A Randomized, Placebo-controlled, Double-blind, Parallel-group, 6-Month Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Monthly Trappsol® Cyclo™ Infusions in Patients With Early Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Safety assessments to include incidence of Adverse Events and Serious Adverse Events
研究概览
简要总结
Approximately 90 patients, aged 50 to 80 years, with a diagnosis of early Alzheimer's disease will take part in this research study. This study will be conducted in the US. There will be 3 treatment groups: 2 Active doses and 1 group will receive placebo completely by chance. Patients, caregiver, Sponsor, nor study staff will know which treatment is assigned. There are 3 periods in this study: Screening to confirm suitability, Treatment to receive study medication, and Follow-up to check overall health post-participation
详细描述
This is a randomized, placebo-controlled, double-blind, parallel-group study that will assess the safety, tolerability, and potential efficacy of Trappsol Cyclo in patients with EAD as defined according to the FDA Guidance for Industry on Early Alzheimer's Disease: Developing Drugs for Treatment. The study will enroll approximately 90 (30 patients/treatment arm) male and female patients aged 50 to 80 years at Screening with characteristic pathophysiologic changes of AD who meet National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for either AD with MCI or mild AD collectively known as EAD (Stages 3 and 4). Enrolled patients must have evidence of progressive cognitive decline in the last year as determined by serial cognitive test scores, if available, or patient or informant/caregiver/study partner (hereafter called caregiver) report as documented by the Investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MCI due to AD (Stage 3)
- •MMSE-2:SV score 20 and 28 at both Screening (V1) and Baseline (V2) with no more than a 3 point change between visits
- •Positive PrecivityAD blood test biomarker for AD with high APS (58-100) Locally or centrally read MRI of ARIA
排除标准
- •Clinically significant renal disease
- •Evidence of a neurodegenerative disease other than AD Severe hypothyroidism
- •Abnormally low levels of serum Vitamin B12
- •Lacks visual, auditory acuity and/or language abilities adequate to perform cognitive assessments
研究组 & 干预措施
Experimental
Intravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks
干预措施: Hydroxypropyl Beta Cyclodextrin (Drug)
Placebo
Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessments to include incidence of Adverse Events and Serious Adverse Events
时间窗: up to 24 weeks
Incidence of AEs, SAEs, incidence of abnormal laboratory test results, abnormal ECGs, abnormal physical exams, abnormal vital signs and abnormal hearing assessments assessments
次要结局
- Change in ADCS-CGIC from Baseline(Weeks 12 and 24)
- Change in ADCS-ADL from Baseline(Weeks 12 and 24)
- Mean change in total ADAS-Cog-14 score from Baseline(Week 12 and 24)
- Change in CDR-SB from Baseline(Weeks 12 and 24)
- Change in MMSE-2:SV total score from Baseline(Weeks 12 and 24)