Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

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).

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Detailed Description

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Conditions

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Age-Related Memory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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High Dose

Group Type EXPERIMENTAL

LX6171 High Dose

Intervention Type DRUG

A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.

Low Dose

Group Type EXPERIMENTAL

LX6171 Low Dose

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Placebo

Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

Intervention Type DRUG

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)

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No