Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 2, 2008

Last Updated Date

December 17, 2008

Start Date ^†

February 2008

Current Primary Outcome Measures ^†

To evaluate the safety and tolerability of 2 dose levels of LX6171 oral suspension when administered for 28 days in subjects exhibiting AAMI. [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Plasma concentration [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ] [ Designated as safety issue: No ]
Cognitive assessment [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Official Title ^†

A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI)

Brief Summary

The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Age-Related Memory Disorders

Intervention ^†

Drug: LX6171 High Dose
Drug: LX6171 Low Dose
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

120

Completion Date

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Males and females aged 60-80 years old.
Complaints of memory loss in everyday life
Non-smokers or very light smokers (no more than 10 cigarettes/day)
Negative urine screen for drugs of abuse
Ability to provide written informed consent

Exclusion Criteria:

History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
Clinically significant abnormality on electrocardiogram
History of alcoholism or drug dependence
Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or DHA

Gender

Both

Ages

60 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691808

Responsible Party

Medical Director, Lexicon Pharmaceuticals, Inc.

Secondary IDs ^††

LX6171.201

Study Sponsor ^†

Lexicon Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Philip M. Brown, M.D., J.D.

Lexicon Pharmaceuticals, Inc.

Information Provided By

Lexicon Pharmaceuticals

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.