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The Impact of Lorazepam on Cognition in APOE e4 Carriers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586430
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

We expect the results of this pilot study to justify a larger study that follows people to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam (a widely used anti-anxiety medication) could predict an individual's risk of developing AD. We plan to compare cognitively normal people who possess a common gene that increases risk for AD— the apolipoprotein E (APOE) e4 allele—to individuals without this gene. We hypothesize that a single 2 mg dose of lorazepam will cause more cognitive impairment in carriers of the APOE e4 allele than in noncarriers, and that the carriers will recover more slowly from these impairments than noncarriers.


Condition Intervention
Alzheimer's Disease
Drug: lorazepam
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Screening
Official Title: The Impact of Lorazepam on Cognition in APOE e4 Carriers

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Groton Maze Learning Task [ Time Frame: baseline, 2.5 hours and 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Auditory Verbal Learning Test [ Time Frame: baseline, 2.5 hours and 5 hours ] [ Designated as safety issue: No ]
  • 1-back test [ Time Frame: baseline, 2.5 hours and 5 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
single 2 mg dose of lorazepam
Drug: lorazepam
single 2 mg dose of lorazepam
Other Name: Ativan
Placebo Comparator: 2
single dose of placebo
Drug: placebo
single dose of placebo

Detailed Description:

We aim to compare measures of memory and information processing speed at 2.5 hours and 5 hours after the administration of a 2 mg dose of lorazepam or placebo in cognitively normal, 50-65 year old APOE e4 carriers and noncarriers, and determine the differential impact of lorazepam on cognition at each time point. Twenty carriers and 20 noncarriers matched for age, sex, and education will be drawn from a database of persons who have already undergone genotyping for an ongoing study at the Mayo Clinic, excluding people with evidence of depression or cognitive impairment and other medical, neurological or psychiatric conditions. Using a double blind, crossover design, subjects will receive either placebo or a 2 mg dose of lorazepam after baseline testing. Equivalent tests will be repeated 2.5 and 5 hours post challenge. The data analysis will compare APOE e4 carriers to noncarriers.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a score of at least 28 on the MMSE
  • a score of less than 10 points on the HAM-D-17
  • age 50-65
  • genotype APOE e3/e4 or APOE e4 non-carriers
  • cognitively normal

Exclusion Criteria:

  • significant medical, psychiatric, or neurological illnesses
  • use of benzodiazepines within the previous four weeks
  • currently using sedating antihistamines
  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: NCT00586430

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

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia Stonnington, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586430     History of Changes
Other Study ID Numbers: 929-05, 929-05
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
apolipoprotein E e4
Alzheimer's disease
somnolence
Early detection

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

ClinicalTrials.gov processed this record on November 27, 2014