A 24-week, Three-site, Randomized, Double Blind, Placebo Controlled, Parallel Group, Proof-of-concept Study to Evaluate Rasagiline in the Regional Brain Metabolism on FDG PET in Patients With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
研究概览
简要总结
This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of concept three-site study, to evaluate the effect of Rasagiline in the regional brain metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).
详细描述
The study consists of two phases: a 24 week double blind placebo controlled treatment period and a 4 week follow up period. Patients will be randomized in a 1: 1 ratio at baseline to receive either Rasagiline or matching placebo
The study drug will be given as 0.5 mg dose once daily for the 4 weeks, then increases to 1 mg daily for the next 20 weeks. A total of 50 subjects will be enrolled: 25 will receive Rasagiline and 25 will receive matching placebo for the 24-week treatment period.
Primary objective is to determine if exposure to 1 mg of Rasagiline daily is associated with improved regional brain metabolism in the treatment group compared to the placebo group in Alzheimer's Disease patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Males or females 50 to 90 of age inclusive.
- •Diagnosis of probable AD (NINCDS-ADRDA criteria)
- •Positive fluoro-deoxyglucose PET ([18F]-FDG PET) scan compatible with AD as determined by the ADM Diagnostics LLC (ADMdx) Criteria at screening
- •Mini Mental Status Exam = 12 - 22 (inclusive)
- •Must have a study partner who is able and willing to comply with all required study procedures.
- •Have at least eight years of education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others in English.
- •If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of these agents has been stable for at least 3 months prior to screening
排除标准
- •Any non-AD neurological disease
- •MRI findings indication of a non-AD diagnosis
- •Screening laboratory studies that are 1.5 times above or below the highest and lowest range of normal for each test respectively
- •History of melanoma; history of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer
研究组 & 干预措施
Placebo
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
干预措施: Placebo (Drug)
Rasagiline
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
干预措施: Rasagiline (Drug)
结局指标
主要结局
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
时间窗: 24 weeks
The primary outcome measure is the change from baseline to week 24 in FDG-PET as measured by Standard Uptake Units Regional (SUVR) in several pre-specified brain regions including the medial temporal, lateral temporal, posterior cingulate - precuneus, inferior parietal, middle frontal, anterior cingulate, and striatum. The SUVR change was calculated by subtracting the value at 24 weeks from baseline values. Negative values indicate increased hypometabolism (i.e. worsening of cell function).
次要结局
- Change in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) Score(Mean change in scores from baseline to week 24)
- Change in MMSE (Mini Mental Status Examination) Score(Mean change in scores from baseline to week 24)
- Change in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) Score(Mean change in scores from baseline to week 24)
- Change in NPI (Neuropsychiatric Inventory) Score(Mean change in scores from baseline to week 24)
- Change in Digit Span(Mean change in scores from baseline to week 24)
- Change in COWAT (Controlled Oral Word Association Test) Score(Mean change in scores from baseline to week 24)
- Change in QoL-AD (Quality of Life - Alzheimer's Disease) Score(This assessment will be performed at the Baseline and Week 24 visits.)