Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 317
- 试验地点
- 75
- 主要终点
- Patient Registry Participation
研究概览
简要总结
This registry will be used to identify patients who have etiology diagnosed or suspected to be Alzheimer's disease and positive amyloid scans, and have indicated their interest in being contacted for an Eli Lilly and Company (Lilly) Alzheimer's Disease drug research trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 50 years of age at the time of consent;
- •Patients who have objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer's disease;
- •Patients who are willing to make available to Avid a positive amyloid scan, or if an amyloid scan is not available, are willing to undergo amyloid scanning via the Florbetapir F 18 PET Scan Addendum;
- •Patients who are willing to be contacted for possible participation in Lilly drug research trials targeting Alzheimer's disease;
- •Patients who give informed consent or have a legally authorized representative (LAR) to consent for enrollment; and
- •Patients who have a partner (informant) who is willing to participate as a source of information and has at least weekly contact with the patient (contact can be inperson, via telephone or electronic communication). The informant must have sufficient contact such that the referring physician feels the informant can provide meaningful information about the patient.
排除标准
- •Patients who have a Mini Mental State Examination (MMSE) score of < 16;
- •Patients who have an amyloid-negative PET scan (either a historical scan or scan via the Florbetapir F 18 PET Scan Addendum);
- •Patients who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the registry, or would be likely to preclude participation in a drug research trial;
- •Patients who are currently participating in a clinical trial with an investigational agent; or
- •Patients who, in the opinion of the physician, are otherwise unsuitable for this registry.
研究组 & 干预措施
RAmP Registry Patients
Patients who have a) objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer's disease and b) a positive amyloid scan from either an existing amyloid scan that has been interpreted as positive or a florbetapir F 18 PET scan via protocol addendum
干预措施: florbetapir F 18 PET scan (Drug)
结局指标
主要结局
Patient Registry Participation
时间窗: Two years
There is no formal hypothesis to test in this registry study. The registry will collect contact information of amyloid positive patients with cognitive impairment who have indicated interest in being contacted for a Lilly AD drug research trial. The primary outcome measure to be reported is the total number of participants in the registry.
次要结局
未报告次要终点