TB006在阿尔茨海默病及相关痴呆成人患者中的先行用药计划
1. 药物与机制简介
TB006 是一款用于治疗阿尔茨海默病/老年痴呆的在研实验药物，在 IIa 期临床试验中已显示出良好的安全性和初步疗效。基于这些积极结果，该药物已被批准纳入"扩大先行用药"（Expanded Access Program, EAP）计划，以满足部分重症患者的紧迫治疗需求。2023 年，TrueBinding 公司研发的 TB006 获美国 FDA 批准，启动中等规模患者的扩大使用项目——这是当年唯一获批的同类项目。该计划已于 2024 年和 2025 年持续获批延期，旨在为符合条件、缺乏其他有效治疗手段的阿尔茨海默病患者提供这一前景可期的研究性疗法。
TB006通过靶向半乳糖凝集素-3（Gal3）蛋白，提供了一种潜在的全新抗炎治疗途径。其作用机制针对疾病进展的双重路径：
- 抑制有害脑部聚集物：Gal3促进毒性寡聚体及斑块（如β淀粉样蛋白斑块和Tau蛋白缠结）的形成，破坏神经元通讯，导致认知功能下降。
- 调控神经炎症：Gal3过度活化会引发小胶质细胞异常激活及慢性神经炎症，进一步加剧神经元损伤。
通过选择性阻断Gal3，TB006可同时干预上述两条病理通路，不仅阻止有害脑部聚集物的形成，还能减轻神经炎症，有望部分逆转神经损伤并恢复认知功能。
本项目旨在为缺乏有效治疗、无法或不符合参与临床试验条件的患者提供TB006治疗。除不良事件（AEs）及严重不良事件（SAEs）外，不要求收集其他临床数据。
- 给药方案：患者每28天（±5天）接受一次TB006静脉输注，剂量为4000毫克，输注时间约1小时。
- 治疗周期：只要研究医生与患者共同认定获益大于风险，且项目申办方未终止研究、未停止TB006研发，或该药物未在患者所在国家/地区获批上市，治疗将持续进行。
- 安全监测：为保障患者安全，将实施以下评估：临床生化、血液分析、血液的淀粉样蛋白和Tau蛋白监测，生命体征、心电图、脑部磁共振成像, MMSE评分、体格检查，以及不良事件和严重不良事件记录。所有评估结果将归档于患者病历，申办方仅收集不良事件及严重不良事件数据。
主要资格标准：
- 经诊断患有轻度，中度 和中重度的 阿尔茨海默病，且其他健康状况控制良好且稳定都患者
- 因不耐受、存在禁忌症或疗效不佳而无法接受其他阿尔茨海默病药物治疗；
- 无法或不符合参与任何阿尔茨海默病临床试验的条件。
- LGAL3 SNP 基因检测，血常规， 血生化， 肝肾功能及心电图符合要求
参与人数：本项目为开放计划，不设人数上限。
- 统计考量：将对所有接受至少一次TB006给药的患者进行安全性分析。不良事件将采用最新版《监管活动医学词典》（MedDRA）编码，并按系统器官分类和首选术语统计发生率，同时依据严重程度、与治疗的相关性及导致停药的情况进行分类汇总。无预设统计分析计划。
- 数据监测：未设立专门的数据监测委员会。
1. TB006是否有正在进行的临床试验？
TrueBinding公司已完成TB006治疗阿尔茨海默病的Ib/II期临床试验及开放标签扩展试验（OLE）的患者招募。在下一阶段试验启动前，目前暂无正在招募受试者的TB006临床试验。因此，本扩大使用计划旨在为患者持续提供这一突破性药物的治疗机会。
2. 什么是扩大先行使用计划？
扩大先行使用（也称同情用药）是一项允许患有严重或危及生命疾病的患者在临床试验之外获取研究性药物的计划。该计划适用于缺乏已批准治疗选择，或因各种原因无法参与临床试验的患者，为其提供使用尚未获FDA最终批准的药物途径。本项目本着人道主义精神，为已竭尽常规治疗选择的患者带来新的希望。
3. 参与这个项目需要付费吗？
目前参与TB006扩展先行使用计划需承担相关费用。由于TB006的研发及生产成本高昂，除药物本身费用外，您还需承担以下开支：医师诊疗费、用于监测治疗进展的实验室检测及其他评估项目中的自付部分。作为该计划的患者，您需要自行承担药物费用以及保险公司不予覆盖的检查、治疗及相关医疗支出。
王东医生是大亚特兰大地区唯一经审核批准、可提供TB006同情用药治疗的神经内科医生。其诊所可为符合资格的阿尔茨海默病患者提供TB006静脉输注治疗。
地址：3859 Postal Drive, Suite 100, Duluth, GA 30095
预约咨询专线：678-878-2989
Protocol ID: TB006 Expanded Access (Compassionate Use)
Version Date: May 30, 2023, v1
Developer: TrueBinding Inc.
