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

NCT ID: NCT00329082

Last Updated: 2009-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

LY2062430

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

LY2062430

Intervention Type DRUG

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

3

Group Type EXPERIMENTAL

LY2062430

Intervention Type DRUG

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

4

Group Type EXPERIMENTAL

LY2062430

Intervention Type DRUG

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

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5: Placebo QW IV for 12 weeks

Interventions

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LY2062430

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

Intervention Type DRUG

Placebo

5: Placebo QW IV for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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.

Washington D.C., District of Columbia, United States

Site Status

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.

Indianapolis, Indiana, United States

Site Status

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.

St Louis, Missouri, United States

Site Status

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.

Rochester, New York, United States

Site Status

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.

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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H8A-MC-LZAJ

Identifier Type: -

Identifier Source: secondary_id

6649

Identifier Type: -

Identifier Source: org_study_id

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