A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

Lilly

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Biological: LY3002813; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02624778

I5T-MC-AACD (Other Identifier)

16233

Details and patient eligibility

About

The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD.

The study involves 3 parts.

• Part A in which participants will receive a single dose of LY3002813 or placebo (no drug).
• Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks.
• Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks.

Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.

Enrollment: 61 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
• Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
• Have up to 2 partners who will provide a separate written informed consent to participate
• Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
• Positive florbetapir scan

Exclusion criteria

• Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
• Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
• History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
• Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
• Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
• Have gamma globulin therapy within the last year
• Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
• Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
• Have current serious or unstable illnesses

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 9 patient groups, including a placebo group

Part A: Placebo Single Dose (SD)

Placebo Comparator group

Description:

Participants received single intravenous (IV) dose of placebo.

Treatment:

Drug: Placebo

Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD

Experimental group

Description:

Participants received single IV dose of 10 mg/kg LY3002813.

Treatment:

Biological: LY3002813

Part A: 20 mg/kg LY3002813 SD

Experimental group

Description:

Participants received single IV dose of 20 mg/kg LY3002813.

Treatment:

Biological: LY3002813

Part A: 40 mg/kg LY3002813 SD

Experimental group

Description:

Participants received single IV dose of 40 mg/kg LY3002813.

Treatment:

Biological: LY3002813

Part B: Placebo Q2W

Placebo Comparator group

Description:

Participants received multiple IV dose of placebo every 2 weeks (Q2W) for 24 weeks.

Treatment:

Drug: Placebo

Part B: 10 mg/kg LY3002813 Q2W

Experimental group

Description:

Participants received multiple IV dose of 10 mg/kg LY3002813 Q2W for 24 weeks.

Treatment:

Biological: LY3002813

Part C: Placebo Q4W

Placebo Comparator group

Description:

Participants received multiple IV dose of placebo every 4 weeks (Q4W) for 72 weeks.

Treatment:

Drug: Placebo

Part C:10 mg/kg LY3002813 Q4W

Experimental group

Description:

Participants received multiple IV dose of 10 mg/kg LY3002813 Q4W for 72 weeks.

Treatment:

Biological: LY3002813

Part C:20 mg/kg LY3002813 Q4W

Experimental group

Description:

Participants received multiple IV dose of 20 mg/kg LY3002813 Q4W for 72 weeks.

Treatment:

Biological: LY3002813