TB006 is an investigational drug for the treatment of Alzheimer's disease. It has demonstrated significant efficacy and a favorable safety profile in Phase II-a clinical trials, leading to its approval for compassionate use.
TrueBinding's TB006 received U.S. FDA approval in 2023 under an Intermediate-Size Patient Protocol for an Expanded Access Program—the only such program approved that year. The program was renewed in 2024 and 2025, allowing eligible patients with serious or life-threatening conditions to access this promising investigational therapy when no comparable treatment alternatives exist.
TB006 targets Galectin-3 (Gal3), a protein implicated in the progression of Alzheimer's disease, offering a novel anti-inflammatory therapeutic approach. Its dual mechanism of action addresses two key pathological pathways:
- Reduction of Harmful Brain Aggregates: Gal3 promotes the formation of toxic oligomers and plaques, such as amyloid-beta (Aβ) plaques and tau neurofibrillary tangles (NFTs), which disrupt neuronal communication and contribute to cognitive decline.
- Modulation of Neuroinflammation: Overactivation of Gal3 triggers abnormal microglial activation and chronic neuroinflammation, leading to further neuronal damage.
By selectively inhibiting Gal3, TB006 simultaneously targets both pathways—preventing the formation of harmful aggregates and mitigating neuroinflammation, with the potential to partially reverse neural damage and restore cognitive function.
This program aims to provide TB006 treatment for patients who lack effective therapeutic options and are unable to participate in or ineligible for clinical trials. Aside from the collection of adverse events (AEs) and serious adverse events (SAEs), no additional clinical data will be systematically recorded.
- Dosing Regimen: Patients will receive a 4,000 mg intravenous infusion of TB006 once every 28 days (±5 days), with each infusion lasting approximately one hour.
- Treatment Duration: Treatment may continue as long as the investigating physician and the patient agree that the benefits outweigh the risks, and until the sponsor terminates the program, discontinues TB006 development, or the drug becomes commercially available in the patient's country.
- Safety Monitoring: To ensure patient safety, the following assessments will be conducted: clinical biochemistry, blood p-Tau-217 and beta-amyloid 42/40 ratio, hematological analysis, vital signs, electrocardiogram (ECG), brain MRI, Mini-Mental State Examination (MMSE) scoring, physical examinations, and documentation of AEs and SAEs. All results will be recorded in the patient's medical record, and only AE/SAE data will be collected by the sponsor.
Key Eligibility Criteria:
- Diagnosed with symptomatic dementia, including but not limited to Alzheimer's disease accompanied by cognitive impairment, with other medical conditions being stable and well-managed.
- Unable to tolerate, having contraindications to, or showing inadequate response to other available Alzheimer's treatments.
- Unable to participate or ineligible for any ongoing Alzheimer's disease clinical trials.
- LGAL3 SNP genetic testing, complete blood count, blood biochemistry, liver and kidney function, and electrocardiogram results meet the requirements.
Participant Enrollment: This is an open-access program with no predefined enrollment limit.
- Statistical Analysis: Safety analyses will include all patients who receive at least one dose of TB006. Adverse events will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class and preferred term. Summaries will include severity, relationship to treatment, and events leading to discontinuation. No pre-specified statistical analysis plan is required.
