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

Phase 1

Completed

• Conditions: Alzheimer's Disease (AD)
• Interventions: Drug: lorazepam

• Registration Number: NCT01780519
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-01-31
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L/VL APOE e3/e4 carrier	lorazepam	long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier
L/S APOE e3/e4 carrier	lorazepam	long and short poly - T variants of TOMM40 and APOE e3/e4 carrier
S/S APOE e3/e3 carrier	lorazepam	short poly - T variants of TOMM40 and APOE e3/e3 carrier
S/VL APOE e3/e3 carrier	lorazepam	short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier
VL/VL APOE e3/e3 carrier	lorazepam	Very long poly - T variants of TOMM40 and APOE e3/e3 carrier

Primary Outcome Measures

Name	Time	Method
Groton Maze Learning Test (GMLT) score	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

Name	Time	Method
Two Back Test (TBK)	baseline to 5 hours	The TBK measures working memory
Auditory Verbal Learning Test (AVLT) Long-term memory score	baseline to 5 hours	The AVLT assesses verbal memory

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States