Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Age-Related Memory Disorders

Treatments: Drug: LX6171 High Dose; Drug: LX6171 Low Dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00691808

LX6171.201

LX6171.1-201-AAMI

Details and patient eligibility

About

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).

Enrollment: 103 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

103 participants in 3 patient groups, including a placebo group

High Dose

Experimental group

Treatment:

Drug: LX6171 High Dose

Low Dose

Experimental group

Treatment:

Drug: LX6171 Low Dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo