Evaluation of Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints: a Double-blinded, Placebo-controlled, Randomization, Multicenter Investigator-initiated Trial

To evaluate the efficacy of choline alphoscerate on improving symptoms related to depression, anxiety, and subjective memory complaints compared to placebo in patients with Major Depressive Disorder(MDD) accompanied with subjective cognitive decline, who are over the age of 60.

开始日期2022-03-01

申办/合作机构

Samsung Medical Center

NCT05383183 / Recruiting临床4期

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine whether combination of donepezil, a cholinesterase inhibitor, with choline alfoscerate has a more favourable clinical profile than monotherapy with donepezil alone.

开始日期2022-01-20

申办/合作机构

Daewoong Bio, Inc.

100 项与甘磷酸胆碱相关的临床结果

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100 项与甘磷酸胆碱相关的转化医学

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100 项与甘磷酸胆碱相关的专利（医药）

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项与甘磷酸胆碱相关的文献（医药）

2024-09-19·BMC Geriatrics

Efficacy and safety of choline alphoscerate for amnestic mild cognitive impairment: a randomized double-blind placebo-controlled trial.

Article

作者: Chang, Jhin Goo ; Kim, Se-Joo ; Lee, Su Young ; Han, Changwoo ; Jeon, Jongwook ; Lee, Seunghoon ; Kim, Woo Jung ; Park, Geum Duck

BACKGROUND:

Effective interventions for overall healthy subjects with mild cognitive impairment are currently limited. Choline alphoscerate (alpha glyceryl phosphorylcholine, αGPC) is a choline-containing phospholipid used to treat cognitive function impairments in specific neurological conditions. This study aimed to investigate the efficacy and safety of αGPC in individuals diagnosed with mild cognitive impairment.

METHODS:

In this multicenter, randomized, placebo-controlled trial, 100 study subjects with mild cognitive impairment underwent a double-blind SHCog™ soft capsule (600 mg αGPC) or placebo treatment for 12 weeks. The primary efficacy outcome included changes from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). Safety assessments included regular monitoring of adverse events, and clinical laboratory tests were conducted at baseline and the end of the trial.

RESULTS:

After 12 weeks of αGPC treatment, the ADAS-cog score decreased by 2.34 points, which was significantly greater than the change observed in the placebo group. No serious AEs were reported, and no study subjects discontinued the intervention because of AEs. There was no significant difference in incidence rate of AEs between the αGPC group and the placebo group.

CONCLUSION:

This study suggests that αGPC is a safe and effective intervention for improving cognitive function in study subjects with mild cognitive impairment.

TRIAL REGISTRATION:

Clinical Research Information Service; Osong (Chungcheongbuk-do): Korea Centers for Disease Control and Prevention, Ministry of Health and Welfare (Republic of Korea); KCT0008797; A 12-week, multicenter, randomized, double-blind, placebo-controlled human application study to evaluate the efficacy and safety of SH_CAPK08 on cognitive function improvement in mild cognitive decline.

2024-07-24·ACS Central Science

Correction to “A Multiscale Study of Phosphorylcholine Driven Cellular Phenotypic Targeting”

作者: Contini, Claudia ; Matias, Diana ; Acosta-Gutiérrez, Silvia ; Forth, Joe ; Rizzello, Loris ; Scarpa, Edoardo ; Duro-Castano, Aroa ; Battaglia, Giuseppe ; Avila-Olias, Milagros ; Gouveia, Virginia M

[This corrects the article DOI: 10.1021/acscentsci.2c00146.].

