A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) PET Scan Status and Cognitive Decline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 641
- 试验地点
- 1
- 主要终点
- Change in ADAS-Cog 11 Total Score
研究概览
简要总结
This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be enrolled in the mild impairment (not demented) group if the following criteria are met:
- •Males or females ≥ 50 to <= 90 years of age.
- •Have cognitive decline verified by a study partner or cognitive impairment verified by the study physician.
- •Have a study partner who provides separate consent and is willing to accompany the patient on all of the study visits.
- •Have an MMSE score of 24 to 30 inclusive.
- •Can tolerate a 10-minute PET scan.
- •Have the ability to cooperate and comply with all study procedures.
- •Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment.
- •Ability to provide informed consent for study procedures.
- •Patients may be enrolled in the dementia group if the following criteria are met:
- •Are males or females ≥ 50 to <= 90 years of age.
- •Meet clinical criteria for dementia.
- •Have a caregiver who provides separate consent and is willing to accompany the patient on all of the study visits.
- •Have an MMSE score of 16 to 24 inclusive.
- •Have not received a clinical examination and/or laboratory test results that strongly indicates a non-neurodegenerative cause for the patients cognitive impairment.
- •Can tolerate a 10-minute PET scan.
- •Have the ability to cooperate and comply with all study procedures.
- •Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment.
- •Ability to provide informed consent for study procedures. (If the patient is incapable of giving informed consent, the patient's legal representative may consent on behalf of the patient but the patient must still confirm assent. This person may serve as the study partner as well).
排除标准
- •Patients will be excluded from enrollment if they:
- •Have a current serious or unstable illness;
- •The patient or enrolling physician knows the result of a previous amyloid imaging scan;
- •The patient has a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
- •Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- •Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ -secretase or β -secretase inhibitor) unless it can be documented that the patient received only placebo during the course of the trial;
- •Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
- •Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
- •Patients will also be excluded from enrollment if their enrolling physician:
- •Does not consider Alzheimer's disease as a potential cause of the patient's cognitive decline.
- •Is not the primary physician taking care of the patient with respect to the management of their cognitive impairment.
- •Cannot categorize the patient as either: a) having a documented and completed evaluation for cognitive decline within the past 18 months old; or b) currently undergoing evaluation for cognitive decline.
- •Is unwilling to suspend all testing and other evaluation procedures between the time of the baseline evaluation of the enrolling physician's diagnosis and management plan and the time the completion of the PET scan.
研究组 & 干预措施
Control
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
干预措施: florbetapir (18F) (Drug)
Intervention
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
干预措施: florbetapir (18F) (Drug)
结局指标
主要结局
Change in ADAS-Cog 11 Total Score
时间窗: Baseline and 12 months
Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.
Clinical and Diagnostic Change in Patient Management
时间窗: Baseline and 3 months
Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).
次要结局
- Change in Patient Management: Advice/Counseling(Baseline and 3 months)
- Change in Patient Management: Individual Categories(Baseline and 3 months)
- Change in Diagnostic Confidence(Baseline and 3 months)
- Change in Caregiver Self-efficacy(Baseline and 3 months)
- Change in Patient's Clinical Diagnosis(Baseline and 3 months)