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The Impact of Lorazepam on Cognition in APOE e4 Carriers
This study has been completed.
Sponsor:
Mayo Clinic
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586430
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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Purpose
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 | Intervention |
|---|---|
| Alzheimer's Disease | Drug: lorazepam Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Screening |
| Official Title: | The Impact of Lorazepam on Cognition in APOE e4 Carriers |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Drug Information available for:
Lorazepam
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Groton Maze Learning Task [ Time Frame: baseline, 2.5 hours and 5 hours ]
Secondary Outcome Measures:
- Auditory Verbal Learning Test [ Time Frame: baseline, 2.5 hours and 5 hours ]
- 1-back test [ Time Frame: baseline, 2.5 hours and 5 hours ]
| Enrollment: | 36 |
| Study Start Date: | December 2005 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 50 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586430
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586430
Locations
| United States, Arizona | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
Sponsors and Collaborators
Mayo Clinic
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Cynthia M Stonnington, M.D. | Mayo Clinic |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cynthia Stonnington, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00586430 History of Changes |
| Other Study ID Numbers: |
929-05 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
Keywords provided by Mayo Clinic:
|
apolipoprotein E e4 Alzheimer's disease somnolence Early detection |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Lorazepam Anticonvulsants Antiemetics 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 |
ClinicalTrials.gov processed this record on July 21, 2017