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

NCT02624778 | Completed Phase 1 Results

• 2 other identifiers: 16233I5T-MC-AACD
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)

  Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.

  Baseline, Week 72

Secondary Outcomes (6)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A

  Predose, end of infusion, 3, 24 and 48 hours postdose

• Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C

  Predose, end of infusion, 3, 24, 48 and 72 hours postdose

• PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C

  Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose

• PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813

  Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose

• PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C

  Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose

Study Arms (9)

Part A: Placebo Single Dose (SD)

PLACEBO COMPARATOR

Participants received single intravenous (IV) dose of placebo.

Drug: Placebo

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

EXPERIMENTAL

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

Biological: LY3002813

Part A: 20 mg/kg LY3002813 SD

EXPERIMENTAL

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

Biological: LY3002813

Part A: 40 mg/kg LY3002813 SD

EXPERIMENTAL

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

Biological: LY3002813

Part B: Placebo Q2W

PLACEBO COMPARATOR

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

Drug: Placebo

Part B: 10 mg/kg LY3002813 Q2W

EXPERIMENTAL

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

Biological: LY3002813

Part C: Placebo Q4W

PLACEBO COMPARATOR

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

Drug: Placebo

Part C:10 mg/kg LY3002813 Q4W

EXPERIMENTAL

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

Biological: LY3002813

Part C:20 mg/kg LY3002813 Q4W

EXPERIMENTAL

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

Biological: LY3002813

Interventions

LY3002813 BIOLOGICAL

Administered IV

Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD; Part A: 20 mg/kg LY3002813 SD; Part A: 40 mg/kg LY3002813 SD; Part B: 10 mg/kg LY3002813 Q2W; Part C:10 mg/kg LY3002813 Q4W; Part C:20 mg/kg LY3002813 Q4W

Placebo DRUG

Administered IV

Part A: Placebo Single Dose (SD); Part B: Placebo Q2W; Part C: Placebo Q4W

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Compass Research

The Villages, Florida, 32162, United States

Location

SNBL Clinical Pharmacology Center Inc

Baltimore, Maryland, 21201, United States

Location

St. Louis Clinical Trials, LC

St Louis, Missouri, 63141, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Location

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.

Shinjuku-Ku, 162-0053, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Shinjuku-Ku, 169-0073, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Sumida-ku, 130-0004, Japan

Location

Related Links

• Click here for more information about this study: A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD)

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 8, 2015
• Study Start: December 22, 2015
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Locations

JP (3); US (6)