Assessment of Safety, Tolerability, and Pharmacodynamic Effects ofLY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer'sDisease or Mild Alzheimer's Disease

ELI LILLY AND COMPANY0 个研究点目标入组 260 人开始时间: 2012年9月14日最近更新: 2014年2月17日

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•Present with MCI due to AD or mild AD based on the disease diagnostic criteria.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.Have a reliable caregiver/study informant who provides a separate written informed consent to participate and who is in frequent contact with the patient (defined as at least 10 hours per week). 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.Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator.Have adequate premorbid literacy in the investigator's opinion to complete the required psychometric tests.Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•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

•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.

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