Alzheimer's Disease Education and Referral Center

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

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

Overall Status: 
Terminated
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
N/A
Both
No
Inclusion Criteria: 

    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
Exclusion Criteria: 
    • 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
Detailed Description: 

None provided.

Central Contact Information: 

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.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Name:
Phone:

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Name:
Phone:

Geolocation is 32.3312255, -111.0341183

Site
Tucson
Arizona
85741
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Name:
Phone:

Geolocation is 37.7929789, -122.4212424

Site
San Francisco
California
94109
Name:
Phone:

Geolocation is 39.8086537, -104.8337879

Site
Denver
Colorado
80239
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Name:
Phone:

Geolocation is 26.3424842, -80.1149414

Site
Boca Raton
Florida
33486
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Name:
Phone:

Geolocation is 26.5273497, -81.8333656

Site
Fort Myers
Florida
33912
Name:
Phone:

Geolocation is 29.1571921, -82.1223977

Site
Ocala
Florida
34471
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Name:
Phone:

Geolocation is 41.8816606, -87.6926257

Site
Chicago
Illinois
60612
Name:
Phone:

Geolocation is 38.0369642, -84.5379455

Site
Lexington
Kentucky
40504
Name:
Phone:

Geolocation is 41.8804637, -70.645473

Site
Plymouth
Massachusetts
02360
Name:
Phone:

Geolocation is 42.2513682, -70.9962875

Site
Qunicy
Massachusetts
02169
Name:
Phone:

Geolocation is 40.336419, -74.4330474

Site
Monroe Township
New Jersey
08831
Name:
Phone:

Geolocation is 42.6757698, -73.7860276

Site
Albany
New York
12206
Name:
Phone:

Geolocation is 36.025609, -78.9853813

Site
Durham
North Carolina
27705
Name:
Phone:

Geolocation is 39.7436233, -84.205486

Site
Dayton
Ohio
45408
Name:
Phone:

Geolocation is 45.5478224, -122.7288206

Site
Portland
Oregon
97210
Name:
Phone:

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Name:
Phone:
Lead Sponsor: 
Agency
Eli Lilly and Company
Collaborator Sponsor: 
Facility Investigators: 
RoleAffiliation
Study Director
Eli Lilly and Company
Study Contact: 
NamePhone
Eli Lilly
317-615-4559
Locations
 
x
ClinicalTrials.gov ID 
Official Title: 
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
Study Start Date: 
March 2012
Study End Date: 
February 2014
Disease Stage: 
Early
Enrollment: 
129