NCT00586430

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
Last Updated

January 4, 2008

Status Verified

December 1, 2007

Enrollment Period

1.6 years

First QC Date

December 21, 2007

Last Update Submit

December 21, 2007

Conditions

Alzheimer's Disease

Keywords

apolipoprotein E e4Alzheimer's diseasesomnolenceEarly detection

Outcome Measures

Primary Outcomes (1)

  • Groton Maze Learning Task

    baseline, 2.5 hours and 5 hours

Secondary Outcomes (2)

  • Auditory Verbal Learning Test

    baseline, 2.5 hours and 5 hours

  • 1-back test

    baseline, 2.5 hours and 5 hours

Study Arms (2)

1

ACTIVE COMPARATOR

single 2 mg dose of lorazepam

Drug: lorazepam

2

PLACEBO COMPARATOR

single dose of placebo

Drug: placebo

Interventions

lorazepamDRUG

single 2 mg dose of lorazepam

Also known as: Ativan
1
placeboDRUG

single dose of placebo

2

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

  • Stonnington CM, Snyder PJ, Hentz JG, Reiman EM, Caselli RJ. Double-blind crossover study of the cognitive effects of lorazepam in healthy apolipoprotein E (APOE)-epsilon4 carriers. J Clin Psychiatry. 2009 Oct;70(10):1379-84. doi: 10.4088/JCP.08m04593. Epub 2009 Jun 30.

    PMID: 19573495DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseSleepiness

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Cynthia M Stonnington, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

December 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 4, 2008

Record last verified: 2007-12

Locations

US(1)