Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Percentage of change in care practices after amyloid PET scan
研究概览
简要总结
The main purpose of this study is to build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of PET Amyloid Classification Technology (IMPACT; NCT number not yet assigned) trial design.
详细描述
The primary purpose of this prospective, observational study is to examine the benefit of amyloid positron emission tomography and computed tomography (PET/CT) scan in clinical practice for participants at our site that are enrolled in the IDEAS (NCT02420756) trial. To accomplish this, when a clinician has ordered an amyloid PET scan, the investigators will assess the impact of [18F]Flutemetamol PET/CT scans on 1) physician diagnosis and management as it relates to care practices and drug management, and 2) patient reported outcomes in patients evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for clinical amyloid PET/CT scans. A secondary purpose is to compare the semi-quantitative assessment of amyloid plaque burden using vendor supplied software and standard visual assessment of amyloid positivity.
The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.
Objectives
AIM 1: to assess the change in diagnosis and management, related to care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC)
AIM 2: to assess the change of amyloid PET/ CT scans on patient-reported outcomes involving care partner confidence and satisfaction
研究设计
- 研究类型
- 观察性
- 观察模型
- 仅病例
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 65 and older;
- Medicare beneficiary;
- Diagnosis of mild cognitive impairment (MCI) or dementia, according to Diagnostic and Statistical Manual - IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Meets AUC:
- Cognitive complaint verified by objectively confirmed cognitive impairment;
- The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging as below;
- Alzheimer's disease is a diagnostic consideration;
- Knowledge of amyloid PET status is expected to alter diagnosis and management.
- Head MRI and/or CT within 24 months prior to enrollment;
- Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH); vitamin B12;
- Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
- English or Spanish speaking (for the purposes of informed consent);
- Willing and able to provide consent. Consent may be by proxy.
排除标准
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers.
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Hip/pelvic fracture within the 12 months prior to enrollment;
- Body weight exceeds PET scanner weight limit;
- Life expectancy less than 24 months based on medical co-morbidities;
- Residence in a skilled nursing facility.
结局指标
主要结局
Percentage of change in care practices after amyloid PET scan
时间窗: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
% of 13 care practices that differ before and after the amyloid PET scan
次要结局
- Percentage of change in drug management options after amyloid PET(Visit 1, 30 days prior to scan and Visit 4, 90 days after scan)
- Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan(Visit 1, 30 days prior to scan and Visit 4, 90 days after scan)
- Percentage of change in leading diagnosis after amyloid PET(Visit 1, 30 days prior to scan and Visit 4, 90 days after scan)
- Change in physician confidence in leading diagnosis(Visit 1, 30 days prior to scan and Visit 4, 90 days after scan)
- Change in care partner's confidence in diagnosis after amyloid PET(Visit 1, 30 days prior to scan, Visit 4, 90 days after scan, Visit 5, 180 days after scan and Visit 6, 270 days after scan)
- Change in care partner satisfaction with evaluation after amyloid PET(Visit 1, 30 days prior to scan and Visit 4, 90 days after scan)
- Change in care partner assessment of the quality of evaluation after amyloid PET(Visit 1, 30 days prior to scan and Visit 4, 90 days after scan)
- Proportion of care partners finding amyloid PET scan worthwhile(Visit 4, 90 days after scan)
- Proportion exhibiting increased behavior disturbance during amyloid scan visit(Visit 1, Visit 2, Visit 3, and Visit 4 90 days post scan)
- Percentage of change exhibiting increased behavior disturbance when the diagnosis is given(Visit 1, Visit 3, 60 days)
- Care partner's sustained confidence in diagnosis received after amyloid PET scan(Visit 4, Visit 5, and Visit 6, 270 days post scan)
- Care partner's sustained confidence in ability to adhere to management plan received after amyloid PET scan(Visit 4, Visit 5, and Visit 6, 270 days post scan)
- Percentage of recommended care practices adhered to after amyloid PET scan(Visit 4, Visit 5, and Visit 6, 270 days post scan)
- Percentage of recommended drug management adhered to after amyloid PET scan(Visit 4, Visit 5, and Visit 6, 270 days post scan)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT02781220
- 其他研究编号
- 90351
日期
- 首次提交
- (10年前)
- 首次发布
- (10年前)
- 主要完成日期
- (3年前)
- 研究完成日期
- (3年前)
- 最近核实
- 最近更新
- (去年)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
only de-identified data will be shared