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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
103
A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
Kendle Netherlands
Utrecht, Netherlands
Pharmaceutical Research Associates Group BV
Zuidlaren, Netherlands
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)
An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.
Time frame: 28 days
Number of Subjects Reporting Adverse Events Leading to Withdrawal
Time frame: 28 days
Treatment Compliance
Subjects were considered compliant if they had taken \>70% of possible doses of the study drug.
Time frame: End of study
Plasma Concentration
Time frame: Day 28
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.
Time frame: Day 28
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Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.
Time frame: Day 28
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Time frame: Day 28
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Time frame: Day 28
Change From Baseline in Epworth Sleepiness Scale at Day 28
The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Time frame: Day 28