Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this open-label study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

Start Date29 Oct 2024

Sponsor / Collaborator

University of Michigan

[+1]

NCT06626152

/ RecruitingPhase 2IIT

Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial

Background
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory.
Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD.
Methods
In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks.
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge.
The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory.

Start Date15 Aug 2024

Sponsor / Collaborator

University of British Columbia

[+1]

NCT06219915

/ CompletedPhase 1/2IIT

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System

Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this double-blinded, placebo-controlled study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

Start Date15 Mar 2024

Sponsor / Collaborator

University of Michigan

[+1]

100 Clinical Results associated with Carbidopa

100 Translational Medicine associated with Carbidopa

100 Patents (Medical) associated with Carbidopa

3,707

Literatures (Medical) associated with Carbidopa

01 Mar 2025·BEHAVIOURAL BRAIN RESEARCH

Taurine, an essential amino acid, attenuates rotenone-induced Parkinson’s disease in rats by inhibiting alpha-synuclein aggregation and augmenting dopamine release

Article

Author: Oyovwi, Obukohwo M ; Ajayi, Abayomi M ; Nekabari, Miracle K ; Onuelu, Jackson E ; Fokoua, Aliance R ; Ben-Azu, Benneth ; Ojezele, Matthew O ; Adebayo, Olusegun G ; Ozah, Esther O ; Omogbiy, Itiviere A ; Iwhiwhu, Prosper ; Eduviere, Anthony T

Reducing antioxidant levels exacerbates the generation of reactive oxygen/nitrogen species, leading to alpha-synuclein aggregation and the degeneration of dopaminergic neurons. These play a key role in the onset of Parkinson's disease (PD), for which effective treatment remains elusive. This study examined the neuroprotective effects of taurine, an essential β-amino acid with antioxidant and antiinflammation properties, in Swiss male mice exposed to rotenone-induced PD. Mice (20-25 g) were grouped into seven groups (n = 9) and treated with taurine alone (5, 10 and 20 mg/kg, p.o) or levodopa (10 mg/kg, p.o) for 28 consecutive days following intraperitoneal co-administration of rotenone (1.5 mg/kg, in 5 % dimethylsulfoxide) for 14 alternate days. Open-field, rota-rod and hanging-wire motor performance and coordination tests were conducted on days 26-28. Oxidative stress and neuroinflammatory markers; levels of acetylcholinesterase enzyme activity, dopamine, and alpha-synuclein were assayed in the striatal and prefrontal-cortical regions alongside histological examinations. Rotenone significantly reduced latency to fall and akinesia-like behavior with several slip/error relative to vehicle groups. Taurine increased the latency to fall, notably improving motor coordination, locomotor deficit, and neuromuscular competence. Also, rotenone significantly increased malondialdehyde and nitrite; while decreasing acetylcholinesterase activity, glutathione, catalase, superoxide-dismutase, and glutathione-S-transferase levels in the striatum and prefrontal-cortex respectively, which were attenuated by taurine. Taurine increased dopamine levels in the striatum and prefrontal cortex dose-independently. Like carbidopa, taurine decreased alpha-synuclein, tumor-necrosis factor-α and interleukin-6 levels in the striatum and prefrontal-cortex. Additionally, taurine-reversed rotenone-induced neurodegeneration in the striatum and prefrontal cortex indicates neuroprotective function. Conclusively, taurine attenuates rotenone-induced PD-like behavior by enhancing the brain's antioxidant system, inhibiting pro-inflammatory cytokine release, reducing α-synuclein formation, and augmenting dopaminergic release in mice's brains.

