MedDataX Logo

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

NCT ID: NCT01780519

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease (AD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alzheimer's disease (AD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

L/VL APOE e3/e4 carrier

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

Group Type OTHER

lorazepam

Intervention Type DRUG

single dose of 1 mg lorazepam

L/S APOE e3/e4 carrier

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

Group Type OTHER

lorazepam

Intervention Type DRUG

single dose of 1 mg lorazepam

S/VL APOE e3/e3 carrier

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

Group Type OTHER

lorazepam

Intervention Type DRUG

single dose of 1 mg lorazepam

VL/VL APOE e3/e3 carrier

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

Group Type OTHER

lorazepam

Intervention Type DRUG

single dose of 1 mg lorazepam

S/S APOE e3/e3 carrier

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

Group Type OTHER

lorazepam

Intervention Type DRUG

single dose of 1 mg lorazepam

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lorazepam

single dose of 1 mg lorazepam

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ativan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cynthia M. Stonnington, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cynthia Stonnington, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-006469

Identifier Type: -

Identifier Source: org_study_id