Clinical trial NCT00329082: Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers
Official title: LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Safety and tolerability
timeFrame: 1 year
Secondary outcomes:
measure: To determine the plasma pharmacokinetics of LY2062430
timeFrame: 1 year
measure: To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations
timeFrame: 1 year
measure: To evaluate the changes in thinking and memory
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: 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.
state: Connecticut
city: Washington
country: United States
facility: 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.
state: District of Columbia
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: St Louis
country: United States
facility: 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.
state: Missouri
city: Rochester
country: United States
facility: 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.
state: New York
city: Philadelphia
country: United States
facility: 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.
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: