Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers

Phase 2CompletedNCT00329082

Eli Lilly and Company25 enrolled

Overview

To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

LY2062430DRUG

1. 100mg QW IV for 12 weeks 2. 100mg Q4W IV for 12 weeks 3. 400mg QW IV for 12 weeks 4. 400mg Q4W IV for 12 weeks

PlaceboDRUG

5: Placebo QW IV for 12 weeks

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * At least 50 years of age and diagnosed with mild to moderate Alzheimer's disease or healthy volunteers * fluent in reading and speaking English * AD patients must have a reliable study partner who will be in frequent contact with the patient and comply with protocol requirements * AD patients who have received AChEIs or memantine for at least 4 months and on stable therapy for at least 2 months prior to starting study drug Exclusion Criteria: * Have a history of serious infectious disease affecting the brain, head trauma, cancer, drug or alcohol abuse in the past 5 years * Have serious or uncontrolled health problems or laboratory tests * Multiple or severe drug allergies * Prior participation in an active immunization study

Locations (6)

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.

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Safety and tolerability

Time frame: 1 year

Secondary Outcomes

To determine the plasma pharmacokinetics of LY2062430

Time frame: 1 year

To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations

Time frame: 1 year

To evaluate the changes in thinking and memory

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.