Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00051909

Recruitment Status : Completed

First Posted : January 20, 2003

Last Update Posted : July 19, 2006

Sponsor:

Information provided by:

Eli Lilly and Company

Tracking Information

First Submitted Date ^ICMJE

January 17, 2003

First Posted Date ^ICMJE

January 20, 2003

Last Update Posted Date

July 19, 2006

Study Start Date ^ICMJE

November 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease

Official Title ^ICMJE

Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease

Brief Summary

Study of an investigational medication for the treatment of Alzheimer's Disease in patients who are not taking Aricept, Reminyl, Exelon.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: LY451395

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

June 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must have a clinical diagnosis of Alzheimer's Disease
Must be at least 50 years of age
Must fluently read and speak English
Must have a reliable caregiver

Exclusion Criteria:

Has serious health problems other than Alzheimer's Disease
Cannot swallow whole pills
Has had a menstrual period in the last two years
Takes insulin for diabetes
Has taken Aricept, Reminyl, or Exelon in the last 5 weeks

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

50 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00051909

Other Study ID Numbers ^ICMJE

6764
H6N-MC-LEAM

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Eli Lilly and Company

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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