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

NCT01780519 | Completed Phase 1

• 1 other identifier: 12-006469
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease (AD)

Keywords

Alzheimer's disease (AD)

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 5 hours

Secondary Outcomes (2)

• Auditory Verbal Learning Test (AVLT) Long-term memory score

  baseline to 5 hours

• Two Back Test (TBK)

  baseline to 5 hours

Study Arms (5)

L/VL APOE e3/e4 carrier

OTHER

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

Drug: lorazepam

L/S APOE e3/e4 carrier

OTHER

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

Drug: lorazepam

S/VL APOE e3/e3 carrier

OTHER

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

Drug: lorazepam

VL/VL APOE e3/e3 carrier

OTHER

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

Drug: lorazepam

S/S APOE e3/e3 carrier

OTHER

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

Drug: lorazepam

Interventions

lorazepam DRUG

single dose of 1 mg lorazepam

Also known as: Ativan

L/S APOE e3/e4 carrier; L/VL APOE e3/e4 carrier; S/S APOE e3/e3 carrier; S/VL APOE e3/e3 carrier; VL/VL APOE e3/e3 carrier

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cynthia Stonnington, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

US (1)