notably, 5 and 27 exhibited dual inhibition of AChE and BChE, with greater potency than the standard drug galantamine. The binding patterns of these molecules within the binding cavities of AChE and BChE were anticipated by molecular docking which showed good correlation with our in vitro findings. Further structural optimization of these molecules may yield more potent AChE and BChE inhibitors.

01 Feb 2024·Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology

The effects of different acetylcholinesterase inhibitors on EEG patterns in patients with Alzheimer’s disease: A systematic review

Review

Author: Vestergaard Nieland, John D ; Goozee, Kathryn G ; Vaseghi, Salar ; Arjmandi-Rad, Shirin

OBJECTIVE:

Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the most common type of dementia. The early diagnosis of AD is an important factor for the control of AD progression. Electroencephalography (EEG) can be used for early diagnosis of AD. Acetylcholinesterase inhibitors (AChEIs) are also used for the amelioration of AD symptoms. In this systematic review, we reviewed the effect of different AChEIs including donepezil, rivastigmine, tacrine, physostigmine, and galantamine on EEG patterns in patients with AD.

METHODS:

PubMed electronic database was searched and 122 articles were found. After removal of unrelated articles, 24 articles were selected for the present study.

RESULTS:

AChEIs can decrease beta, theta, and delta frequency bands in patients with AD. However, conflicting results were found for alpha band. Some studies have shown increased alpha frequency, while others have shown decreased alpha frequency following treatment with AChEIs. The only difference was the type of drug.

CONCLUSIONS:

We found that studies reporting the decreased alpha frequency used donepezil and galantamine, while studies reporting the increased alpha frequency used rivastigmine and tacrine. It was suggested that future studies should focus on the effect of different AChEIs on EEG bands, especially alpha frequency in patients with AD, to compare their effects and find the reason for their different influence on EEG patterns. Also, differences between the effects of AChEIs on oligodendrocyte differentiation and myelination may be another important factor. This is the first article investigating the effect of different AChEIs on EEG patterns in patients with AD.

