Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Age-Related Memory Disorders

Intervention / Treatment
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* Drug: LX6171 High Dose
* Drug: LX6171 Low Dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 60-80 years old. Complaints of memory loss in everyday life Non-smokers or very light smokers (no more than 10 cigarettes/day) Negative urine screen for drugs of abuse Ability to provide written informed consent Exclusion Criteria: History or evidence of any disease, disorder or injury that could cause cognitive deterioration. Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers Clinically significant abnormality on electrocardiogram History of alcoholism or drug dependence Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose<br> | Drug: LX6171 High Dose<br>* A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.<br>|
| Experimental: Low Dose<br> | Drug: LX6171 Low Dose<br>* A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |