Phase 1 N=61 Randomized Triple-blind Basic Science

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

Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT02624778 ↗

Enrolled (actual)

Serious AEs

9.8%

Results posted

Oct 2024

Primary outcome: Primary: Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) — -0.050; -0.122; -0.183; -0.255 standard uptake value ratio (SUVr) — p=0.309

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY3002813 (Biological); Placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)	-0.050; -0.122; -0.183; -0.255; -0.305; -0.419	0.309
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A	25700; 59400; 110000	—
SECONDARY 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	23000; 32900; 58900	—
SECONDARY PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C	29700; 35800; 68400	—
SECONDARY PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813	196; 413; 910; 223; 252; 564	—
SECONDARY PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C	273; 366; 598	—
SECONDARY Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813	13.3; 85.7; 100.0; 100.0; 100.0; 100.0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02624778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.