01 Mar 2025·PARKINSONISM & RELATED DISORDERS

Long-term, continuous, subcutaneous levodopa/carbidopa infusion with ND0612 in Parkinson's disease: 3-year outcomes from the open-label BeyoND study

Article

Author: Vasquez, Alberto ; Rudzińska, Monika ; Lopes, Nelson ; Kumar, Rajeev ; Roullet-Solignac, Isabelle ; Case, Ryan ; Muhlack, Siegfried ; Stocchi, Fabrizio ; Isaacson, Stuart ; Aldred, Jason ; Simuni, Tanya ; Greenberg, Jeffrey ; Taylor, Danette ; Azulay, Jean-Philippe ; Antonini, Angelo ; Yardeni, Tami ; Struck, Lynn ; Rejdak, Konrad ; Aralu, Cletus ; Djaldetti, Ruth ; Thomas, Karen ; Poewe, Werner ; Rizova, Yuliya ; Schwarz, Johannes ; Bonuccelli, Ubaldo ; Truong, Daniel ; Pazdera, Ladislav ; Savitt, Joseph ; Flitman, Stephen ; Patel, Neepa ; Klos, Kevin ; Gasparoli, Elisabetta ; Leehey, Maureen ; Ellenbogen, Aaron L. ; Hauser, Robert A. ; Gil, Ramon ; Hassin-Baer, Sharon ; Durif, Franck ; Cutler, Barry ; Bhatia, Perminder ; Espay, Alberto J. ; Defebvre, Luc ; Arkadir, David ; LeWitt, Peter ; Ebersbach, Georg ; Gurevich, Tanya ; Isa, Arnaldo ; Krawczyk, Malgorzata ; Sasson, Nissim ; Milo, Ron ; Kassubek, Jan-Rainer ; Biton, Victor ; Safirstein, Beth ; Klepitskaya, Olga ; Ginsberg, Paul ; Onofrj, Marco ; Yahalom, Gilad ; Danaila, Teodor

INTRODUCTION:

ND0612 is being investigated as a continuous, subcutaneous levodopa/carbidopa infusion, in combination with oral levodopa/carbidopa, for motor fluctuations in Parkinson's disease (PD). One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement in daily Good ON-time through 12 months of treatment.

METHODS:

We describe 3-year safety and efficacy outcomes for participants who completed 12 months of ND0612 treatment in the core study period and entered the extension phase.

RESULTS:

Of the 214 enrolled participants, 120 completed the core 1-year period, and 114 participants continued into the extension phase. Of these, 95/114 (83.3 %) completed 2 years and 77/114 (67.5 %) completed 3 years of study treatment. Key reasons for discontinuation were treatment-emergent adverse events (TEAEs) (n = 5 and n = 11 after 2 and 3 years, respectively) and withdrawal of consent (n = 9 and n = 5, respectively). TEAEs were reported by 105/114 (92.1 %) participants in Year 1, 77/114 (67.5 %) in Year 2, and 73/95 (76.8 %) in Year 3. While most participants experienced infusion site reactions, these led to discontinuation in only five participants during this extension. At Month 36, the mean reduction in OFF-time from baseline was 2.81 h and the increase in Good ON-time was 2.79 h.

CONCLUSIONS:

Three-year results from this open-label study support the long-term safety, tolerability, and efficacy of ND0612. For participants who entered the extension phase, the high rate of retention supports a favorable benefit-risk ratio of the ND0612 regimen for patients with PD experiencing motor fluctuations.

01 Mar 2025·BRAIN BEHAVIOR AND IMMUNITY

Sustained effects of repeated levodopa (L-DOPA) administration on reward circuitry, effort-based motivation, and anhedonia in depressed patients with higher inflammation

Article

Author: Lucido, Michael J ; Wommack, Evanthia C ; Li, Zhihao ; Dunlop, Boadie W ; Felger, Jennifer C ; Miller, Andrew H ; Bekhbat, Mandakh ; Revill, Kate P ; Haroon, Ebrahim ; Treadway, Michael T ; Mehta, Neeti D ; Ashchi, Andrea ; Goldsmith, David R ; Hong, Changdo

