The Impact of Lorazepam on Cognition in APOE e4 Carriers
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: lorazepam (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Cynthia M Stonnington, M.D., Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: The Impact of Lorazepam on Cognition in APOE e4 Carriers
Study design: Screening, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment
Primary outcome: Groton Maze Learning Task
Secondary outcome: Auditory Verbal Learning Test1-back test
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.
Eligibility
Minimum age: 50 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mayo Clinic, Scottsdale, Arizona 85259, United States
Additional Information
Starting date: December 2005
Ending date: July 2007
Last updated: December 21, 2007
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