CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
LY3002813 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02624778
NCT02624778Phase 1Completed

A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Eli Lilly and Company·interventional·Posted Dec 8, 2015·Updated Oct 8, 2024

In Brief

A Phase 1 clinical trial evaluating LY3002813 and Placebo for Alzheimer Disease. Completed, enrolled 61 participants across 9 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 8, 2015
Enrollment StartDec 22, 2015
Primary CompletionAug 28, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.6 years ago

Interventions

LY3002813biological

Administered IV

Placebodrug

Administered IV