Inflammatory biomarkers like C-reactive protein (CRP) are elevated in a subset of patients with depression and have been associated with lower functional connectivity (FC) in a ventral striatum (VS) to ventromedial prefrontal cortex (vmPFC) reward circuit and symptoms of anhedonia. Evidence linking these relationships to the effects of inflammation on dopamine is consistent with our recent findings that acute levodopa (L-DOPA) increased VS-vmPFC FC in association with deceased anhedonia in depressed patients with higher but not lower CRP (>2 versus ≤ 2 mg/L). To determine whether repeated L-DOPA administration caused sustained effects on FC and behavior in these patients, medically stable depressed outpatients with CRP > 2 mg/L and anhedonia (n = 18) received one week of three doses of L-DOPA (150-450 mg/day/week with carbidopa) or placebo in a randomized order. Resting-state (rs) and task-based (tb; monetary incentive delay) fMRI, effort-based motivation, and exploratory measures of anhedonia and depression severity were assessed at baseline and after one week of placebo and each dose of L-DOPA. Responses to individual doses of L-DOPA varied across outcomes. For example, VS-vmPFC rs-FC was significantly increased by L-DOPA at 150 and 450 mg/day/week (p < 0.01), whereby approximately half of patients responded optimally to 150 mg/day L-DOPA and approximately half required higher doses for maximum effect. While effort-based motivation was only significantly increased by L-DOPA at 150 mg/day (p < 0.05), it correlated with VS-vmPFC rs-FC at this dose (r = 0.64, p = 0.024), and all L-DOPA doses met a clinically significant threshold of ≥ 10 % increase versus placebo. When comparing the maximum response at any L-DOPA dose to placebo, high effect sizes were observed for these primary outcomes and tb-FC during reward anticipation (d_z = 0.82-0.98, p < 0.01), as well as secondary and exploratory measures of anhedonia and depression severity (d_z = 0.48-0.97, p < 0.05). Sustained effects on reward circuitry, effort-based motivation, and anhedonia by repeated L-DOPA administration support the therapeutic potential of agents that increase dopamine in depressed patients with higher inflammation.

164

News (Medical) associated with Carbidopa

06 Feb 2025

·www.pharmaceutical-technology.com

Supernus wins FDA approval for Parkinson’s pump on fourth try

Onapgo is approved for adult Parkinson’s patients experiencing motor fluctuations. Credit: Inside Creative House via Getty Images. Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson’s disease. Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval. The company acquired Onapgo, previously known as SPN-830, from US WorldMeds in 2020. Soon after, Supernus submitted its first application for FDA review. However, in 2020, the agency issued a refusal-to-file (RTF) letter, determining that the submission was incomplete and not ready for formal review. Supernus resubmitted the application twice, receiving complete response letters (CRLs) both times. The first 2022 rejection required further analysis of the infusion device and drug product, while the most recent CRL, issued in April 2023, cited product quality concerns and deficiencies in the master file for the proprietary pump. The company resubmitted its fourth application in August, leading to the current approval. Onapgo will now be available for adult Parkinson’s disease patients experiencing motor fluctuations. The wearable pump is designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is intended for patients experiencing “off” periods, where medication wears off and symptoms return or worsen. The approval is based on a Phase III, 12-week study (NCT02006121) involving 107 patients. Onapgo led to a drop in daily “off” time and an increase in daily good “on” time, defined as periods without dyskinesia and the patient’s global impression of change (PGIC). Supernus plans to launch Onapgo in the second quarter of 2025, supported by a team of specialists, a nurse education programme, and access support services. The approval adds Onapgo to a growing list of infusion-based Parkinson’s treatments. AbbVie ’s Vyalev (foscarbidopa and foslevodopa), a continuous subcutaneous infusion therapy combining prodrugs of carbidopa and levodopa, was approved in October 2024 after three regulatory attempts. The FDA’s initial rejection of Vyalev did not involve efficacy or safety concerns but requested additional information on the pump device. The second rejection followed findings of issues at a third-party manufacturer. AbbVie set a precedent in 2015 with its Parkinson’s disease infusion pump therapy Produodopa (foslevodopa foscarbidopa), sparking innovation in drug delivery systems as companies looked for alternatives for conventional oral treatments.

