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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cynthia M. Stonnington, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01780519
First received: January 29, 2013
Last updated: July 28, 2016
Last verified: July 2016
  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 Intervention Phase
Alzheimer's Disease (AD)
Drug: lorazepam
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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.


Enrollment: 57
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
L/VL APOE e3/e4 carrier
long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier
Drug: lorazepam
single dose of 1 mg lorazepam
Other Name: Ativan
L/S APOE e3/e4 carrier
long and short poly - T variants of TOMM40 and APOE e3/e4 carrier
Drug: lorazepam
single dose of 1 mg lorazepam
Other Name: Ativan
S/VL APOE e3/e3 carrier
short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier
Drug: lorazepam
single dose of 1 mg lorazepam
Other Name: Ativan
VL/VL APOE e3/e3 carrier
Very long poly - T variants of TOMM40 and APOE e3/e3 carrier
Drug: lorazepam
single dose of 1 mg lorazepam
Other Name: Ativan
S/S APOE e3/e3 carrier
short poly - T variants of TOMM40 and APOE e3/e3 carrier
Drug: lorazepam
single dose of 1 mg lorazepam
Other Name: Ativan

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780519

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Cynthia Stonnington, MD Mayo Clinic
  More Information

Responsible Party: Cynthia M. Stonnington, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01780519     History of Changes
Other Study ID Numbers: 12-006469 
Study First Received: January 29, 2013
Last Updated: July 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Alzheimer's disease (AD)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016