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LX6171 High Dose

Phase 2

Age-Related Memory Disorders | Small molecule | Neurology |Lexicon Pharmaceuticals, Inc.|Last Updated: Mar 3, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

LX6171 High Dose · 1 trial · 1 indication

Phase 2 1
NCT00691808Study of LX6171 in Elderly Volunteers With Age Associated Memory ImpairmentAge-Related Memory Disorders
COMPLETED103 Analytics
PHASE2COMPLETED
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Age-Related Memory DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Were Exposed to LX6171
≥28 days
Number of Subjects Reporting at Least One Adverse Event (AE)
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.

Number of Subjects Reporting Adverse Events Leading to Withdrawal
28 days
Treatment Compliance
End of study

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

Secondary Endpoints

Plasma Concentration
Day 28
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
Day 28
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High DoseEXPERIMENTAL -
Low DoseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
LX6171 High DoseDRUGA high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
LX6171 Low DoseDRUGA low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
PlaceboDRUGMatching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
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Eligibility Criteria

Age Range60 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:Netherlands
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Frequently asked questions about LX6171 High Dose

What is LX6171 High Dose used for?

LX6171 High Dose is an investigational small molecule being developed for age-related memory disorders. It was studied in elderly volunteers with age-associated memory impairment. The drug is in Phase 2 clinical development and is not approved by the FDA.

Who makes LX6171 High Dose?

LX6171 High Dose is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker LXRX. The company conducted a Phase 2 clinical trial of the drug in elderly volunteers with age-associated memory impairment.

What phase is LX6171 High Dose in?

LX6171 High Dose is in Phase 2 clinical development. A Phase 2 study of the drug has been completed. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is LX6171 High Dose in?

LX6171 High Dose has one completed clinical trial, identified as NCT00691808. This Phase 2 study, titled 'Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment,' enrolled 103 participants in the Netherlands. The trial was randomized, double-blind, and placebo-controlled.

Is LX6171 High Dose the same as LX6171?

LX6171 High Dose is a specific dosage form of the investigational drug LX6171. The completed Phase 2 trial NCT00691808 studied LX6171 in elderly volunteers with age-associated memory impairment, and the high dose refers to one of the dosage levels evaluated in that study.