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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease (AD)

Treatments: Drug: lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT01780519

12-006469

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 5 patient groups

L/VL APOE e3/e4 carrier

Other group

Description:

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

Treatment:

Drug: lorazepam

L/S APOE e3/e4 carrier

Other group

Description:

long and short poly - T variants of TOMM40 and APOE e3/e4 carrier

Treatment:

Drug: lorazepam

S/VL APOE e3/e3 carrier

Other group

Description:

short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier

Treatment:

Drug: lorazepam

VL/VL APOE e3/e3 carrier

Other group

Description:

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

Treatment:

Drug: lorazepam

S/S APOE e3/e3 carrier

Other group

Description:

short poly - T variants of TOMM40 and APOE e3/e3 carrier

Treatment:

Drug: lorazepam