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

Lilly

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: LY2886721; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561430

2011-005217-37 (EudraCT Number)

I4O-MC-BACC (Other Identifier)

13735

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 4 patient groups, including a placebo group

15 mg LY2886721

Experimental group

Description:

LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.

Treatment:

Drug: LY2886721

35 mg LY2886721

Experimental group

Description:

LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.

Treatment:

Drug: LY2886721

70 mg LY2886721

Experimental group

Description:

LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.

Treatment:

Drug: LY2886721

Placebo

Placebo Comparator group

Description:

Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.

Treatment:

Drug: Placebo