Clinical Trial: Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:
Sponsor: Lexicon Pharmaceuticals

Current Primary Outcome:

  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: ≥28 days ]
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: 25 to 27 days ]
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: 14 to18 days ]
  • Number of Subjects Reporting at Least One Adverse Event (AE) [ Time Frame: 28 days ]
  • Number of Subjects Reporting Adverse Events Leading to Withdrawal [ Time Frame: 28 days ]
  • Treatment Compliance [ Time Frame: End of study ]


Original Primary Outcome: 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. ]

Current Secondary Outcome:

  • Plasma Concentration [ Time Frame: Day 28 ]
  • Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in Pittsburgh Sleep Quality Index at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in Epworth Sleepiness Scale at Day 28 [ Time Frame: Day 28 ]


Original Secondary Outcome:

  • Plasma Concentration [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ]
  • Cognitive assessment [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ]


Information By: Lexicon Pharmaceuticals

Dates:
Date Received: June 2, 2008
Date Started: February 2008
Date Completion:
Last Updated: February 17, 2010
Last Verified: February 2010