Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Age-Related Memory Disorders Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691808
• Other study ID #: LX6171.1-201-AAMI
• Secondary ID: LX6171.201
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2008
• Last updated: February 17, 2010
• Start date: February 2008

Study information

• Verified date: February 2010
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Memory Disorders
• Memory Disorders

Intervention

Drug:
• LX6171 High Dose
A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
• LX6171 Low Dose
A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
• Placebo
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

Locations

Country	Name	City	State
Netherlands	Kendle Netherlands	Utrecht
Netherlands	Pharmaceutical Research Associates Group BV	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Were Exposed to LX6171		=28 days	No
Primary	Number of Participants Who Were Exposed to LX6171		25 to 27 days	No
Primary	Number of Participants Who Were Exposed to LX6171		14 to18 days	No
Primary	Number of Subjects Reporting at Least One Adverse Event (AE)		28 days	No
Primary	Number of Subjects Reporting Adverse Events Leading to Withdrawal		28 days	No
Primary	Treatment Compliance		End of study	No
Secondary	Plasma Concentration		Day 28	No
Secondary	Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28		Day 28	No
Secondary	Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28		Day 28	No
Secondary	Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28		Day 28	No
Secondary	Change From Baseline in Pittsburgh Sleep Quality Index at Day 28		Day 28	No
Secondary	Change From Baseline in Epworth Sleepiness Scale at Day 28		Day 28	No