Drug ApprovalPhase 3

04 Dec 2024

·www.prnewswire.com

Mitsubishi Tanabe Pharma America to Present Data on Investigational ND0612 at the 2024 Annual Meeting of the Parkinson Study Group

JERSEY CITY, N.J., Dec. 4, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of two abstracts on investigational ND0612 in Parkinson's disease (PD) at the 2024 Annual Meeting of the Parkinson Study Group (PSG), being held December 5-8 in Nashville, Tenn. ND0612 is being evaluated as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). "We look forward to attending the PSG meeting where we will discuss our latest findings on investigational ND0612 with other experts from the scientific community," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "This ongoing research is driven by our passion to support the Parkinson's disease community and continue investigating areas of significant unmet needs for patients." MTPA's posters will be presented in Grand Hall A, B & C on December 5, 5:00 p.m.-7:00 p.m. CST: Presentation Details: Presentations will discuss outcomes from the open-label, Phase 2b BeyoND study (NCT02726386), which evaluated the safety and efficacy of investigational ND0612 over three years in people with PD experiencing motor fluctuations, as well as a characterization of infusion site reactions (ISRs) reported from treatment with ND0612 in clinical studies. Continuous Subcutaneous Levodopa/Carbidopa Infusion with ND0612 for Parkinson's Disease: Three-Year Data from the Open-Label BeyoND Study (Jonathan Pereira, M.D.; MTPA) Characterization of Infusion Site Reactions (ISRs) with 24-Hour Subcutaneous Infusion of ND0612: Findings from an Integrated Safety Database (Jonathan Pereira, M.D.; MTPA) About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at or follow the Company on LinkedIn. Media inquiries: [email protected] SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

