The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Cynthia M. Stonnington, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01780519
First received: January 29, 2013
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease (AD) |
Drug: lorazepam |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Lorazepam
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- AVLT Long term memory score [ Time Frame: baseline to 5 hours ] [ Designated as safety issue: No ]The AVLT (Rey Auditory Verbal Learning Test), a verbal memory test, is a 15-word list presented over 5 learning trials. After each presentation, the subject immediately repeats as many words as possible, then does so again after 30 minutes, which is the "long-term memory" score. "Percent recall" is long-term memory divided by learning trial 5. The "learning over trials" score reflects the increment in words repeated over the 5 successive learning trials. Six equivalent alternate forms of the AVLT will be randomly assigned to each subject.
- Groton Maze Learning Test (GMLT) score [ Time Frame: baseline to 5 hours ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Ativan
|
|
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 Name: Ativan
|
|
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 Name: Ativan
|
|
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 Name: Ativan
|
|
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 Name: Ativan
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780519
Contacts
| Contact: Jan A Light, LPN | (480) 301-8788 | Light.Jan@mayo.edu |
| Contact: Bruce Henslin | 480-301-8549 | henslin.bruce@mayo.edu |
Locations
| United States, Arizona | |
| Mayo Clinic | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Cynthia Stonnington, MD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Cynthia M. Stonnington, M.D., PI, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01780519 History of Changes |
| Other Study ID Numbers: | 12-006469 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Alzheimer's disease (AD) |
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