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

Primary Purpose

Alzheimer's Disease (AD)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lorazepam
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease (AD) focused on measuring Alzheimer's disease (AD)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

L/VL APOE e3/e4 carrier

L/S APOE e3/e4 carrier

S/VL APOE e3/e3 carrier

VL/VL APOE e3/e3 carrier

S/S APOE e3/e3 carrier

Arm Description

long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier

long and short poly - T variants of TOMM40 and APOE e3/e4 carrier

short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier

Very long poly - T variants of TOMM40 and APOE e3/e3 carrier

short poly - T variants of TOMM40 and APOE e3/e3 carrier

Outcomes

Primary Outcome Measures

Groton Maze Learning Test (GMLT) score
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
The AVLT assesses verbal memory
Two Back Test (TBK)
The TBK measures working memory

Full Information

First Posted
January 29, 2013
Last Updated
November 9, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01780519
Brief Title
The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
Official Title
The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD)
Keywords
Alzheimer's disease (AD)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L/VL APOE e3/e4 carrier
Arm Type
Other
Arm Description
long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier
Arm Title
L/S APOE e3/e4 carrier
Arm Type
Other
Arm Description
long and short poly - T variants of TOMM40 and APOE e3/e4 carrier
Arm Title
S/VL APOE e3/e3 carrier
Arm Type
Other
Arm Description
short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier
Arm Title
VL/VL APOE e3/e3 carrier
Arm Type
Other
Arm Description
Very long poly - T variants of TOMM40 and APOE e3/e3 carrier
Arm Title
S/S APOE e3/e3 carrier
Arm Type
Other
Arm Description
short poly - T variants of TOMM40 and APOE e3/e3 carrier
Intervention Type
Drug
Intervention Name(s)
lorazepam
Other Intervention Name(s)
Ativan
Intervention Description
single dose of 1 mg lorazepam
Primary Outcome Measure Information:
Title
Groton Maze Learning Test (GMLT) score
Description
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.
Time Frame
baseline to 5 hours
Secondary Outcome Measure Information:
Title
Auditory Verbal Learning Test (AVLT) Long-term memory score
Description
The AVLT assesses verbal memory
Time Frame
baseline to 5 hours
Title
Two Back Test (TBK)
Description
The TBK measures working memory
Time Frame
baseline to 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Stonnington, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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