News (Medical) associated with Galantamine Hydrobromide

03 Jun 2024

·www.globenewswire.com

Nika Pharmaceuticals, Inc. (NIKA) Presents Its Business Strategy

HENDERSON, Nev., June 03, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NIKA) introduces its plans to develop the company into a sustainable business project that will consistently grow, bring good profits and provide dividends to its shareholders. To achieve its goals, NIKA will work towards the construction of three pharmaceutical facilities: A factory for the production of drugs in injection formA factory for the production of drugs in tablet formA factory for the production of dietary supplements On May 9, 2024, NIKA became the beneficial owner of a production building valued at $2,045,209 that was previously purchased and renovated by CEO Dimitar Savov. There, the factory for drugs in injection form is under construction according to GMP standards and will be finished by December 31, 2024. NIKA’s subsidiary, Nika Europe, Ltd., has signed a Supply Agreement and put a down payment for a brand-new vial production line equipment. The full capacity of the production facility will be 18,000 vials per hour, which will result in a maximum yearly production capacity of 3,500,000 sets of ITV-11. The retail price of one set of ITV-1 will be 3,300 EUR (around $3,500), from which there will be a net profit of around $1,600, with Nika receiving $1,120 in net profit, with the remaining $480 going to Immunotech Laboratories BG. On August 1, 2022, NIKA signed a Joint Business Agreement with Immunotech Laboratories BG, which holds the exclusive rights for production and distribution of ITV-1 and has completed a clinical trial on AIDS patients showcasing great treatment results (See Final Report). The agreement’s goal is to combine efforts to realize the registration, production and distribution of medicinal products based on the Inactivated Pepsin Fraction (“IPF”). NIKA estimates to initially start at a 30% production capacity in 2025, which should generate a net profit of around 1.176 billion USD by the end of 2025, whilst working towards a gradual production rate increase of up to 90% of the maximum capacity by the end of 2026. NIKA currently has signed distribution agreements with strategic partners who have been provided with exclusive distribution rights for the ITV-1 treatment for AIDS on the territories of the UAE, Ukraine, Iraq, Jordan, and Syria. There are ongoing negotiations for exclusive distribution rights for additional countries including Nigeria, as NIKA strives to choose the most suitable partners. “Thanks to my personal contacts in Europe, Asia, and Africa, and Bulgaria’s strategic location, Nika Pharmaceuticals has a great prospect of choice of strategic partners,” stated Savov. Bulgaria’s EU membership also provides NIKA with a direct access to a 450 million market. “Since ITV-1 has shown great treatment results and is compatible with other currently used drugs for the treatment of AIDS, ITV-1 will serve as a great supplementary tool in the battle against AIDS. Due to its wide-spectrum antiretroviral action, ITV-1 can also be useful in the treatment of other viral-based diseases,” continued Savov. Given that more than 50% of the drugs worldwide are generic, NIKA purchased the technologies and full registration dossiers for the production of generic form of VINPOCETINE 10mg, MENTHYL VALERATE 60mg, METAMIZOLE SODIUM 500mg (See April 15 PR). NIKA is exploring options for suitable buildings for a factory for production of drugs in tablet form and will announce specific details once a final decision is made. NIKA has since purchased a full dossier for GALANTAMINE HYDROBROMIDE 5mg, used in the treatment of forms of dementia, and continues to explore other technologies for the production of generic drugs. The company strives for its portfolio to include treatments for the most common and significant diseases. “We are negotiating to acquire a half-built factory for dietary supplements, as NIKA now has 11 dietary supplements in its portfolio, six of which, namely Physiolong, Carotilen, Hypocholestin, Biodetoxin, Anthocylen C and Silymaron, have shown useful properties and are already on the market in Bulgaria, whilst we are working to launch wider distribution in the entire European Union, Asia, and Africa,” explained Savov. NIKA is preparing a comprehensive business plan, which will include detailed information and estimates for the company’s development in the next five years. “I believe that this informal business strategy will be a good way for investors to understand the mindset of the management of our company, as every shareholder, no matter the size of their ownership, is equally valuable to us. I want to thank our shareholders once more for giving their trust in our company,” concluded Savov. About Nika Pharmaceuticals, Inc. Nika Pharmaceuticals, Inc. (NIKA) is a pharmaceutical company, specializing in the treatment of HIV/AIDS, Hepatitis B and C, Rheumatoid Arthritis, Cancer, Diabetes, and all diseases, for which strengthened cell immunity is of vital importance. NIKA’s intellectual property includes six drugs in injection form – two of which have successfully undergone clinical trials with good treatment results – four drugs in tablet form, and eleven dietary supplements. NIKA’s goal is to not only achieve corporate profits, but to provide better and easier access to life-saving medicinal drugs and useful dietary supplements. Find more on www.nikapharmaceuticals.com. Forward-looking Statement: This press release contains forward-looking statements. Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements.” These forward-looking statements generally are identified by the words “believes,” “expects,” “anticipates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will likely result,” and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. ________________________ 1 Assuming a 10-hour work day with 26 active working days on average per month, the factory will produce 56,000,000 vials per year at maximum capacity, which equals 3,500,000 sets containing 16 vials each.

License out/in

18 Apr 2024

·www.pharmaceutical-technology.com

Essential Pharma acquires Reminyl from Janssen Pharmaceutica

Reminyl is intended to treat mild to moderately severe dementia of the Alzheimer type. Credit: Hryshchyshen Serhii / Shutterstock.com. Speciality pharmaceutical group Essential Pharma has concluded the acquisition of Reminyl oral capsules from Johnson & Johnson company Janssen Pharmaceutica. The strategic move enhances Essential Pharma’s portfolio of central nervous system (CNS) medicines and expands its global footprint, particularly in Asia-Pacific. A cholinesterase inhibitor, Reminyl is an established CNS drug for mild to moderately severe dementia of the Alzheimer type. Essential Pharma will now hold rights to Reminyl in the European Economic Area, South Korea, Thailand and all other existing markets for this product. The deal excludes the UK and Ireland, Japan and Latin America. See Also: Inaticabtagene autoleucel by Juventas Cell Therapy for Acquired (Autoimmune) Hemolytic Anemia: Likelihood of Approval Ulixacaltamide hydrochloride by Praxis Precision Medicines for Essential Tremor: Likelihood of Approval The acquisition aligns with Essential Pharma’s focus on CNS, gastroenterology, ophthalmology and rare diseases. Essential operates in more than 70 countries and is supported by healthcare investment firm Gyrus Capital. Essential CEO Emma Johnson stated: “Our acquisition of rights to Reminyl in these markets will ensure Alzheimer’s patients and caregivers in those regions have continued access to this vital medicine. “The acquisition represents a significant and synergistic addition to our concentrated portfolio of CNS products, further expanding our global presence and solidifying our position as a leading speciality pharma group.” The latest development comes after Essential Pharma acquired clinical-stage pharmaceutical company Renaissance Pharma for an undisclosed sum in April 2024. Renaissance develops treatments for paediatric rare diseases, with its lead asset, Hu14.18K322A, currently being analysed in a Phase II clinical trial to treat high-risk neuroblastoma.

