EUCTR2007-005377-63-FR进行中（未招募）1 期
Effect of oral EGb 761® 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
Beaufour Ipsen pharma0 个研究点目标入组 49 人开始时间: 2008年1月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Enrolled patients will be = 70 years of age, both sex.
- •-All patients must be willing and able to undergo all test procedures including neuroimaging.
- •-All patients must have a referent.
- •-Informed consent signed by the patient or, if necessary by legal representative
- •-Life expectancy more than two years.
- •-Geriatric depression scale (GDS) <15.
- •Group Specific Inclusion Criteria
- •Cognitively normal elderly (CNE)
- •- Spontaneous memory complaint by patient,
- •- Mini-Mental State Exam score = 28.
- •- Clinical Dementia Rating = 0.
- •- No DSMIV criteria for Dementia.
- •Memory complaints (MC) :
- •- Spontaneous memory complaint by patient
- •- Mini-Mental State Exam score = 25
- •- Clinical Dementia Rating 0.5.
- •- No DSMIV criteria for Dementia.
- •Mild Alzheimer’s Disease (AD):
- •- MMSE between 20 and 28 (inclusive).
- •- Clinical Dementia Rating = 1.0
- •- DSMIV criteria for Dementia.
- •- NINCDS/ADRDA criteria for probable AD.
- •- Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantin
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Contraindication to MRI and/or PET scan: surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) pacemaker or other pieces of metal in the body (shrapnel, metal filings). Claustrophobia.
- •- Known hypersensitivity to Gingko biloba extract.
- •- Participation in another experimental drug trial at the same time or being in an exclusion period.
- •- Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- •- Forbidden Concomitant medications:
- •-Cholinesterase inhibitors and memantine,
- •-Specific psychoactive medications (e.g., neuroleptics, chronic anxiolytics including meprobamate or sedative hypnotics, Selective serotonin reuptake inhibitor (SSRI), Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Doses for antidepressants considered as stable for investigator will be permitted.
- •-Drugs acting on cerebral nervous system
- •-Antidiabetes medications
- •-Antioxidants medications.
- •-Medications known to interfere with cognitive evaluations .
- •- Significant neurological disease:
- •Any significant neurological disease, such as Parkinson’s disease, vascular dementia or degenerative dementia other than mild AD, Huntington’s disease, normal pressure hydrocephalus, brain tumour, progressive supra nuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurological defaults or known structural brain abnormalities.
- •- Psychiatric disorders/psychotic features:
- •-Major depression, bipolar disorder within the past 1 year.
- •-History of schizophrenia.
- •-Psychotic features, agitation or behavioural problems within the last 3 months which could lead to difficulty complying with the protocol.
- •- Alcohol and/or drug abuse:
- •History of alcohol or substance abuse or dependence within the past 2 years.
- •- Significant medical illness:
- •Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
研究者
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