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

  • Terminated

The purpose of this Phase II study is to evaluate the effect of the drug LY886721, a beta-secretase inhibitor, in people with mild Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's who test positive for amyloid plaque.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A Both No
March 2012
February 2014
129

Participants with Mild Alzheimer's Disease

  • Mini Mental State Examination (MMSE) score of 20-26 inclusive
  • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's
  • Brain scan positive for the presence of amyloid beta
  • Clinical Dementia Rating Scale (CDR) score of 0.5 or 1

Participants with Mild Cognitive Impairment

  • MMSE score of 27-30 inclusive
  • Gradual and progressive change in memory function as reported by the participant or a caregiver during more than 6 months
  • Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46
  • Functional independence
  • No other known potential causes of cognitive decline
  • Brain scan positive for the presence of amyloid beta
  • Women must be postmenopausal; men must use a barrier method of contraception if their partners are pregnant or of childbearing potential
  • Participation in another drug or device study
  • Presence of dementia
  • History of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy, or other movement disorder
  • Serious infectious disease affecting the brain in the past 5 years; serious or repeat head injury
  • Significant retinal impairment or disease
  • Stroke or other circulation problems that affect current health
  • Positron emission tomography (PET) scan in the past 6 months
  • History of seizure; major depressive disorder or other severe mental illness such as schizophrenia or bipolar disorder; history of alcohol or drug abuse
  • Asthma, chronic obstructive pulmonary disease (COPD), or other breathing disease that is not controlled with medicine
  • Human immunodeficiency virus (HIV) or syphilis
  • Prohibited medications: blood thinners; acetylcholinesterase inhibitors and memantine allowed if stable

None provided.

For more information about this trial, please call Eli Lilly at 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Monday through Friday, 9 a.m. to 5 p.m. Eastern time.

Name City State Zip Status Primary Contact
Site Phoenix Arizona 85006

Site Sun City Arizona 85351

Site Tucson Arizona 85741

Site Long Beach California 90806

Site San Francisco California 94109

Site Denver Colorado 80239

Site New Haven Connecticut 06510

Site Boca Raton Florida 33486

Site Delray Beach Florida 33445

Site Fort Myers Florida 33912

Site Ocala Florida 34471

Site Orlando Florida 32806

Site West Palm Beach Florida 33407

Site Decatur Georgia 30033

Site Chicago Illinois 60612

Site Lexington Kentucky 40504

Site Plymouth Massachusetts 02360

Site Qunicy Massachusetts 02169

Site Monroe Township New Jersey 08831

Site Albany New York 12206

Site Durham North Carolina 27705

Site Dayton Ohio 45408

Site Portland Oregon 97210

Site Salt Lake City Utah 84106

Eli Lilly and Company

Name Role Affiliation
Study Director Eli Lilly and Company

Name Phone Extension Email
Eli Lilly 317-615-4559

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