The Impact of Lorazepam on Cognition in APOE e4 Carriers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

single 2 mg dose of lorazepam

Group Type ACTIVE_COMPARATOR

lorazepam

Intervention Type DRUG

single 2 mg dose of lorazepam

2

single dose of placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single dose of placebo

Interventions

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lorazepam

single 2 mg dose of lorazepam

Intervention Type DRUG

placebo

single dose of placebo

Intervention Type DRUG

Other Intervention Names

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Ativan

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes