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

Alzheimer's Disease (AD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780519
• Other study ID #: 12-006469
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2013
• Last updated: November 9, 2016
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)

Intervention

Drug:
• lorazepam
single dose of 1 mg lorazepam

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Auditory Verbal Learning Test (AVLT) Long-term memory score	The AVLT assesses verbal memory	baseline to 5 hours	No
Secondary	Two Back Test (TBK)	The TBK measures working memory	baseline to 5 hours	No