Clinical trial NCT00244322: Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease
Official title: LY450139: Tolerability and Biomarker Assessment in Subjects With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-10-26
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purposes of this study are to determine:

* The safety of LY450139 dihydrate and any side effects that might be associated with it.
* How much LY450139 dihydrate should be given and how long it may be detected in blood.
* To determine if LY450139 dihydrate may have an effect on a protein found in blood, called A beta. This protein is studied in subjects with Alzheimer's disease.
* To collect and store samples from blood and spinal fluid for research related to Alzheimer's disease and similar (neurodegenerative) diseases or inflammation (irritation) that may provide information on how subjects respond to LY450139 or other medications.

Length of study: Approximately 29 weeks.

Number of office visits: 11 for most subjects: initial visit, every other week during 14 weeks of study drug treatment, and 2 follow-up visits.

At no cost, approximately 45 eligible participants will receive:

* Study medication
* Study-related diagnostic and laboratory evaluations


Eligibility criteria: Inclusion Criteria:

* At least 50 years of age and diagnosed with mild to moderate probable Alzheimer's disease
* Fluent in reading and speaking English and have a reliable study partner (caregiver) (someone who is in frequent contact and can make sure study medication is being taken correctly).
* If currently treated with certain drugs for Alzheimer's disease, doses must be the same for at least the last 2 months prior to starting study drug.

Exclusion Criteria:

* Cannot be currently using or require MAOI antidepressants (such as selegiline or Eldepryl(R)), antipsychotics, benzodiazepines, calcium channel blockers for heart disease, and propanolol.
* Cannot have a clinically significant and/or uncontrolled condition or other significant disease, including a condition requiring treatment with warfarin or heparin; or have had or currently have a peptic ulcer, reflux disease, or gastrointestinal (GI) bleeding.

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Determine levels of peptides in blood and spinal fluid that might relate to Alzheimer's disease
measure: Evaluate changes in thinking and memory
measure: Evaluate changes in daily living activities
measure: Determine levels of study drug in blood and spinal fluid
Other outcomes:
Locations:
city: La Jolla
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 - 5hours, EST), or speak with your personal physician
state: California
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 - 5hours, EST), or speak with your personal physician
state: Indiana
city: Saint 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 - 5hours, EST), or speak with your personal physician
state: Missouri
city: Portland
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 - 5hours, EST), or speak with your personal physician
state: Oregon
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 - 5hours, EST), or speak with your personal physician
state: Pennsylvania
city: Seattle
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 - 5hours, EST), or speak with your personal physician
state: Washington
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:
citation: Portelius E, Dean RA, Gustavsson MK, Andreasson U, Zetterberg H, Siemers E, Blennow K. A novel Abeta isoform pattern in CSF reflects gamma-secretase inhibition in Alzheimer disease. Alzheimers Res Ther. 2010 Mar 29;2(2):7. doi: 10.1186/alzrt30.
citation: Fleisher AS, Raman R, Siemers ER, Becerra L, Clark CM, Dean RA, Farlow MR, Galvin JE, Peskind ER, Quinn JF, Sherzai A, Sowell BB, Aisen PS, Thal LJ. Phase 2 safety trial targeting amyloid beta production with a gamma-secretase inhibitor in Alzheimer disease. Arch Neurol. 2008 Aug;65(8):1031-8. doi: 10.1001/archneur.65.8.1031.