The Impact of Lorazepam on Cognition in APOE e4 Carriers

Alzheimer's Disease Clinical Trial

Official title:

The Impact of Lorazepam on Cognition in APOE e4 Carriers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586430
• Other study ID #: 929-05
• Secondary ID: 929-05
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• lorazepam
single 2 mg dose of lorazepam
• placebo
single dose of placebo

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Groton Maze Learning Task		baseline, 2.5 hours and 5 hours	No
Secondary	Auditory Verbal Learning Test		baseline, 2.5 hours and 5 hours	No
Secondary	1-back test		baseline, 2.5 hours and 5 hours	No