2024-07-15·ACS Applied Bio Materials

A Physiochemical, In Vitro, and In Vivo Comparative Analysis of Verteporfin–Lipid Conjugate Formulations: Solid Lipid Nanoparticles and Liposomes

Article

作者: Obaid, Girgis ; Shah, Nimit ; Quaye, Maxwell Bortei ; Malkoochi, Ashritha ; Soma, Siddharth Reddy ; Ahmed, Sarah ; Mahmoud, Doha

Visudyne^Ⓡ, a liposomal formulation of verteporfin (benzoporphyrin derivative; BPD), is the only nanomedicine approved to date for photodynamic therapy (PDT). We have previously demonstrated that BPD conjugated to the lysophospholipid 1-arachidoyl-2-hydroxy-sn-glycero-3-phosphocholine (BPD-PC) exhibits the greatest physical stability in liposomes, while maintaining cancer cell phototoxicity, from a panel of BPD lipid conjugates evaluated. In this study, we prepared 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC)-based solid lipid nanoparticles (LNPs) that stably entrap BPD-PC, which resemble the composition of the Spikevax^Ⓡ Moderna COVID-19 vaccine, and compared them to a DPPC based liposomal formulation (Lipo BPD-PC). We evaluated the photochemical, optical, and phototherapeutic properties of both formulations. We also investigated the in vivo distribution and tumor microdistribution of both formulations. Our results demonstrated that Lipo BPD-PC is able to generate 17% more singlet oxygen than LNP BPD-PC, while interestingly, LNP BPD-PC is able to produce 76% more hydroxyl radicals and/or peroxynitrite anion. Importantly, only 28% of BPD-PC leaches out of the LNP BPD-PC formulation during 7 days of incubation in serum at 37 °C, while 100% of BPD-PC leaches out of the Lipo BPD-PC formulation under the same conditions. Despite these differences, there was no significant difference in cellular uptake of BPD-PC or phototoxicity in CT1BA5 murine pancreatic cancer cells (derived from a genetically engineered mouse model). Interestingly, PDT using LNP BPD-PC was more efficient at inducing immunogenic cell death (calreticulin membrane translocation) than Lipo BPD-PC when using IC₂₅ and IC₅₀ PDT doses. In vivo studies revealed that CT1BA5 tumor fluorescence signals from BPD-PC were 2.41-fold higher with Lipo BPD-PC than with LNP BPD-PC; however, no significant difference was observed in tumor tissue selectivity or tumor penetration. As such, we present LNP BPD-PC as a unique and more stable nanoplatform to carry BPD lipid conjugates, such as BPD-PC, with a potential for future photodynamic immune priming studies and multiagent drug delivery.

