Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT as a Marker of Acetylcholine Transporter Density in the Brain of Healthy Subjects and Patients With Alzheimer Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Does 123-I IBVM SPECT provide a quantitative measure of acetylcholinergic transporters in Healthy controls and AD patients?
研究概览
简要总结
The underlying goal of this study is to assess 123-I IBVM SPECT imaging as a tool to assess cholinergic transporter binding in the brain of AD and PD research participants and age- and gender-matched healthy subjects.
详细描述
Approximately 25 patients with mild to moderate Alzheimer's disease (AD) and 25 patients Parkinson's disease and 20 healthy controls will be recruited to participate in this study.
AD patients will be eligible to participate if they have a diagnosis of AD based on NINCDS-ADRDA criteria.
PD patients will be eligible to participate if they have a clinical diagnosis of Parkinson's disease.
Healthy controls will be evaluated to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation and cognitive assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant is 50 years or older.
- •Written informed consent is obtained.
- •Participants have a clinical diagnosis of Alzheimer's disease
- •Mini-Mental Status Exam score >10 and <
- •Modified Hachinski Ischemia Scale score of ≤
- •Geriatric Depression Scales (GDS) ≤
- •For females, non-child bearing potential or negative urine pregnancy test on day of 123-I IBVM injection.
- •Alzheimer's
排除标准
- •The subject has signs or symptoms of another neurodegenerative disease
- •Subjects with an iodine allergy.
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- •The subject has received an investigational drug within 60 days before the screening visit.
- •Pregnancy
- •Parkinson's Inclusion Criteria:
- •The participant is 30 years or older.
- •Written informed consent is obtained.
- •Participants have a clinical diagnosis of Parkinson's disease
- •Geriatric Depression Scales (GDS) ≤
- •For females, non-child bearing potential or negative urine pregnancy test on day of 123-I IBVM injection.
- •Parkinson's Exclusion Criteria:
- •Subjects with an iodine allergy.
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- •The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- •Pregnancy
研究组 & 干预措施
[123I]-IBVM
To assess [123I] IBVM and SPECT imaging
干预措施: [123I]-IBVM (Drug)
结局指标
主要结局
Does 123-I IBVM SPECT provide a quantitative measure of acetylcholinergic transporters in Healthy controls and AD patients?
时间窗: 24 hours
次要结局
- Does 123-I IBVM SPECT demonstrate reduced acetylcholinergic transporter binding in AD compared to healthy controls?(1 year)
- Does 123-I IBVM SPECT provide a reliable measure of acetylcholinergic transporters in healthy controls and AD patients?(2 weeks to 6 months)
研究者
Danna Jennings, MD
Principal Investigator
Institute for Neurodegenerative Disorders