Expanded Access With Trappsol(R) Cyclo(TM) for an Individual Patient With Late Onset Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
To afford urgent access to a potential-disease modifying treatment, Dr. Diana Kerwin, in partnership with CTD Holdings, the manufacturer of Trappsol (R) Cyclo(TM), will administer the product to a patient with Alzheimer's Disease who has no other disease-modifying treatment options.
详细描述
Trappsol(R) Cyclo(TM) will be administered via intravenous (IV) infusion. The initial dose will be 500 mg/kg (T=Day 0). Subsequent dosing is anticipated to increase over 9 months, with all subsequent doses given monthly at the maximum dose determined by tolerability, lack of toxicity or adverse event, pharmacokinetic analysis and patient preference. So long as the overall risk/benefit profile favors continued dosing, the patient will continue to receive Trappsol (R) Cyclo (TM) for a minimum of 12 months, if not perpetually.
Risk/benefit assessments will include:
- Vital signs, ECG and laboratory parameters (CBC, chemistry panel, hematology, urinalysis, lipids, coagulation)
- Brain MRI without gadolinium for safety monitoring
- Amyloid and Tau PET (positron emission tomorgraphy) imaging
- Adverse Events
- Mini-mental status score
- Digital Cognition Technologies (DCT) Clock
- Changes in blood biomarkers
- Pharmacokinetic data
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Alzheimer's Disease who continued to decline neurologically and had no other treatment options with intent to halt progression available. All other medical conditions stable & well-managed.
排除标准
- 未提供