Clinical trial NCT01561430 (phase 1/phase 2, status: terminated)
Conditions: alzheimer's disease
ICD codes: G30.8, G30.9, G30.0, G30.1
Drugs: ly2886721, placebo
SMILES: NC1=N[C@]2(COC[C@H]2CS1)C1=C(F)C=CC(NC(=O)C2=CC=C(F)C=N2)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    study terminated due to abnormal liver biochemical tests in some participants.
  
Eligibility 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