- Data Monitoring: No independent data monitoring committee has been established for this program.
1. Are there any ongoing clinical trials for TB006?
TrueBinding has completed patient enrollment for the Phase Ib/II clinical trial and the open-label extension (OLE) study of TB006 for Alzheimer's disease. Currently, there are no actively recruiting clinical trials for TB006. This Expanded Access Program ensures continued patient access to this breakthrough therapy until the next trial phase begins.
2. What is an Expanded Access Program?
Expanded Access, also known as compassionate use, is a regulatory pathway that allows patients with serious or life-threatening conditions to access investigational drugs outside of clinical trials. It is intended for patients who have exhausted approved treatment options or are unable to participate in clinical trials, providing a humanitarian avenue to promising therapies not yet fully approved by the FDA.
3. Does participating in this program require payment?
Currently, participation in the TB006 Expanded Access Program requires bearing relevant costs. Due to the high research, development, and production expenses of TB006, in addition to the cost of the drug itself, you will also be responsible for the following expenses: physician consultation fees, as well as out-of-pocket portions of laboratory tests and other assessments required for monitoring treatment progress. As a patient enrolled in this program, you will need to cover the costs of the medication, along with examinations, treatments, and related medical expenses not covered by insurance.
Dr. Wang Dong is the only neurologist in the greater Atlanta area certified to administer TB006 under the Expanded Access program. His clinic provides TB006 intravenous infusion therapy for eligible demented patients.
Address: 3859 Postal Drive, Suite 100, Duluth, GA 30095
Consultation and Appointment Line: 678-878-2989
1. 药物与机制简介
TB006 是一款用于治疗阿尔茨海默病/老年痴呆的在研实验药物，在 IIa 期临床试验中已显示出良好的安全性和初步疗效。基于这些积极结果，该药物已被批准纳入"扩大先行用药"（Expanded Access Program, EAP）计划，以满足部分重症患者的紧迫治疗需求。2023 年，TrueBinding 公司研发的 TB006 获美国 FDA 批准，启动中等规模患者的扩大使用项目——这是当年唯一获批的同类项目。该计划已于 2024 年和 2025 年持续获批延期，旨在为符合条件、缺乏其他有效治疗手段的阿尔茨海默病患者提供这一前景可期的研究性疗法。
TB006通过靶向半乳糖凝集素-3（Gal3）蛋白，提供了一种潜在的全新抗炎治疗途径。其作用机制针对疾病进展的双重路径：
- 抑制有害脑部聚集物：Gal3促进毒性寡聚体及斑块（如β淀粉样蛋白斑块和Tau蛋白缠结）的形成，破坏神经元通讯，导致认知功能下降。
- 调控神经炎症：Gal3过度活化会引发小胶质细胞异常激活及慢性神经炎症，进一步加剧神经元损伤。
通过选择性阻断Gal3，TB006可同时干预上述两条病理通路，不仅阻止有害脑部聚集物的形成，还能减轻神经炎症，有望部分逆转神经损伤并恢复认知功能。
二、项目概述本项目旨在为缺乏有效治疗、无法或不符合参与临床试验条件的患者提供TB006治疗。除不良事件（AEs）及严重不良事件（SAEs）外，不要求收集其他临床数据。
三、治疗方案与安全监测- 给药方案：患者每28天（±5天）接受一次TB006静脉输注，剂量为4000毫克，输注时间约1小时。
- 治疗周期：只要研究医生与患者共同认定获益大于风险，且项目申办方未终止研究、未停止TB006研发，或该药物未在患者所在国家/地区获批上市，治疗将持续进行。
- 安全监测：为保障患者安全，将实施以下评估：临床生化、血液分析、血液的淀粉样蛋白和Tau蛋白监测，生命体征、心电图、脑部磁共振成像, MMSE评分、体格检查，以及不良事件和严重不良事件记录。所有评估结果将归档于患者病历，申办方仅收集不良事件及严重不良事件数据。
主要资格标准：
