EUCTR2011-005217-37-NL进行中（未招募）不适用
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- •[1] Present with MCI due to AD or mild AD based on the disease diagnostic criteria
- •[2]Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years. Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods.
- •[3]Have a reliable caregiver/study informant who provides a separate written informed consent to participate and who has sufficient contact with the patient to provide information about the patient’s daily activities. The caregiver/study informant must be able to communicate with site personnel and in the investigator’s opinion must have adequate literacy to complete the protocol-specified questionnaires. If a caregiver/study informant cannot continue, 1 replacement is allowed.
- •[4] Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
- •[5] Have adequate premorbid literacy in the investigator’s opinion to complete the required psychometric tests
- •[6] Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
- •Disease Diagnostic Criteria
- •Patients with MCI due to AD or mild AD will be selected according to the following criteria:
- •- Gradual and progressive change in memory function reported by patient or caregiver/study informant over more than 6 months.
- •- Objective evidence of significantly impaired episodic memory characteristic of hippocampal dysfunction on testing: Free and Cued Selective Reminding Test with Immediate Recall (FCSRT – IR): =16 for free recall or =40 for total recall. The episodic memory impairment can be isolated or associated with other cognitive changes at the onset of AD or as AD advances.
- •- Clinical Dementia Rating Scale (CDR) = 0.5 or 1, memory box score =0.5
- •- Mini Mental State Examination (MMSE) 20 to 30
- •- florbetapir F18 scan positive for the presence of Aß(based on central review)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Participant in another drug or device study
- •Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease or Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder
- •Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than two months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed
- •Have had a serious infectious disease affecting the brain in the past 5 years
- •Have had a serious or repeat head injury
- •Have significant retinal impairment or disease
- •Have had a stroke or other circulation problems that are affecting your current health
- •Have had a positron emission tomography (PET) scan in the past 6 months
- •Have had a seizure
- •Have major depressive disorder (participation is allowed if depressive symptoms are treated with stabile administration of antidepressants) or another mental illness such as schizophrenia or bipolar disorder
- •History of alcohol or drug abuse
- •Have asthma, chronic obstructive pulmonary disease (COPD) or other breathing disease that is not controlled with medicine
- •Have human immunodeficiency virus (HIV) or syphilis
- •Have any medical condition requiring double and triple anti-platelet treatment (for example, combination of aspirin with Clopidogrel, and/or Cilostazol). Note: single antiplatelet therapy is not an exclusion criteria.
研究者
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