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The Impact of Lorazepam on Cognition in APOE e4 Carriers

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ClinicalTrials.gov Identifier: NCT00586430
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : January 4, 2008
National Institute of Mental Health (NIMH)
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: lorazepam Drug: placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: The Impact of Lorazepam on Cognition in APOE e4 Carriers
Study Start Date : December 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

Arm Intervention/treatment
Active Comparator: 1
single 2 mg dose of lorazepam
Drug: lorazepam
single 2 mg dose of lorazepam
Other Name: Ativan

Placebo Comparator: 2
single dose of placebo
Drug: placebo
single dose of placebo

Primary Outcome Measures :
  1. Groton Maze Learning Task [ Time Frame: baseline, 2.5 hours and 5 hours ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586430

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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
National Institute of Mental Health (NIMH)
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Principal Investigator: Cynthia M Stonnington, M.D. Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cynthia Stonnington, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586430    
Other Study ID Numbers: 929-05
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: December 2007
Keywords provided by Mayo Clinic:
apolipoprotein E e4
Alzheimer's disease
Early detection
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action