The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
Study Details
Study Description
Brief Summary
The investigators' goal is to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam, can predict whether or not an individual is at risk for developing Alzheimer's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: L/VL APOE e3/e4 carrier long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier |
Drug: lorazepam
single dose of 1 mg lorazepam
Other Names:
|
| Other: L/S APOE e3/e4 carrier long and short poly - T variants of TOMM40 and APOE e3/e4 carrier |
Drug: lorazepam
single dose of 1 mg lorazepam
Other Names:
|
| Other: S/VL APOE e3/e3 carrier short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier |
Drug: lorazepam
single dose of 1 mg lorazepam
Other Names:
|
| Other: VL/VL APOE e3/e3 carrier Very long poly - T variants of TOMM40 and APOE e3/e3 carrier |
Drug: lorazepam
single dose of 1 mg lorazepam
Other Names:
|
| Other: S/S APOE e3/e3 carrier short poly - T variants of TOMM40 and APOE e3/e3 carrier |
Drug: lorazepam
single dose of 1 mg lorazepam
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Groton Maze Learning Test (GMLT) score [baseline to 5 hours]
The GMLT assesses visuospatial working memory, error monitoring, information processing speed, and short-term delayed recall for a complex hidden maze. Subjects are familiarized with the task during two untimed practice tests, and once the tester is confident that the subject understands the rules and can move easily around the grid, the timed test is administered. In each of the 5 successive trials of the GMLT exam, the subject is asked to learn to navigate his or her way around a 28-step maze that is hidden beneath a 10 x 10 grid of squares on the computer touch screen. For each trial, the time to completion, number of correct moves, number of wrong moves, and the number of perseverative errors are recorded.
Secondary Outcome Measures
- Auditory Verbal Learning Test (AVLT) Long-term memory score [baseline to 5 hours]
The AVLT assesses verbal memory
- Two Back Test (TBK) [baseline to 5 hours]
The TBK measures working memory
Eligibility Criteria
Criteria
Inclusion criteria:
-
Mini-Mental State Examination (MMSE) score of 28-30
-
Hamilton Depression Rating Scale score of less than 10
-
participants in longitudinal study of aging and have a TOMM40 genotype of S/S, VL/VL, S/VL, L/S or L/VL.
Exclusion criteria:
-
Alzheimer's Disease or Mild Cognitive Impairment
-
any significant medical, psychiatric, and neurological illnesses, e.g., impaired liver or kidney function, prior stroke, traumatic brain injury, memory impairment, cognitive impairment, parkinsonism, a lifetime history of schizophrenia, bipolar disorder, a psychoactive substance use disorder, or current major depression.
-
known allergy to benzodiazepines
-
current use (within the previous four weeks) of benzodiazepines or other medications known to interact with lorazepam, current use of sedating antihistamines, or current use of stimulant medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Cynthia Stonnington, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-006469