项与甘磷酸胆碱相关的新闻（医药）

2022-12-20

·Business Wire

World Alzheimer's Disease Therapeutics Analysis Report 2022: 101 Active Drugs - Market Insight, Epidemiology and Pipeline Assessment by Molecule Type, Route of Administration, Pipeline Phase - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Alzheimer's Disease Therapeutics (2022 Edition) - Market Insight, Epidemiology and Pipeline Assessment (By Molecule Type, By Route of Administration, By Pipeline Phase)" report has been added to ResearchAndMarkets.com's offering. Alzheimer's disease Therapeutics Pipeline Analysis has 101 active drugs undergoing several stages of clinical trials. The Alzheimer's disease Therapeutics Pipeline is driven by an increasing gap of unmet need of effective therapeutics that can cure Alzheimer's disease. Additionally, life expectancy has increased due to various healthcare reforms in major economies such as the U.S., Japan, and China. This has resulted in a large geriatric population which is the age group most affected by the disease. Alzheimer's prevalence is rising rapidly and despite decades of research, the disease remains incurable. The majority of therapeutics target symptom reduction and slowing the progression of the disease. The Food and Drug Administration (FDA) approved aducanumab (Aduhelm) for the treatment of certain cases of Alzheimer's disease in June 2021 and this is the first drug approved for Alzheimer's disease in decades. Eisai, Biogen, Hoffmann-La Roche, AZTherapies, Cerecin, Neurotrope, AC Immune, Cassava Sciences, AB Science, Anavex Life Sciences, Athira Pharma, Denali Therapeutics Inc., and other notable companies are developing therapeutic candidates to improve the Alzheimer's Diagnosis and treatment scenario. Scope of the Report The report analyses the Alzheimer's Disease Therapeutics in Pipeline by Molecule Type (Small Molecules, Monoclonal Antibody, Vaccine, DNA/RNA Based, Natural products, Gene Therapy, Cell Therapy, Others). The report analyses the Alzheimer's disease Therapeutics by Route of Administration (Oral, Intravenous, Intramuscular, Subcutaneous, Intrathecal, Intranasal, Other). The report analyses the Alzheimer's disease Therapeutics by Pipeline Phase (Phase I, Phase I/II, Phase II, Phase II/III, Phase III, Phase IV, Preclinical). The report analyses the Pain Management Drugs Market by Availability (Over the Counter (OTC), Prescription). The Alzheimer's Disease Therapeutics Pipeline Analysis has been analysed By Region (Americas, Europe, Asia Pacific, and MEA). The Global Pain Management Drugs Market has been analysed By Region (Americas, Europe, Asia Pacific, and MEA). The key insights of the report have been presented through the leading company shares. Also, the major, trends, drivers and challenges as well as Unmet Needs of the industry has been analysed in the report. The companies analysed in the report include Eli-Lily & Co , Elsal Co., Ltd., BioVie, Johnson and Johnson, Otsuka Pharmaceutical Co., Ltd. H. Lundbeck A/S, Novartis, Cognition Therapeutics, Merck Sharp & Dohme LLC, Biogen. Key Target Audience Alzheimer's Disease Therapeutics Companies End Users (Hospitals and clinics) Research and Development (R&D) Organizations Government Bodies & Regulating Authorities Investment Banks and Equity Firms Key Topics Covered: 1. Introduction 1.1 Alzheimer's Disease Therapeutics Overview 1.2 Scope of Research 2. Executive Summary 2.1 Market Dashboard 2.2 Regional Insights 2.3 Market Ecosystem Factors 3. Research Methodology 3.1 Data Collection Process 3.2 Market Size Calculation-Top-to-Bottom 4. Macro Economic Indicator Outlook 4.1 Global, Region wise GDP Growth 4.2 Global