Trial Outcomes & Findings for Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment (NCT NCT00691808)

NCT ID: NCT00691808

Last Updated: 2010-03-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 103 participants
• Primary outcome timeframe: ≥28 days
• Results posted on: 2010-03-03

Participant Flow

The study was performed at 2 centers in the Netherlands, one in Utrecht and one in Zuidlaren. Recruitment began in October of 2007 and the last subject completed the study in October of 2008.

Participant milestones

Measure	High Dose 240 mg LX6171 oral suspension administered once per day	Low Dose 120 mg LX6171 oral suspension administered once per day	Placebo Placebo dosing volume-matched and administered once per day
Overall Study STARTED	35	36	32
Overall Study COMPLETED	35	35	32
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Baseline characteristics by cohort

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day	Total n=103 Participants Total of all reporting groups
Age Continuous	65.97 years STANDARD_DEVIATION 3.48 • n=5 Participants	67.81 years STANDARD_DEVIATION 4.79 • n=7 Participants	67.37 years STANDARD_DEVIATION 4.41 • n=5 Participants	67.05 years STANDARD_DEVIATION 4.30 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	59 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	34 Participants n=5 Participants	36 Participants n=7 Participants	31 Participants n=5 Participants	101 Participants n=4 Participants

PRIMARY outcome

Timeframe: ≥28 days

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Number of Participants Who Were Exposed to LX6171	35 Participants	33 Participants	31 Participants

PRIMARY outcome

Timeframe: 25 to 27 days

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Number of Participants Who Were Exposed to LX6171	0 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 14 to18 days

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Number of Participants Who Were Exposed to LX6171	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 days

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.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Number of Subjects Reporting at Least One Adverse Event (AE)	25 Participants	22 Participants	26 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Number of Subjects Reporting Adverse Events Leading to Withdrawal	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: End of study

Subjects were considered compliant if they had taken >70% of possible doses of the study drug.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Treatment Compliance	100.0 Percentage of Participants Standard Deviation 0	99.80 Percentage of Participants Standard Deviation 0.84	99.89 Percentage of Participants Standard Deviation 0.64

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Plasma Concentration	4670 ng/mL Standard Deviation 1470	2300 ng/mL Standard Deviation 618	0 ng/mL Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28	-1.2 Number of words Standard Deviation 7.6	-1.9 Number of words Standard Deviation 5.6	-1.1 Number of words Standard Deviation 6.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28	-1.5 Number of words Standard Deviation 2.3	-1.7 Number of words Standard Deviation 2.2	-2.3 Number of words Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28	0.9 Units on a scale Standard Deviation 5.9	-2.4 Units on a scale Standard Deviation 6.0	2.5 Units on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28	0.3 Units on a scale Standard Deviation 1.1	0.3 Units on a scale Standard Deviation 1.7	0.7 Units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Dose n=35 Participants 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 Participants 120 mg LX6171 oral suspension administered once per day	Placebo n=32 Participants Placebo dosing volume-matched and administered once per day
Change From Baseline in Epworth Sleepiness Scale at Day 28	-0.9 Units on a scale Standard Deviation 2.0	0 Units on a scale Standard Deviation 2.6	-0.6 Units on a scale Standard Deviation 2.1

Adverse Events

High Dose

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Low Dose

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Dose n=35 participants at risk 240 mg LX6171 oral suspension administered once per day	Low Dose n=36 participants at risk 120 mg LX6171 oral suspension administered once per day	Placebo n=32 participants at risk Placebo dosing volume-matched and administered once per day
Gastrointestinal disorders Abdominal discomfort	2.9% 1/35 • Number of events 1 • 35 days	0.00% 0/36 • 35 days	6.2% 2/32 • Number of events 4 • 35 days
Gastrointestinal disorders Abdominal pain	8.6% 3/35 • Number of events 4 • 35 days	8.3% 3/36 • Number of events 3 • 35 days	15.6% 5/32 • Number of events 5 • 35 days
Gastrointestinal disorders Abdominal pain upper	0.00% 0/35 • 35 days	2.8% 1/36 • Number of events 1 • 35 days	6.2% 2/32 • Number of events 3 • 35 days
Gastrointestinal disorders Diarrhea	8.6% 3/35 • Number of events 3 • 35 days	5.6% 2/36 • Number of events 2 • 35 days	21.9% 7/32 • Number of events 10 • 35 days
Gastrointestinal disorders Nausea	8.6% 3/35 • Number of events 3 • 35 days	5.6% 2/36 • Number of events 2 • 35 days	6.2% 2/32 • Number of events 2 • 35 days
Infections and infestations Rhinitis	2.9% 1/35 • Number of events 1 • 35 days	8.3% 3/36 • Number of events 3 • 35 days	9.4% 3/32 • Number of events 3 • 35 days
Musculoskeletal and connective tissue disorders Back pain	5.7% 2/35 • Number of events 2 • 35 days	0.00% 0/36 • 35 days	9.4% 3/32 • Number of events 3 • 35 days
Musculoskeletal and connective tissue disorders Myalgia	2.9% 1/35 • Number of events 1 • 35 days	0.00% 0/36 • 35 days	6.2% 2/32 • Number of events 3 • 35 days
Nervous system disorders Dizziness	14.3% 5/35 • Number of events 6 • 35 days	13.9% 5/36 • Number of events 5 • 35 days	3.1% 1/32 • Number of events 1 • 35 days
Nervous system disorders Headache	28.6% 10/35 • Number of events 20 • 35 days	13.9% 5/36 • Number of events 8 • 35 days	28.1% 9/32 • Number of events 16 • 35 days
Nervous system disorders Somnolence	8.6% 3/35 • Number of events 3 • 35 days	8.3% 3/36 • Number of events 5 • 35 days	6.2% 2/32 • Number of events 2 • 35 days
Nervous system disorders Early morning awakening	2.9% 1/35 • Number of events 1 • 35 days	5.6% 2/36 • Number of events 2 • 35 days	0.00% 0/32 • 35 days
Nervous system disorders Insomnia	14.3% 5/35 • Number of events 5 • 35 days	5.6% 2/36 • Number of events 3 • 35 days	3.1% 1/32 • Number of events 1 • 35 days
General disorders Fatigue	2.9% 1/35 • Number of events 1 • 35 days	8.3% 3/36 • Number of events 3 • 35 days	3.1% 1/32 • Number of events 1 • 35 days

Additional Information

Joel P. Freiman, MD, MPH - Medical Director, Drug safety

Lexicon Pharmaceuticals, Inc.

Phone: 281-863-3000

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor requires that written permission be given before the investigator can release any data publicly.
• Publication restrictions are in place

Restriction type: OTHER