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

November 9, 2016 updated by: Cynthia M. Stonnington, M.D., Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Ativan
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:
  • Ativan
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:
  • Ativan
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:
  • Ativan
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:
  • Ativan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory Verbal Learning Test (AVLT) Long-term memory score
Time Frame: baseline to 5 hours
The AVLT assesses verbal memory
baseline to 5 hours
Two Back Test (TBK)
Time Frame: baseline to 5 hours
The TBK measures working memory
baseline to 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (ESTIMATE)

January 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-006469

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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