21 Nov 2024

·www.globenewswire.com

TrueBinding Receives FDA IND Go Ahead for Parkinson’s Phase 2A Clinical Trial

Nov. 18, 2024 -- TrueBinding, Inc., a clinical-stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases and other serious diseases, has cleared an FDA Investigational New Drug (IND) application for the Biologic IgG4 antibody neutralizing Galectin-3, TB006, for potential disease modification of Parkinson’s Disease. “FDA IND approval for TB006 is a major achievement for TrueBinding and a significant potential advancement for the treatment of Parkinson’s Disease worldwide,” said Alan K. Jacobs, M.D., FAAN, Chief Medical Officer of TrueBinding. “This first-in-class therapy harnesses the power of antibody selectivity to target the protein, Galectin-3, offering a promising new option for patients with no available disease-modifying treatment options.” TB006 is a therapy that is delivered via monthly intravenous infusion and is designed to target and neutralize Galectin-3, possibly enabling the dissociation of neurotoxic oligomers including alpha-synuclein, reducing the activation of pro-inflammatory microglia and the release of associated cytokines, and providing reparative impact upon intracellular lysosomes. The approval of the IND application for the therapy will initiate the launch of Parkinson’s clinical trials in the U.S. A multi-center, placebo-controlled, Phase 2A trial (NCT) of TB006 in the U.S. will be evaluating the safety and efficacy of this treatment in patients with early to mild Parkinson’s Disease. The trial will enroll adults aged 50 to 80 years of age who have confirmed Hoehn and Yahr grade 1 or 2 Parkinson’s Disease, less than five (5) years since diagnosis, and currently on no other Parkinson’s Disease medications or only immediate-release Levodopa-containing therapy. The estimated enrollment for the trial is 62 patients, and the estimated primary completion date is Q1 2026. Parkinson’s disease (PD) is a chronic and progressive neurodegenerative disorder that affects dopamine-producing cells. About 70% of people with PD experience tremor. PD symptoms often vary throughout the day, worsening with anxiety, fatigue or as medication wears off in between doses. Regular exercise can help manage PD symptoms and improve quality of life. Carbidopa/levodopa (brand name Sinemet) is still the “gold standard” in PD medications. It is common for people with PD to need adjustments to treatment as symptoms progress. Parkinson’s disease is a disorder that causes a gradual loss of cells that produce dopamine, a chemical necessary for cell-to-cell neurotransmission. As dopamine decreases over time, movement and non-motor functionality become more difficult for people with PD. Dopamine also affects mood and motivation. In addition to dopamine, Parkinson’s changes several other brain chemicals. Nearly one million people in the U.S. and 10 million people worldwide are living with PD. About 90,000 Americans are diagnosed with Parkinson’s each year. It is the second most common neurodegenerative condition after Alzheimer’s. The number of people with PD will increase substantially in the next 20 years due to our aging population. The most visible and well-known signs of PD are movement (or motor) symptoms) such as tremor, slow movement, stiffness and balance issues. However, most people also develop non-movement (or non-motor) symptoms that impact mood and quality of life. These can include anxiety, sleep issues and thinking changes. Initial symptoms can be mild and sometimes mistaken for signs of aging. Parkinson’s is a complex disease that affects everyone differently. For most people with PD, symptoms develop gradually over many years and worsen over time. Parkinson’s is typically diagnosed after 60, but people under 50 can also have PD. This is known as young-onset Parkinson’s disease (YOPD). About 4% of people with Parkinson’s have YOPD. Men are 1.5 times more likely to have Parkinson’s than women, and certain geographic areas and ethnic groups experience higher rates of PD. Researchers believe that Parkinson’s is caused by a combination of genetic, environmental and other factors. About 10 to 15% of people with PD have a genetic link. There is no single test for Parkinson’s. A doctor makes a diagnosis based on a person’s symptoms, medical history and a physical examination. Sometimes conditions that look like PD can be ruled out by additional lab tests and imaging. To consider a diagnosis of Parkinson’s disease, a person must have bradykinesia (slow movement) in addition to one or more of the following: Shaking or tremor in a limb that occurs while it is at rest Stiffness or rigidity of the arms, legs, or trunk Trouble with balance and falls A PD diagnosis can take time. When symptoms first appear, many people choose to speak to their family doctor, who may provide a referral to a neurologist if Parkinson’s is suspected. Some neurologists, called movement disorder specialists, have additional training in diagnosing and treating PD and other movement disorders. Though Parkinson’s varies from person to person, most people with PD need to take medications that boost, mimic or replace dopamine to manage their symptoms. Studies show that regular exercise also can benefit movement and non-movement symptoms and can improve overall quality of life. For some people, surgical intervention may be an option. People with PD can experience a wide range of complex symptoms, so building a team of healthcare professionals is key. This team may include physical, occupational and speech therapists as well as other specialists, including mental health professionals, a urologist or gastrointestinal doctor. TB006 is a humanized monoclonal antibody that, based on preclinical data and advancing clinical studies, has the potential to improve cognition and functioning of patients with Alzheimer’s Disease and Parkinson’s Disease. In pre-clinical evaluations, Galectin-3 was shown to intrinsically promote the aggregation of Aβ and pTau proteins. In Alzheimer’s Disease in vivo model studies, TB006, showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance, which show potential therapeutic effect of TB006 in addressing underlying pathology and ameliorating the course of Alzheimer’s Disease. In a Phase 1b/2 proof-of-concept trial in mild to severe Alzheimer’s patients, TB006, demonstrated a positive trend toward improvements in cognition and functioning. TB006 has also been evaluated in a Phase 2 open-label extension trial in patients with Alzheimer’s Disease and has been allowed by the FDA for conditional use through an Expanded Access Program. Clinical trials demonstrated that TB006 was well tolerated with a favorable safety profile. TrueBinding, Inc. is a clinical stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases including Alzheimer’s Disease and Parkinson’s Disease. The Company is focused on rapidly advancing its lead drug candidate, TB006, a humanized monoclonal antibody targeting Galectin-3. For more information, visit www.truebinding.com. 1 Reference is made to the Parkinson’s Foundation website, www.parkinsons.org The content above comes from the network. if any infringement, please contact us to modify.

