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:
Recruiting
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 Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | N/A | Both | No |
Inclusion Criteria:
- 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
- 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
Participants with Mild Alzheimer's Disease
Participants with Mild Cognitive Impairment
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 | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 0, 0 | Site | Phoenix | Arizona | 85006 | Recruiting |
Geolocation is 0, 0 | Site | Sun City | Arizona | 85351 | Recruiting |
Geolocation is 0, 0 | Site | Tucson | Arizona | 85741 | Recruiting |
Geolocation is 0, 0 | Site | Long Beach | California | 90806 | Recruiting |
Geolocation is 0, 0 | Site | San Francisco | California | 94109 | Recruiting |
Geolocation is 0, 0 | Site | Denver | Colorado | 80239 | Recruiting |
Geolocation is 0, 0 | Site | New Haven | Connecticut | 06510 | Recruiting |
Geolocation is 0, 0 | Site | Boca Raton | Florida | 33486 | Recruiting |
Geolocation is 0, 0 | Site | Delray Beach | Florida | 33445 | Recruiting |
Geolocation is 0, 0 | Site | Fort Myers | Florida | 33912 | Recruiting |
Geolocation is 0, 0 | Site | Ocala | Florida | 34471 | Recruiting |
Geolocation is 0, 0 | Site | Orlando | Florida | 32806 | Recruiting |
Geolocation is 0, 0 | Site | West Palm Beach | Florida | 33407 | Recruiting |
Geolocation is 0, 0 | Site | Decatur | Georgia | 30033 | Recruiting |
Geolocation is 0, 0 | Site | Chicago | Illinois | 60612 | Recruiting |
Geolocation is 0, 0 | Site | Lexington | Kentucky | 40504 | Recruiting |
Geolocation is 0, 0 | Site | Plymouth | Massachusetts | 02360 | Recruiting |
Geolocation is 0, 0 | Site | Qunicy | Massachusetts | 02169 | Recruiting |
Geolocation is 0, 0 | Site | Eatontown | New Jersey | 07724 | Recruiting |
Geolocation is 0, 0 | Site | Albany | New York | 12205 | Recruiting |
Geolocation is 0, 0 | Site | Durham | North Carolina | 27705 | Recruiting |
Geolocation is 0, 0 | Site | Dayton | Ohio | 45408 | Recruiting |
Geolocation is 0, 0 | Site | Portland | Oregon | 97210 | Recruiting |
Geolocation is 0, 0 | Site | Salt Lake City | Utah | 84106 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Eli Lilly and Company |
Collaborator Sponsor:
Facility Investigators:
| Role | Affiliation |
|---|---|
Study Director | Eli Lilly and Company |
Study Contact:
| Name | Phone |
|---|---|
Eli Lilly | 317-615-4559 |
Locations
x
ClinicalTrials.gov ID
NCT01561430 (follow link to view full record on ct.gov in new window)
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
