Alzheimer's DiseaseNCT00586430
The Impact of Lorazepam on Cognition in APOE e4 Carriers
A study testing lorazepam in people with Alzheimer's Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- lorazepam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2007
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- significant medical, psychiatric, or neurological illnesses
- use of benzodiazepines within the previous four weeks
- currently using sedating antihistamines
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
We aim to compare measures of memory and information processing speed at 2.5 hours and 5 hours after the administration of a 2 mg dose of lorazepam or placebo in cognitively normal, 50-65 year old APOE e4 carriers and noncarriers, and determine the differential impact of lorazepam on cognition at each time point. Twenty carriers and 20 noncarriers matched for age, sex, and education will be drawn from a database of persons who have already undergone genotyping for an ongoing study at the Mayo Clinic, excluding people with evidence of depression or cognitive impairment and other medical, neurological or psychiatric conditions. Using a double blind, crossover design, subjects will receive either placebo or a 2 mg dose of lorazepam after baseline testing. Equivalent tests will be repeated 2.5 and 5 hours post challenge. The data analysis will compare APOE e4 carriers to noncarriers.
- Conditions
- Alzheimer's Disease
- Being tested
- lorazepam, placebo
- Keywords
- apolipoprotein E e4, Alzheimer's disease, somnolence, Early detection
- Medical subject headings
- Alzheimer Disease, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorazepamDrug
Also called Ativan
single 2 mg dose of lorazepam
placeboDrug
single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | single 2 mg dose of lorazepam Receives: Drug: lorazepam |
| 2 | Placebo comparator | single dose of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Groton Maze Learning Task
Measured: baseline, 2.5 hours and 5 hours
Secondary outcomes (2)
Auditory Verbal Learning Test
Measured: baseline, 2.5 hours and 5 hours
1-back test
Measured: baseline, 2.5 hours and 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startDec 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Cynthia M Stonnington, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586430
- Sponsor's protocol ID
- 929-05
- Other IDs
- 929-05
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19573495
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lorazepam on Cognition in APOE e4 Carriers
- ClinicalTrials.gov ID
- NCT00586430
- Acronym / sponsor ID
- 929-05
- Conditions
- Alzheimer's Disease
- Keywords
- apolipoprotein E e4, Alzheimer's disease, somnolence, Early detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 4 Jan 2008 (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.
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.
Detailed description
We aim to compare measures of memory and information processing speed at 2.5 hours and 5 hours after the administration of a 2 mg dose of lorazepam or placebo in cognitively normal, 50-65 year old APOE e4 carriers and noncarriers, and determine the differential impact of lorazepam on cognition at each time point. Twenty carriers and 20 noncarriers matched for age, sex, and education will be drawn from a database of persons who have already undergone genotyping for an ongoing study at the Mayo Clinic, excluding people with evidence of depression or cognitive impairment and other medical, neurological or psychiatric conditions. Using a double blind, crossover design, subjects will receive either placebo or a 2 mg dose of lorazepam after baseline testing. Equivalent tests will be repeated 2.5 and 5 hours post challenge. The data analysis will compare APOE e4 carriers to noncarriers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: lorazepamsingle 2 mg dose of lorazepam |
| 2 | Placebo comparator | Drug: placebosingle dose of placebo |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- significant medical, psychiatric, or neurological illnesses
- use of benzodiazepines within the previous four weeks
- currently using sedating antihistamines
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 2 mg dose of lorazepam | Drug | 1 |
| placebosingle dose of placebo | Drug | 2 |
Primary outcome
Groton Maze Learning Task
Time frame: baseline, 2.5 hours and 5 hours
2 secondary outcomes
Auditory Verbal Learning Test
Time frame: baseline, 2.5 hours and 5 hours
1-back test
Time frame: baseline, 2.5 hours and 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 4 Jan 2008.
- Derived from this study: PubMed 19573495Stonnington 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.
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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 M Stonnington, M.D. 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 study testing lorazepam in people with Alzheimer's Disease, 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 5 inclusion and 3 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 4 Jan 2008. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Task (time frame: baseline, 2.5 hours and 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586430, which also lists 1 linked publication.
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 4 Jan 2008; AzTrials last refreshed its copy on 8 Nov 2026.