INDClinical Result

100 Deals associated with Carbidopa

External Link

KEGG	Wiki	ATC	Drug Bank
D00558	Carbidopa	N04BA03	DB00190

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Nausea	US	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease	US	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease, Postencephalitic	US	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease, Secondary	US	Aton Pharma, Inc.	25 Apr 1977
Vomiting	US	Aton Pharma, Inc.	25 Apr 1977

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02553265 (CarbiFD, CTgov)	Phase 2	Pure Autonomic Failure \| Dysautonomia, Familial	22	Placebo (Placebo)	oafiqgocjz(ertoxfwelo) = olpnvndzzb xosihnuaeq (iwkztqpnqt, qfbnpgifxx - suuwrfqsvk) View more	-	09 Feb 2022
				Carbidopa Low-Dose (Low-Dose Carbidopa)	oafiqgocjz(ertoxfwelo) = fikasfogif xosihnuaeq (iwkztqpnqt, pwkqukomme - jgayoeener) View more
NCT00685919 (CTgov)	Phase 2/3	Postural Orthostatic Tachycardia Syndrome	32	Placebo (Healthy Participants Who Received Placebo as Treatment A or Treatment B)	vimgnmrknd(kbygdmbpjs) = vprtjnmstx oqjamlrtnb (rvqvrrgezo, rwjqgeuloi - pvzdgylvwe) View more	-	20 Sep 2021
				Carbidopa (Healthy Participants Who Received Carbidopa as Treatment A or Treatment B)	vimgnmrknd(kbygdmbpjs) = shaifycdtr oqjamlrtnb (rvqvrrgezo, hdxatxttzb - kdbhsldkyo) View more
EANM2020	Not Applicable	Brain Cancer 18 F-FDOPA	-	Carbidopa premedication	agumfeygdl(gziglgqbcz) = djsqvkzuww ohgutztdze (hcjzjmgxdp ) View more	-	18 Sep 2020
				Carbidopa (No premedication)	agumfeygdl(gziglgqbcz) = bmrzeeludt ohgutztdze (hcjzjmgxdp ) View more
AAN2020	Not Applicable	Parkinson Disease	23	CVT-301 84mg with CD 25mg	ccmqsiyfkf(oziitezfdy) = 7 (30.4%) in the CVT-301 group vs 1 (4.5%) subject administered oral CD/LD ybtinvvavm (sudigicvxt )	Positive	14 Apr 2020
				Oral CD/LD 25/100mg
NCT03115827 (CTgov)	Phase 4	Parkinson Disease	15	Carbidopa+Droxidopa	igrbqtewbt(tmgtcjfjur) = dshjvwkpia bvmkcyhtvf (hpujnxphpg, ihewzdeyeb - hrfjfackyb) View more	-	27 Jan 2020
NCT01766258 (Pubmed \| Neurology)	Phase 2	Parkinson Disease COMT genotypes Val/Met	-	ODM-101/65	kbirpcmape(xbnuzwbacg) = Treatment-related serious adverse events were blood creatine kinase increase (LCE) qgrrjgfnwi (yxayttetzr ) View more	-	26 Mar 2019
				ODM-101/105
MDS2018	Not Applicable	Hyperhomocysteinemia INR \| D-dimer \| homocysteine	-	Levodopa/carbidopa intestinal gel (LCIG)	rvyrkeocyl(kfojqukskp) = ewqigkqlex kivfzwkplu (lsgizmbgth ) View more	-	05 Oct 2018
EAN2018	Not Applicable	Parkinson Disease	68	infusion-based therapies (Subthalamic deep brain stimulation (STN-DBS))	ggnhauffeq(nkycablhpr) = caoovocdcx bofwabboey (xaeyclzqwt, 788)	Negative	14 Jun 2018
				Subcutaneous apomorphine infusion (Apo)	ggnhauffeq(nkycablhpr) = pkjuxyfcxe bofwabboey (xaeyclzqwt, 579)

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