Phase 2Cell TherapyAcquisitionPhase 1

18 Apr 2024

·www.pharmaceutical-technology.com

Inflammation among current dementia research focus, says Alchemab CSO

Alchemab CSO Jane Osbourn also believes a more holistic approach to dementia care beyond drug treatment is needed. Credit: Getty images/ TEK IMAGE/Science Photo Library. Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab. Osbourn was speaking on a panel discussing novel approaches to treat neurodegeneration at the 2024 Anglonordic Life Science Conference being held in London, UK on 18 April. She outlined that the past five to 10 years have led towards a better understanding of dementia’s causes. “Obviously one cause is toxic protein aggregation, which has been a hypothesis for decades and is being addressed, but we’re starting to see more understanding of other causes such as inflammation, cell metabolism and neuronal health, and I think those are the areas that will now form the next wave of products that can then be used in combinations. “I think understanding the causes, and what we are doing as an industry about them – such as whether we can do anything about neuronal health or making the brain more resilient against inflammation – are just some of the questions under consideration at this time.” See Also: RG-6315 by Genentech USA for Inflammation: Likelihood of Approval Ftortiazinon by Gamaleya Federal Research Center of Epidemiology and Microbiology for Urinary Tract Infections: Likelihood of Approval On the collaborative nature of being able to get cohorts together, Osbourn added: “I think in recent times there’s been a step change in collaboration and consortia, and getting patients to enable biomarkers, diagnosis and trials, which is going to really help in gaining further insights.” Osbourn highlighted the impact of ageing dementia populations. “Ageing is a risk for neurodegeneration, and we’re all becoming much more aware of the significance of that in terms of the impact on patients, carers, and society. I think there’s a massive societal risk around the dementia population ageing in terms of how they integrate with society. “Society is built for people who are able, have memory, can use online tools – and one of my personal concerns is around a need to look more closely at how we are supporting people through dementia; not just by drugs but in a more holistic way.” Speciality pharmaceutical group Essential Pharma recently completed the acquisition of Reminyl oral capsules from Johnson & Johnson company Janssen Pharmaceutica. Reminyl is an established central nervous system (CNS) drug for mild to moderately severe dementia of the Alzheimer type. Sabirnetug is a humanised, monoclonal antibody under clinical development by Acumen Pharmaceuticals and currently in Phase I for Dementia Associated With Alzheimer’s Disease.

