Alzheimer's Disease (AD)Phase 1NCT01780519
The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
A Phase 1 study testing lorazepam in people with Alzheimer's Disease (AD), run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- lorazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About 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.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- lorazepam
- Keywords
- Alzheimer's disease (AD)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorazepamDrug
Also called Ativan
single dose of 1 mg lorazepam
| Study group | Role | What they receive |
|---|---|---|
| L/VL APOE e3/e4 carrier | Other | long and very long poly - T variants of TOMM40 and APOE e3/e4 carrier Receives: Drug: lorazepam |
| L/S APOE e3/e4 carrier | Other | long and short poly - T variants of TOMM40 and APOE e3/e4 carrier Receives: Drug: lorazepam |
| S/VL APOE e3/e3 carrier | Other | short and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier Receives: Drug: lorazepam |
| VL/VL APOE e3/e3 carrier | Other | Very long poly - T variants of TOMM40 and APOE e3/e3 carrier Receives: Drug: lorazepam |
| S/S APOE e3/e3 carrier | Other | short poly - T variants of TOMM40 and APOE e3/e3 carrier Receives: Drug: lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Groton Maze Learning Test (GMLT) score
The GMLT assesses visuospatial working memory, error monitoring, information processing speed, and short-term delayed recall for a complex hidden maze. Subjects are familiarized with the task during two untimed practice tests, and once the tester is confident that the subject understands the rules and can move easily around the grid, the timed test is administered. In each of the 5 successive trials of the GMLT exam, the subject is asked to learn to navigate his or her way around a 28-step maze that is hidden beneath a 10 x 10 grid of squares on the computer touch screen. For each trial, the time to completion, number of correct moves, number of wrong moves, and the number of perseverative errors are recorded.
Measured: baseline to 5 hours
Secondary outcomes (2)
Auditory Verbal Learning Test (AVLT) Long-term memory score
The AVLT assesses verbal memory
Measured: baseline to 5 hours
Two Back Test (TBK)
The TBK measures working memory
Measured: baseline to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia M. Stonnington, M.D., Mayo Clinic
- Investigators
- Cynthia Stonnington, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780519
- Sponsor's protocol ID
- 12-006469
- Status last verified
- Nov 2016
- First submitted
- 29 Jan 2013
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
- ClinicalTrials.gov ID
- NCT01780519
- Acronym / sponsor ID
- 12-006469
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- Alzheimer's disease (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| L/VL APOE e3/e4 carrier | Other | Drug: lorazepamlong and very long poly - T variants of TOMM40 and APOE e3/e4 carrier |
| L/S APOE e3/e4 carrier | Other | Drug: lorazepamlong and short poly - T variants of TOMM40 and APOE e3/e4 carrier |
| S/VL APOE e3/e3 carrier | Other | Drug: lorazepamshort and Very long poly - T variants of TOMM40 and APOE e3/e3 carrier |
| VL/VL APOE e3/e3 carrier | Other | Drug: lorazepamVery long poly - T variants of TOMM40 and APOE e3/e3 carrier |
| S/S APOE e3/e3 carrier | Other | Drug: lorazepamshort poly - T variants of TOMM40 and APOE e3/e3 carrier |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorazepamAlso: Ativansingle dose of 1 mg lorazepam | Drug | L/S APOE e3/e4 carrier, L/VL APOE e3/e4 carrier, S/S APOE e3/e3 carrier, S/VL APOE e3/e3 carrier, VL/VL APOE e3/e3 carrier |
Primary outcome
Groton Maze Learning Test (GMLT) score
Time frame: baseline to 5 hours
The GMLT assesses visuospatial working memory, error monitoring, information processing speed, and short-term delayed recall for a complex hidden maze. Subjects are familiarized with the task during two untimed practice tests, and once the tester is confident that the subject understands the rules and can move easily around the grid, the timed test is administered. In each of the 5 successive trials of the GMLT exam, the subject is asked to learn to navigate his or her way around a 28-step maze that is hidden beneath a 10 x 10 grid of squares on the computer touch screen. For each trial, the time to completion, number of correct moves, number of wrong moves, and the number of perseverative errors are recorded.
2 secondary outcomes
Auditory Verbal Learning Test (AVLT) Long-term memory score
Time frame: baseline to 5 hours
Two Back Test (TBK)
Time frame: baseline to 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Stonnington, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lorazepam in people with Alzheimer's Disease (AD), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Groton Maze Learning Test (GMLT) score (time frame: baseline to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.