|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00586430 |
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: | Screening, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment |
| Official Title: | The Impact of Lorazepam on Cognition in APOE e4 Carriers |
| 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 |
|---|---|
|
1: Active Comparator
single 2 mg dose of lorazepam
|
Drug: lorazepam
single 2 mg dose of lorazepam
|
|
2: Placebo Comparator
single dose of placebo
|
Drug: placebo
single dose of placebo
|
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:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Mayo Clinic ( Cynthia Stonnington, M.D. ) |
| Study ID Numbers: | 929-05, 929-05 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00586430 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
apolipoprotein E e4 Alzheimer's disease somnolence Early detection |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Antiemetics Neurodegenerative Diseases Brain Diseases Lorazepam Mental Disorders Therapeutic Uses Hypnotics and Sedatives Dementia Tranquilizing Agents |
Nervous System Diseases Alzheimer Disease Gastrointestinal Agents Central Nervous System Depressants Central Nervous System Diseases Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Tauopathies Central Nervous System Agents Anticonvulsants |
