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Clinical Trials/NCT01780519
NCT01780519
Completed
Phase 1

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

Mayo Clinic1 site in 1 country57 target enrollmentJanuary 2013
Interventionslorazepam

Overview

Phase
Phase 1
Intervention
lorazepam
Conditions
Alzheimer's Disease (AD)
Sponsor
Mayo Clinic
Enrollment
57
Locations
1
Primary Endpoint
Groton Maze Learning Test (GMLT) score
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cynthia M. Stonnington, M.D.

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

L/VL APOE e3/e4 carrier

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

Intervention: lorazepam

L/S APOE e3/e4 carrier

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

Intervention: lorazepam

S/VL APOE e3/e3 carrier

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

Intervention: lorazepam

VL/VL APOE e3/e3 carrier

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

Intervention: lorazepam

S/S APOE e3/e3 carrier

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

Intervention: lorazepam

Outcomes

Primary Outcomes

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 Outcomes

  • Auditory Verbal Learning Test (AVLT) Long-term memory score(baseline to 5 hours)
  • Two Back Test (TBK)(baseline to 5 hours)

Study Sites (1)

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