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The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms

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ClinicalTrials.gov Identifier: NCT01780519
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Cynthia M. Stonnington, M.D., Mayo Clinic

Study Description
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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
Alzheimer's Disease (AD) Drug: lorazepam Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
Study Start Date : January 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Groton Maze Learning Test (GMLT) score [ Time Frame: 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 :
  1. Auditory Verbal Learning Test (AVLT) Long-term memory score [ Time Frame: baseline to 5 hours ]
    The AVLT assesses verbal memory

  2. Two Back Test (TBK) [ Time Frame: baseline to 5 hours ]
    The TBK measures working memory


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780519


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Cynthia Stonnington, MD Mayo Clinic
More Information
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Responsible Party: Cynthia M. Stonnington, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01780519    
Other Study ID Numbers: 12-006469
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Keywords provided by Cynthia M. Stonnington, M.D., Mayo Clinic:
Alzheimer's disease (AD)
Additional relevant MeSH terms:
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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