Multicenter Study to Explore the Impact of Florbetaben (FBB) in Change of Diagnosis in Patients Who Are Evaluated for AD and in Whom Lumbar Puncture is Contraindicated or CSF Results Are Ambiguous
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
研究概览
简要总结
This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom:
- lumbar puncture was not feasible for medical conditions
- results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
- lumbar puncture (LP) was refused by the patient
详细描述
It will be conducted in an outpatient setting at the tertiary memory clinics (CMRR) in France in patients with a preliminary diagnosis based on the completion of a prior, full diagnostic workup, not more than 12 months previously - which could include, but will not be limited to brain imaging if needed (magnetic resonance imaging (MRI) or computed tomography (CT)), neuropsychological evaluation including a Mini-Mental Status Examination (MMSE), CSF examination and other examinations according to "Haute Autorité de santé" (HAS, National Authority of Health, France) Recommendations - and in whom:
- lumbar puncture was not feasible for medical conditions
- results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
- lumbar puncture (LP) was refused by the patient
For all subjects the study will comprise 3 outpatient clinic visits to record information on previous work ups and to perform the FBB Positron Emission Tomography (PET) scan (Visit 1: screening/ baseline, Visit 2: PET scan, Visit 3: subject informed on the FBB PET scan result).
At Visit 1, the initial diagnosis based on previous work up will be collected and rated on a five-point Likert confidence scale by the Physician.
At Visit 2, the FBB PET scan will be performed. Adverse events will be reported during the exam and up to 7 days after the PET procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being evaluated for Alzheimer disease and related dementias according to the HAS recommendations (atypical dementia, early onset and rapid progressive dementia)
- •Patients who have previously been evaluated for AD and related dementias to whom a CSF examination was recommended in the last 12 months, but lumbar puncture was contraindicated or refused or CSF results were ambiguous, or
- •Patients currently being evaluated for AD and related dementias to whom a CSF examination is recommended but lumbar puncture is contraindicated or refused
- •Patients have a study partner who is willing and able to accompany him/her to all clinic visits for the duration of the protocol
- •Patients able to complete all clinical visits according to the protocol
- •Patients able to tolerate a 20-minute FBB PET scan
- •Patient or legal representative to provide informed consent for study participation, visits and data source verification.
排除标准
- •The subject had a previous beta amyloid imaging scan
- •Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- •Is currently receiving any investigational pharmaceutical product or has participated in a clinical trial with an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
- •For females of childbearing age, a positive pregnancy test
研究组 & 干预措施
Neuraceq (florbetaben 18F) PET scan
A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject.
The applied florbetaben radioactive dose will be ± 20%.
干预措施: Neuraceq (florbetaben 18F) (Drug)
Neuraceq (florbetaben 18F) PET scan
A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject.
The applied florbetaben radioactive dose will be ± 20%.
干预措施: PET (Procedure)
结局指标
主要结局
Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
时间窗: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
The Physician's diagnosis was assessed before and after FBB PET scan. The initial Physician's diagnosis was collected before the PET scan, at Visit 1, based on key diagnostic results of current or previous workup. After the PET scan, the final Physician's diagnosis was collected at Visit 3, based on the amyloid PET scan results.
次要结局
- Number of Subjects With Contraindicated or Failed Lumbar Puncture(Visit 1 (baseline evaluation))
- Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3(Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later))
- Number of Subjects With Negative FBB PET Scans(Visit 3 (up to 6 months after baseline evaluation))
- Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes(Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later))
- Number of Subjects With Positive FBB PET Scan(Visit 3 (up to 6 months after baseline evaluation))
- Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician(Visit 1 (baseline evaluation))
- Number of Subjects Who Refused Lumbar Puncture.(Visit 1 (baseline evaluation))