Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Conditions: Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease
MedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-005217-37-NL

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 260

Inclusion Criteria

[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

Exclusion Criteria

•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.