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Alzheimer's Disease (AD) | The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms

Alzheimer's Disease (AD) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Alzheimer's Disease (AD)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:lorazepamsingle dose of 1 mg lorazepam

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

L/S APOE e3/e4 carrierlong and short poly - T variants of TOMM40 and APOE e3/e4 carrier

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

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

S/S APOE e3/e3 carriershort poly - T variants of TOMM40 and APOE e3/e3 carrier

Study Status

Completed

Start Date: January 2013

Completed Date: September 2016

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Groton Maze Learning Test (GMLT) score

Secondary Outcome: Auditory Verbal Learning Test (AVLT) Long-term memory score

Study sponsors, principal investigator, and references

Principal Investigator: Cynthia Stonnington, MD

Lead Sponsor: Mayo Clinic

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01780519

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