- 经诊断患有轻度，中度 和中重度的 阿尔茨海默病，且其他健康状况控制良好且稳定都患者
- 因不耐受、存在禁忌症或疗效不佳而无法接受其他阿尔茨海默病药物治疗；
- 无法或不符合参与任何阿尔茨海默病临床试验的条件。
- LGAL3 SNP 基因检测，血常规， 血生化， 肝肾功能及心电图符合要求
参与人数：本项目为开放计划，不设人数上限。
五、统计与监管- 统计考量：将对所有接受至少一次TB006给药的患者进行安全性分析。不良事件将采用最新版《监管活动医学词典》（MedDRA）编码，并按系统器官分类和首选术语统计发生率，同时依据严重程度、与治疗的相关性及导致停药的情况进行分类汇总。无预设统计分析计划。
- 数据监测：未设立专门的数据监测委员会。
1. TB006是否有正在进行的临床试验？
TrueBinding公司已完成TB006治疗阿尔茨海默病的Ib/II期临床试验及开放标签扩展试验（OLE）的患者招募。在下一阶段试验启动前，目前暂无正在招募受试者的TB006临床试验。因此，本扩大使用计划旨在为患者持续提供这一突破性药物的治疗机会。
2. 什么是扩大先行使用计划？
扩大先行使用（也称同情用药）是一项允许患有严重或危及生命疾病的患者在临床试验之外获取研究性药物的计划。该计划适用于缺乏已批准治疗选择，或因各种原因无法参与临床试验的患者，为其提供使用尚未获FDA最终批准的药物途径。本项目本着人道主义精神，为已竭尽常规治疗选择的患者带来新的希望。
3. 参与这个项目需要付费吗？
目前参与TB006扩展先行使用计划需承担相关费用。由于TB006的研发及生产成本高昂，除药物本身费用外，您还需承担以下开支：医师诊疗费、用于监测治疗进展的实验室检测及其他评估项目中的自付部分。作为该计划的患者，您需要自行承担药物费用以及保险公司不予覆盖的检查、治疗及相关医疗支出。
推荐阅读 联系我们王东医生是大亚特兰大地区唯一经审核批准、可提供TB006同情用药治疗的神经内科医生。其诊所可为符合资格的阿尔茨海默病患者提供TB006静脉输注治疗。
地址：3859 Postal Drive, Suite 100, Duluth, GA 30095
预约咨询专线：678-878-2989
Expanded Access Program for TB006 in Adults with Alzheimer's Disease
Protocol ID: TB006 Expanded Access (Compassionate Use)
Version Date: May 30, 2023, v1
Developer: TrueBinding Inc.
TB006 is an investigational drug for the treatment of Alzheimer's disease. It has demonstrated significant efficacy and a favorable safety profile in Phase II-a clinical trials, leading to its approval for compassionate use.
TrueBinding's TB006 received U.S. FDA approval in 2023 under an Intermediate-Size Patient Protocol for an Expanded Access Program—the only such program approved that year. The program was renewed in 2024 and 2025, allowing eligible patients with serious or life-threatening conditions to access this promising investigational therapy when no comparable treatment alternatives exist.
TB006 targets Galectin-3 (Gal3), a protein implicated in the progression of Alzheimer's disease, offering a novel anti-inflammatory therapeutic approach. Its dual mechanism of action addresses two key pathological pathways:
- Reduction of Harmful Brain Aggregates: Gal3 promotes the formation of toxic oligomers and plaques, such as amyloid-beta (Aβ) plaques and tau neurofibrillary tangles (NFTs), which disrupt neuronal communication and contribute to cognitive decline.
- Modulation of Neuroinflammation: Overactivation of Gal3 triggers abnormal microglial activation and chronic neuroinflammation, leading to further neuronal damage.
By selectively inhibiting Gal3, TB006 simultaneously targets both pathways—preventing the formation of harmful aggregates and mitigating neuroinflammation, with the potential to partially reverse neural damage and restore cognitive function.
Contact InformationDr. Wang Dong is the only neurologist in the greater Atlanta area certified to administer TB006 under the Expanded Access program.
Address: 3859 Postal Drive, Suite 100, Duluth, GA 30095
Phone: 678-878-2989
