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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Alzheimer's Disease (AD)
Intervention	Drug: lorazepam
Phase	Phase 1
Sponsor	Mayo Clinic
Responsible Party	Mayo Clinic
ClinicalTrials.gov Identifier	NCT01780519
First Received	January 29, 2013
Last Updated	January 30, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 29, 2013
Last Updated Date	January 30, 2013
Start Date	January 2013
Estimated Primary Completion Date	January 2014
Current Primary Outcome Measures	AVLT Long term memory score [Time Frame: baseline to 5 hours] [Designated as safety issue: No]The AVLT (Rey Auditory Verbal Learning Test), a verbal memory test, is a 15-word list presented over 5 learning trials. After each presentation, the subject immediately repeats as many words as possible, then does so again after 30 minutes, which is the "long-term memory" score. "Percent recall" is long-term memory divided by learning trial 5. The "learning over trials" score reflects the increment in words repeated over the 5 successive learning trials. Six equivalent alternate forms of the AVLT will be randomly assigned to each subject. Groton Maze Learning Test (GMLT) score [Time Frame: baseline to 5 hours] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

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
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 Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Alzheimer's Disease (AD)
Intervention	Drug: lorazepam single dose of 1 mg lorazepam Other Names: Ativan
Study Arm (s)	Other: L/VL APOE e3/e4 carrier long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier Other: L/S APOE e3/e4 carrier long and short poly - T variants of TOMM40 and APOE e3/e4 carrier Other: S/VL APOE e3/e3 carrier short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier Other: VL/VL APOE e3/e3 carrier Very long poly - T variants of TOMM40 and APOE e3/e3 carrier Other: S/S APOE e3/e3 carrier short poly - T variants of TOMM40 and APOE e3/e3 carrier

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	75
Estimated Completion Date	January 2014
Estimated Primary Completion Date	January 2014
Eligibility Criteria	Inclusion criteria: - 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
Gender	Both
Ages	50 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Jan A Light, LPN (480) 301-8788 Light.Jan@mayo.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01780519
Other Study ID Numbers	12-006469
Has Data Monitoring Committee	No
Information Provided By	Mayo Clinic
Study Sponsor	Mayo Clinic
Collaborators	Not Provided
Investigators	Principal Investigator: Cynthia Stonnington, MD Mayo Clinic
Verification Date	January 2013

Locations[ + expand ][ + ]