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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01561430
Recruitment Status : Terminated (Study terminated due to abnormal liver biochemical tests in some participants.)
First Posted : March 23, 2012
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY2886721 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 15 mg LY2886721
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
 Drug: LY2886721
Experimental: 35 mg LY2886721
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
 Drug: LY2886721
Experimental: 70 mg LY2886721
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
 Drug: LY2886721
Placebo Comparator: Placebo
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations [ Time Frame: Baseline, 12 weeks ]
    Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.

  2. Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations [ Time Frame: Baseline, 26 weeks ]
    Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 26 weeks post-dose was to be calculated. The units for CSF were picograms per milliliter (pg/mL). LS means of percent change in concentration from baseline was calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.


Secondary Outcome Measures :
  1. Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations [ Time Frame: Baseline, 12 weeks, 26 weeks ]
    Percent change in plasma concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL).

  2. Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB) [ Time Frame: Baseline, 26 weeks ]
    The NTB is a composite cognitive measure in clinical Alzheimer's disease studies and is a collection of several written and oral tests that examines verbal and nonverbal brain functions. NTB Z-score typically ranges from -3 to 3, with lower scores suggesting greater cognitive impairment. LS means were calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.

  3. Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: Baseline, 26 weeks ]
    ADAS-Cog11 is an 11-item instrument measuring impairment in memory (Items 1-4, 7, 11), praxis (Items 4 and 5), orientation (Item 6), and language (Items 8-10). Item 1 ranged 0 (all items recalled correctly)-10 (none recalled correctly); Items 2-5 and 8-11 ranged 0 (all items named, performed, drawn, spoken, remember correctly/clearly)-5 (none correct/not clearly spoken); Item 6 ranged 0 (no incorrect responses)-8 (all incorrect); and Item 7 ranged 0 (all words remembered correctly)-12 (no words remembered correctly) for a total ADAS-Cog11 score of 0-70 with higher scores indicating greater disease severity. A score of 0-10 for delayed free recall and a conversion code of 0-5 for digit cancellation and maze completion was added to the total ADAS-Cog11 score for a total ADAS-Cog14 score ranging 0-90 with higher scores indicating greater impairment. LS means were calculated using Mixed Model Repeated Measures (MMRM) with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.

  4. Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 26 weeks ]
    The CDR-SB is a composite measure of 6 domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores ranged from 0 to 18, with higher scores indicating greater impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.

  5. Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE) [ Time Frame: Baseline, 26 weeks ]
    The MMSE (Folstein et al. 1975) is one of the most widely used screening instruments for cognitive impairment. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and provides a total score ranging from 0 to 30, with lower scores indicative of greater cognitive impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.

  6. Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations [ Time Frame: Baseline, 12 weeks, 26 weeks ]
    Percent change in lumbar CSF tau and ptau-181 concentrations from baseline at 12 weeks post-dose and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561430


Locations
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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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Quincy, Massachusetts, United States, 02169
United States, New Jersey
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Monroe, 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
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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
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Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01561430    
Other Study ID Numbers: 13735
I4O-MC-BACC ( Other Identifier: Eli Lilly and Company )
2011-005217-37 ( EudraCT Number )
First Posted: March 23, 2012    Key Record Dates
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by Eli Lilly and Company:
beta-secretase inhibitor
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders