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

NCT ID: NCT01561430

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this Phase 1/Phase 2 study is to evaluate how the body handles the drug and the drug's effect on the body of participants with mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD and who test positive for amyloid plaque.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

15 mg LY2886721

LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.

Group Type: EXPERIMENTAL

LY2886721

Intervention Type: DRUG

35 mg LY2886721

LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.

Group Type: EXPERIMENTAL

LY2886721

Intervention Type: DRUG

70 mg LY2886721

LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.

Group Type: EXPERIMENTAL

LY2886721

Intervention Type: DRUG

Placebo

Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

LY2886721

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Meets criteria for MCI due to AD or Mild AD

All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening

• Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the criteria for mild AD, as follows:

• Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
• Clinical Dementia Rating Scale (CDR) score of 0.5 or 1
• Positive scan for the presence of amyloid beta
• Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following criteria:

• Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months
• Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46
• Absence of dementia
• Preservation of functional independence
• Exclusion of other potential (vascular, traumatic, or medical) causes of cognitive decline, where possible
• Positive scan for the presence of amyloid beta
• Women must be postmenopausal
• 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

Exclusion Criteria

• Participant in another drug or device study
• Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, 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 2 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 current health
• Have had a seizure
• Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) criteria for major depression may be included
• History of schizophrenia, bipolar disorder, or severe mental illness
• 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
• Are taking blood thinners

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Phoenix, Arizona, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sun City, Arizona, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tucson, Arizona, United States

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Long Beach, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Boca Raton, Florida, United States

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Delray Beach, Florida, United States

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Fort Myers, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Plymouth, Massachusetts, United States

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Quincy, Massachusetts, United States

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Monroe, New Jersey, United States

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Albany, New York, United States

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Durham, North Carolina, United States

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Dayton, Ohio, United States

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Portland, Oregon, United States

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Salt Lake City, Utah, United States

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Biella, , Italy

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Pisa, , Italy

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Rome, , Italy

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Osaka, , Japan

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Tokyo, , Japan

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Amsterdam, , Netherlands

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Barcelona, , Spain

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Getafe, , Spain

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Madrid, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sant Cugal Del Valles, , Spain

Countries

United States; Italy; Japan; Netherlands; Spain

Other Identifiers

I4O-MC-BACC

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005217-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13735

Identifier Type: -

Identifier Source: org_study_id