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

Sponsored by:	Lexicon Pharmaceuticals
Information provided by:	Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00691808

Purpose

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).

Condition	Intervention	Phase
Age-Related Memory Disorders	Drug: LX6171 High Dose Drug: LX6171 Low Dose Drug: Placebo	Phase II

MedlinePlus related topics: Memory

U.S. FDA Resources

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

Further study details as provided by Lexicon Pharmaceuticals:

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 ]

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 ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High Dose: Experimental	Drug: LX6171 High Dose A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Low Dose: Experimental	Drug: LX6171 Low Dose A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Placebo: Placebo Comparator	Drug: Placebo Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691808

Locations

Netherlands
Kendle Netherlands
Utrecht, Netherlands, 3584
Pharmaceutical Research Associates Group BV
Zuidlaren, Netherlands, 9470

Sponsors and Collaborators

Lexicon Pharmaceuticals

Investigators

Study Director:

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

Lexicon Pharmaceuticals, Inc.

More Information

Responsible Party:	Lexicon Pharmaceuticals, Inc. ( Medical Director )
Study ID Numbers:	LX6171.1-201-AAMI, LX6171.201
Study First Received:	June 2, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00691808
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009