Medical Spending 4.3 Current Healthcare Expenditure 4.4 Pharmaceutical Spending/capita 5. Competitive Positioning 5.1 Companies' Product Positioning 5.2 Competitive positioning 5.2.1 Eli-Lily & Co 5.2.2 Elsal Co., Ltd. 5.2.3 BioVie 5.2.4 Johnson & Johnson 5.2.5 Otsuka Pharmaceutical Co., Ltd. 5.2.6 H. Lundbeck A/S 5.2.7 Novartis 5.2.8 Cognition Therapeutics 5.2.9 Merck Sharp & Dohme LLC 5.2.10 Biogen 6. Alzheimer's disease background 6.1 AD Fact Sheet 6.2 Epidemiology 6.3 Causes and Risk Factors 6.4 Diagnosis and Assessment 6.5 Unmet Needs 7. Therapeutics in Pipeline 7.1 Pipeline Scenario 7.2 Alzheimer's Therapeutics Comparative Review 8. Pipeline Analysis 9. Phase I therapeutics Overview 9.1 LY3372993 9.1.1 Drug Description 9.1.2 Outcomes 9.2 Lu AF87908 9.3 anle138b 9.4 ASN51 9.5 CMS121 9.6 IBC-Ab002 9.7 LX1001 9.8 MK-2214 9.9 MK-8189 9.10 ACU193 9.11 NIO752 9.12 ALN-APP 9.13 TB006 9.14 SNK01 9.15 Pepinemab 9.16 GB-5001 9.17 AC-1202 9.18 SHR-1707 9.19 BEY2153 9.20 JNJ-40346527 9.21 APNmAb005 9.22 NPT 2042 9.23 ALZ-101 10. Phase I/II therapeutics Overview 10.1 Posiphen 10.1.1 Drug Description 10.1.2 Outcomes 10.1.3 Collaborators 10.2 PrimeProT/ PrimeMSKT 10.3 TB006 10.4 RO7126209 10.5 DNL593 10.6 BIIB080 10.7 E2814 10.8 Tdap 10.9 ACI-35.030/ JACI-35.054 10.10 ACI-24.060 10.11 IVL3003 11. Phase II therapeutics Overview 11.1 Lecanemab 11.1.1 Drug Description 11.1.2 Outcomes 11.1.3 Collaborators 11.2 Lomecel-B 11.3 AL002 11.4 AL001 11.5 CT1812 (Elaya) 11.6 APH-1105 11.7 ATH-1017 11.8 T-817MA 11.9 Montelukast buccal film 11.10 ABBV-916 11.11 Bepranemab 11.12 TB006 11.13 LY3372689 11.14 MW150 11.15 EX039 11.16 JNJ-42847922 11.17 REM0046127 11.18 Bryostatin 1 11.19 NanoLithium NP03 11.20 AstroStem 11.21 Gantenerumab 11.22 Semorinemab 11.23 Obicetrapib 11.24 ALZ-801 11.25 CY6463 11.26 Crenezumab 11.27 T3D-959 11.28 PMZ-1620 11.29 GV1001 11.30 ACZ885 11.31 PQ912 11.32 APH-1105 11.33 SLS-005 11.34 Flos gossypii flavonoids 11.35 Human Mesenchymal Stem cells (MSCs) 11.36 JNJ-63733657 11.37 IGC-AD1 11.38 TW001 11.39 ABvac40 12. Phase II/III therapeutics Overview 12.1 Tricaprilin 12.1.1 Drug Description 12.1.2 Outcomes 12.2 ANAVEX2-73 12.3 Piromelatine 12.4 AGB101 13. Phase III therapeutics Overview 13.1 Simufilam 13.1.1 Drug Description 13.1.2 Outcomes 13.1.3 Collaborators 13.2 ATH-1017 13.3 Lecanemab 13.4 Nilotinib BE 13.5 Brexpiprazole 13.6 Masitinib 13.7 Remternetug 13.8 Donanemab 13.9 NE3107 13.10 Gantenerumab 13.11 GV-971 13.12 Aducanumab 13.13 TRx0237 13.14 Semagludtide 13.15 BPDO-1603 13.16 AR1001 13.17 KarXT 13.18 AXS-05 14. Phase IV therapeutics Overview 14.1 Choline Alfoscerate 14.1.1 Drug Description 14.1.2 Outcomes 14.2 Ebicomb 14.3 Rivastigmine 14.4 GV-971 15. Preclinical Phase therapeutics Overview 15.1 PMN310 15.1.1 Drug Description 15.1.2 Outcomes 15.1.3 Collaborators 15.2 PRX123 16. Pipeline analysis, By molecule type 16.1 Alzheimer's Therapeutics Comparative Review, by Molecule type 17. Pipeline analysis, By Route of Administration 17.1 Alzheimer's Therapeutics Comparative Review, By Route of Administration For more information about this report visit https://www.researchandmarkets.com/r/wcw7f7

上市批准临床2期临床1期

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D07349	甘磷酸胆碱	N07AX02	DB04660

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认知障碍	意大利	Italfarmaco SpA	1996-04-03
阿尔茨海默症	-	-	-

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UEGW2014	N/A	肝性脑病	-	Choline alphoscerate (intervention group)	壓鹽遞製糧糧願觸積選(鹹鹽選選獵鹽醖範餘鏇) = 淵窪艱齋築憲鑰鹹蓋鏇廠築製製齋衊鹹夢築構 (夢鑰襯構膚齋選淵鏇醖 ) 更多	-	2014-10-01
				Standard treatment (control group)	壓鹽遞製糧糧願觸積選(鹹鹽選選獵鹽醖範餘鏇) = 糧網壓鬱醖願衊鑰憲鏇廠築製製齋衊鹹夢築構 (夢鑰襯構膚齋選淵鏇醖 ) 更多