Effect of Oral EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal Elderly. Phase II, Randomised, Double-blind, Parallel Groups, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)
研究概览
简要总结
The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE 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
- Double (Participant, Investigator)
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
- •Group Specific Inclusion Criteria:
- •Cognitively normal elderly (CNE)
- •Spontaneous memory complaint by patient,
- •Mini-Mental State Exam score ≥
- •Clinical Dementia Rating =
- •No Diagnostic And Statistical Manual Of Mental Disorders, Fourth Edition (DSMIV) criteria for Dementia.
- •Memory complaints (MC) :
- •Spontaneous memory complaint by patient
- •Mini-Mental State Exam score ≥ 25
- •Clinical Dementia Rating 0.
- •No DSMIV criteria for Dementia.
- •Mild Alzheimer's Disease (AD):
- •Mini Mental Status Examination (MMSE) between 20 and 28 (inclusive).
- •Clinical Dementia Rating ≥ 1.0
- •DSMIV criteria for Dementia.
- •National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer's Disease and Related Disorders Association(NINCDS/ADRDA) criteria for probable AD.
- •Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantine.
- •≥ 65 years of age, both sex
- •Geriatric Depression Scale (GDS) < 15
- •Informed consent signed by the patient or, if necessary by legal representative
排除标准
- •Contraindication to Magnetic Resonance Imaging (MRI) and/or Positron-Emission Tomography (PET) scan
- •Forbidden Concomitant medications (Cholinesterase inhibitors and memantine, Specific psychoactive medications,e.g., neuroleptics, chronic anxiolytics including meprobamate, or sedative hypnotics other than benzodiazepines, Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Drugs acting on cerebral nervous system, Antidiabetes medications , Antioxidants medications, Medications known to interfere with cognitive evaluations
- •Significant neurological disease and psychiatric disorders/psychotic feature
- •Significant medical illness
研究组 & 干预措施
EGb 120 mg
干预措施: EGb761® (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)
时间窗: From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase
Following statistical parametric mapping (SPM) analyses were performed by the Commissariat à l'Energie Atomique (CEA): * The comparison between treatment groups separately for each group of elderly subjects (CNE and MC groups only) * The comparison between the two groups of elderly subjects (CNE and MC groups only) by treatment group FDG PET demonstrates reductions in the cerebral glucose metabolism that may occur a few years before the overt clinical manifestation of disease. SUVBSA2 = \[Brain radioactivity (Bq/cc)\] / \[Injected dose (MBq)/BSA2\] x \[Blood glucose (g/l)\] BSA2(m\^2) = 0.007184 x Height (cm)\^0.35 x weight (kg)\^0.80 Standardized Uptake Value (SUV) Body Surface Area (BSA)
次要结局
- Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups(From Baseline (Month 0) to Month 9)
- Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups(From Baseline (Month 0) to Month 9)
- Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)(At Month 18)
- Change in Brain Glucose Metabolism in the MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups(From Baseline (Month 0) to Month 9)
- Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups(From Baseline (Month 0) to Month 9)
- Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups(From Baseline (Month 0) to Month 9)
- Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT)(From Baseline (Month 0) to Month 9)
- Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer's)(At Month 18)
- Change in Cognitive Tests-CDR Score in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-GDS Score in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-MMSE Score in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups(From Baseline (Month 0) to Month 18)
- Incidence of Adverse Events (AEs)(Up to Month 18)
- Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size(From Baseline (Month 0) to Month 18)