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

March 21, 2012
January 7, 2014
March 2012
August 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01561430 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Alzheimer's Disease
  • Drug: LY2886721
    One capsule administered orally once daily
  • Drug: Placebo
    One capsule administered orally once daily
  • 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.
    Intervention: Drug: LY2886721
  • Experimental: 35 mg LY2886721
    35 mg capsules orally once daily for 26 weeks
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo
    1 placebo capsule orally once daily for 26 weeks
    Intervention: Drug: Placebo
  • Experimental: 70 mg LY2886721
    70 mg capsules orally once daily for 26 weeks
    Intervention: Drug: LY2886721
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
128
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Italy,   Japan,   Netherlands
 
NCT01561430
13735, I4O-MC-BACC, 2011-005217-37
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP