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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00329082

Purpose

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

Condition	Intervention	Phase
Alzheimer's Disease	Drug: LY2062430 Drug: Placebo	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the plasma pharmacokinetics of LY2062430 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To evaluate the changes in thinking and memory [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	May 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: LY2062430 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks
2: Experimental	Drug: LY2062430 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks
3: Experimental	Drug: LY2062430 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks
4: Experimental	Drug: LY2062430 100mg QW IV for 12 weeks 100mg Q4W IV for 12 weeks 400mg QW IV for 12 weeks 400mg Q4W IV for 12 weeks
5: Placebo Comparator	Drug: Placebo 5: Placebo QW IV for 12 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329082

Locations

United States, Connecticut
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, 06510
United States, District of Columbia
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, District of Columbia, United States, 20007
United States, Indiana
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, 46202
United States, Missouri
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, 63108
United States, New York
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, 14603
United States, Pennsylvania
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, 19104

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	6649, H8A-MC-LZAJ
Study First Received:	May 19, 2006
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00329082 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Healthy

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009