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

This study has been terminated.
(Study terminated due to abnormal liver biochemical tests in some participants.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01561430
First received: March 21, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

The purpose of this 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 who test positive for amyloid plaque.


Condition Intervention Phase
Alzheimer's Disease
Drug: LY2886721
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 12 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in plasma amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [ Time Frame: Baseline, 12 weeks, 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 weeks in Neuropsychological Test Battery (NTB) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 weeks in Mini Mental State Examination (MMSE) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in cerebrospinal fluid (CSF) tau and phosphorylated tau (ptau) 181 concentrations [ Time Frame: Baseline, 12 weeks, 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: March 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg LY2886721
15 mg capsules orally once daily for 26 weeks. This dose will not be administered to new subjects once the site has approval for the protocol amendment.
Drug: LY2886721
One capsule administered orally once daily
Experimental: 35 mg LY2886721
35 mg capsules orally once daily for 26 weeks
Drug: LY2886721
One capsule administered orally once daily
Placebo Comparator: Placebo
1 placebo capsule orally once daily for 26 weeks
Drug: Placebo
One capsule administered orally once daily
Experimental: 70 mg LY2886721
70 mg capsules orally once daily for 26 weeks
Drug: LY2886721
One capsule administered orally once daily

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561430

  Hide Study Locations
Locations
United States, Arizona
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, 85006
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Sun City, Arizona, United States, 85351
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Tucson, Arizona, United States, 85741
United States, California
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Long Beach, California, United States, 90806
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San Francisco, California, United States, 94109
United States, Colorado
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Denver, Colorado, United States, 80239
United States, Connecticut
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New Haven, Connecticut, United States, 06510
United States, Florida
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Boca Raton, Florida, United States, 33486
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Delray Beach, Florida, United States, 33445
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Fort Myers, Florida, United States, 33912
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32806
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West Palm Beach, Florida, United States, 33407
United States, Georgia
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Decatur, Georgia, United States, 30033
United States, Illinois
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Chicago, Illinois, United States, 60612
United States, Kentucky
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Lexington, Kentucky, United States, 40504
United States, Massachusetts
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Plymouth, Massachusetts, United States, 02360
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Qunicy, Massachusetts, United States, 02169
United States, New Jersey
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Monroe Township, New Jersey, United States, 08831
United States, New York
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Albany, New York, United States, 12206
United States, North Carolina
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Durham, North Carolina, United States, 27705
United States, Ohio
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Dayton, Ohio, United States, 45408
United States, Oregon
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Portland, Oregon, United States, 97210
United States, Utah
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Salt Lake City, Utah, United States, 84106
Italy
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Biella, Italy, 13900
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Pisa, Italy, 56126
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Rome, Italy, 00179
Japan
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Osaka, Japan, 545-8586
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Tokyo, Japan, 113
Netherlands
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Amsterdam, Netherlands, 1081 GM
Spain
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Barcelona, Spain, 08014
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Getafe, Spain, 28905
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Madrid, Spain, 28040
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Sant Cugal Del Valles, Spain, 08195
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01561430     History of Changes
Other Study ID Numbers: 13735, I4O-MC-BACC, 2011-005217-37
Study First Received: March 21, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Italy: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Eli Lilly and Company:
beta-secretase inhibitor

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014