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| ID | Type | Description | Link |
|---|---|---|---|
| LX6171.201 |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Experimental |
| |
| Low Dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX6171 High Dose | Drug | A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Exposed to LX6171 | ≥28 days | |
| Number of Participants Who Were Exposed to LX6171 | 25 to 27 days | |
| Number of Participants Who Were Exposed to LX6171 | 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. | 28 days |
| Number of Subjects Reporting Adverse Events Leading to Withdrawal | 28 days | |
| Treatment Compliance | Subjects were considered compliant if they had taken >70% of possible doses of the study drug. | End of study |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip M. Brown, M.D., J.D. | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendle Netherlands | Utrecht | 3584 | Netherlands | |||
| Pharmaceutical Research Associates Group BV |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | 240 mg LX6171 oral suspension administered once per day |
| FG001 | Low Dose | 120 mg LX6171 oral suspension administered once per day |
| FG002 | Placebo | Placebo dosing volume-matched and administered once per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | 240 mg LX6171 oral suspension administered once per day |
| BG001 | Low Dose | 120 mg LX6171 oral suspension administered once per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 28 |
|
35 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | 240 mg LX6171 oral suspension administered once per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel P. Freiman, MD, MPH - Medical Director, Drug safety | Lexicon Pharmaceuticals, Inc. | 281-863-3000 |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| LX6171 Low Dose | Drug | A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. |
|
| Placebo | Drug | Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time. |
|
| Day 28 |
| 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. | 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. | 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. | 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. | Day 28 |
| Zuidlaren |
| 9470 |
| Netherlands |
| BG002 | Placebo | Placebo dosing volume-matched and administered once per day |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units | Counts |
|---|
| Participants |
|
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| Primary | Number of Participants Who Were Exposed to LX6171 | Posted | Number | Participants | ≥28 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of words | Day 28 |
|
|
|
| Primary | Number of Participants Who Were Exposed to LX6171 | Posted | Number | Participants | 25 to 27 days |
|
|
|
| Primary | Number of Participants Who Were Exposed to LX6171 | Posted | Number | Participants | 14 to18 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of words | Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 |
|
|
|
| Primary | 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. | Posted | Number | Participants | 28 days |
|
|
|
| Primary | Number of Subjects Reporting Adverse Events Leading to Withdrawal | Posted | Number | Participants | 28 days |
|
|
|
| Primary | Treatment Compliance | Subjects were considered compliant if they had taken >70% of possible doses of the study drug. | Posted | Mean | Standard Deviation | Percentage of Participants | End of study |
|
|
|
| 0 |
| 35 |
| 25 |
| 35 |
| EG001 | Low Dose | 120 mg LX6171 oral suspension administered once per day | 0 | 36 | 22 | 36 |
| EG002 | Placebo | Placebo dosing volume-matched and administered once per day | 0 | 32 | 26 | 32 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Early morning awakening | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
The sponsor requires that written permission be given before the investigator can release any data publicly.
| D013568 | Pathological Conditions, Signs and Symptoms |