The Impact of Lorazepam on Cognition in APOE e4 Carriers
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 (Subject, Caregiver, Investigator) Primary Purpose: Screening |
| Official Title: | The Impact of Lorazepam on Cognition in APOE e4 Carriers |
- Groton Maze Learning Task [ Time Frame: baseline, 2.5 hours and 5 hours ] [ Designated as safety issue: No ]
- Auditory Verbal Learning Test [ Time Frame: baseline, 2.5 hours and 5 hours ] [ Designated as safety issue: No ]
- 1-back test [ Time Frame: baseline, 2.5 hours and 5 hours ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided by Mayo Clinic
Additional 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, 929-05 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
| Health Authority: | United States: Food and Drug Administration |
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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Lorazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013