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Completed

NCT Number: NCT00586430

The Impact of Lorazepam on Cognition in APOE e4 Carriers

We expect the results of this pilot study to justify a larger study that follows people to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam (a widely used anti-anxiety medication) could predict an individual's risk of developing AD. We plan to compare cognitively normal people who possess a common gene that increases risk for AD- the apolipoprotein E (APOE) e4 allele-to individuals without this gene. We hypothesize that a single 2 mg dose of lorazepam will cause more cognitive impairment in carriers of the APOE e4 allele than in noncarriers, and that the carriers will recover more slowly from these impairments than noncarriers.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness Tauopathies

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

About this study

We aim to compare measures of memory and information processing speed at 2.5 hours and 5 hours after the administration of a 2 mg dose of lorazepam or placebo in cognitively normal, 50-65 year old APOE e4 carriers and noncarriers, and determine the differential impact of lorazepam on cognition at each time point. Twenty carriers and 20 noncarriers matched for age, sex, and education will be drawn from a database of persons who have already undergone genotyping for an ongoing study at the Mayo Clinic, excluding people with evidence of depression or cognitive impairment and other medical, neurological or psychiatric conditions. Using a double blind, crossover design, subjects will receive either placebo or a 2 mg dose of lorazepam after baseline testing. Equivalent tests will be repeated 2.5 and 5 hours post challenge. The data analysis will compare APOE e4 carriers to noncarriers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a score of at least 28 on the MMSE
  • a score of less than 10 points on the HAM-D-17
  • age 50-65
  • genotype APOE e3/e4 or APOE e4 non-carriers
  • cognitively normal

Exclusion criteria

  • significant medical, psychiatric, or neurological illnesses
  • use of benzodiazepines within the previous four weeks
  • currently using sedating antihistamines

Treatment and study plan

Lorazepam

Drug

single 2 mg dose of lorazepam

Other names: Ativan

Placebo

Drug

single dose of placebo

Primary outcomes

  1. Groton Maze Learning Task

    Time frame: baseline, 2.5 hours and 5 hours

Secondary outcomes

  1. Auditory Verbal Learning Test

    Time frame: baseline, 2.5 hours and 5 hours

  2. 1-back test

    Time frame: baseline, 2.5 hours and 5 hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 4, 2008
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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