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Sponsored by: |
Lexicon Pharmaceuticals |
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Information provided by: | Lexicon Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00691808 |
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 |
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Age-Related Memory Disorders |
Drug: LX6171 High Dose Drug: LX6171 Low Dose Drug: Placebo |
Phase II |
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) |
Estimated Enrollment: | 120 |
Study Start Date: | February 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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.
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Placebo: Placebo Comparator |
Drug: Placebo
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
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Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Kendle Netherlands | |
Utrecht, Netherlands, 3584 | |
Pharmaceutical Research Associates Group BV | |
Zuidlaren, Netherlands, 9470 |
Study Director: | Philip M. Brown, M.D., J.D. | Lexicon Pharmaceuticals, Inc. |
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) |
Signs and Symptoms Neurologic Manifestations Neurobehavioral Manifestations Memory Disorders |
Nervous System Diseases |