Phase 1Acquisition

100 Deals associated with Galantamine Hydrobromide

External Link

KEGG	Wiki	ATC	Drug Bank
D02173	Galantamine Hydrobromide	N06DA04	DB00674

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alzheimer Disease	US	Janssen Pharmaceuticals, Inc.	28 Feb 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Mar 2003
Schizophrenia	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Mar 2003
Lewy Body Disease	Phase 3	US	GNRC Hospitals Ltd.	01 Dec 2002
Neurocognitive Disorders	Phase 3	-	Janssen-Cilag SpA	01 Aug 2001
Dementia, Vascular	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 1998
Pick Complex	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2003
Pick Disease of the Brain	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2003
Fasting	Phase 1	-	Dr. Reddy's Laboratories Ltd.	01 Oct 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03547622 (CTgov)	Early Phase 1	-	6	galantamine (MAT Taper With Galantamine)	rqctkaluyb(huiirhcbhw) = fnkwfcoqsd blujrltvwk (msezaannjm, oncokbllhc - mrthaehjqe) View more	-	19 Aug 2022
				placebo (MAT Taper With Placebo)	rqctkaluyb(huiirhcbhw) = zhoihsmyjb blujrltvwk (msezaannjm, ebosfvfoju - ohqvnvnpzr) View more
NCT01100775 (CTgov)	Phase 2	Schizophrenia	12	Galantamine (Galantamine)	vjapjqbrvx(ferwmkenhj): P-Value = 0.898; P-Value = 0.701; P-Value = 0.16; P-Value = 0.701 View more	-	08 Jun 2022
				placebo (Placebo)
NCT00176423 (CTgov)	Phase 4	Schizophrenia \| Cognitive Dysfunction \| Schizoaffective disorder	117	Galantamine (Galantamine)	rispxrhifm(svjpomaesj): P-Value = <0.05 View more	-	16 Dec 2020
				Galantamine (Placebo)
NCT02365285 (CTgov)	Phase 1/2	Obesity	23	Galantamine (Galantamine 16 mg (African-American))	cfskhwlefc(ohelhvzmsx) = xtjfazqpyt uaplsbgaji (nckdzvskes, oafoqjbbzr - gpmdtnrcbv) View more	-	19 Mar 2019
				Galantamine (Galantamine 16 mg (White))	cfskhwlefc(ohelhvzmsx) = widqnkbxej uaplsbgaji (nckdzvskes, smolwdodsi - qbbqwyjxhp) View more
NCT01669538 (CTgov)	Phase 2	Tobacco Use Disorder	98	Galantamine (Galantamine)	uvzuvfmyre(ymhkjkmudy) = lavomrbzih qwytwubvdv (jpllygwmtk, bamufmppvf - ivawhzzkgb) View more	-	15 Feb 2019
				Placebo (Placebo)	uvzuvfmyre(ymhkjkmudy) = doegyujurg qwytwubvdv (jpllygwmtk, iztwcxzeff - obrwgcgnbv) View more
NCT01531153 (CTgov)	Not Applicable	-	93	Placebo+Galantamine (Placebo)	ajegtbkthu(nvcdirxput) = futhullovi kweqkqeiuu (ztaxwaojxu, erwrvolkkg - klsrqskaoe) View more	-	26 Oct 2018
				Galantamine (Galantamine 8mg)	ajegtbkthu(nvcdirxput) = riwjuroruq kweqkqeiuu (ztaxwaojxu, zidlklnkfy - yikntkuspm) View more
NCT02420327 (CTgov)	Not Applicable	-	43	Placebo patch & placebo capsule (Placebo Patch and Placebo Capsule)	wgomtcvgwa(qfewmjpkij) = oiolgizult ddjtgyovai (nxfttviffj, yqrmfmdlov - bzcqcictvf) View more	-	17 Aug 2018
				Nicotine patch & placebo capsule (Nicotine Patch and Placebo Capsule)	wgomtcvgwa(qfewmjpkij) = tsizaivbyw ddjtgyovai (nxfttviffj, zkpobufaoh - wohagapnkb) View more
NCT00809835 (CTgov)	Phase 2	Cocaine-Related Disorders	120	CBT+Galantamine (Galantamine and CBT)	hcwbmhzyfj(gcybvfbvie) = dddxsnkkie vazqvoeyuh (prxsampphc, khelkbfbdx - ksxmouxkrc) View more	-	12 Jun 2017
				Galantamine (Galantamine)	hcwbmhzyfj(gcybvfbvie) = lgilbwohan vazqvoeyuh (prxsampphc, ckdcnsaqvp - smnyxyjgdx) View more
NCT01012167 (CTgov)	Phase 2	Cognitive Dysfunction \| Schizophrenia	86	Placebo-Galantamine	epixufgjsb(cfqgizlfmg) = qbypjrcwbi gxdcubmfka (bomayivbkw, xtkprwdljq - cuefmwfnct) View more	-	02 Jun 2017
NCT00741598 (CTgov)	Phase 4	Bipolar Disorder	72	Galantamine-ER	vnzyyrlesf(rbxeueysxr) = btqumozynh hsopntmlkl (eisnnjgntt, mtexdfzshi - cqhiuvpgoi) View more	-	02 May 2017

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