Normal Elderly PopulationNCT01780896
Relationship Between Vestibular Function and Topographic Memory
An observational study of Normal Elderly Population, run by Biomedical Development Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate visual and nonvisual topographic memory impairment and its relationship to vestibular function in humans. Topographic memory refers to the ability to remember current and past locations in topographic (navigational) space and to make and/or adjust to spatial transformations… Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Normal Elderly Population
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Jun 2013
- Phase
- Observational
- 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Nominally healthy adults between the ages of 70 and 85 yrs who meet inclusion/exclusion criteria. All study participants will be recruited from the San Antonio community.
Who may be able to join
- Males or females of all racial and ethnic groups between the ages of 70 and 85 years of age;
- Montreal Cognitive Assessment (MOCA) (http://www.mocatest.org) score of >24;
- No known history or current evidence of stroke, trauma, psychiatric illness, or other insult to the brain;
- No current use of psychoactive medicine other than caffeine (100 mg/day) or alcohol (1-2 drinks per night);
- Normal sleep (at least an average of 7 hours for four days prior to participation);
- Able and willing to comply with study requirements including following instructions to complete vestibular and neuropsychological testing; and
- Have full understanding of all elements of provide signature and dating of the written informed consent prior to the initiation of procedures specified in protocol.
Who cannot join
- <70 or >85 yrs of age;
- MOCA score of <25;
- History, or current evidence, of stroke, trauma, psychiatric illness, or other insult to the brain;
- Prior history of inner-ear balance problems;
- Current use of psychoactive medicine other than moderate caffeine or alcohol use;
- Acute or chronic sleep deprivation during the week prior to participation (<7 hours/night on average for four nights prior to participation).
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- Other Restrictions:
- No alcohol use on the night before the vestibular testing
- 7 hours minimum sleep the night before vestibular testing
- No eye make-up can be worn on the day of the vestibular test due to possible interference with vestibular-ocular reflex testing apparatus
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ears of Texas, PA
San Antonio, Texas, 78215
Wesley Krueger, MD
Michael Roman, PhD, LSSP
San Antonio, Texas, 78229
Michael Roman, MD
About this study
Official title: The Relationship Between Vestibular Function and Topographic Memory
The purpose of this study is to evaluate visual and nonvisual topographic memory impairment and its relationship to vestibular function in humans. Topographic memory refers to the ability to remember current and past locations in topographic (navigational) space and to make and/or adjust to spatial transformations using such memories. Performance on each of these topographic memory tasks will be compared to performance on a set of comparable nontopographic memory tasks. Topographic impairments represent some of the earliest cognitive deficits observed in Alzheimer's Disease, and the brain areas involved in topographic memory are the first to show degenerative changes.
- Conditions
- Normal Elderly Population
- Keywords
- Topographical Memory, Non-Topographical Memory, Vestibular Function, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine relationship between topographic memory and vestibular function
Measured: 14 days
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 startFeb 2013
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Elderly PopulationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Michael Roman, PhD, LSSD, Ears of Texas, PA
- Responsible party
- Sponsor
- Investigators
- Fred Previc, PhD, Principal investigator, Biomedical Development Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780896
- Sponsor's protocol ID
- 121101-R43TR000645-01
- Other IDs
- R43TR000645
- Status last verified
- Jan 2013
- First submitted
- 29 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vestibular Function and Topographic Memory
- ClinicalTrials.gov ID
- NCT01780896
- Acronym / sponsor ID
- 121101-R43TR000645-01
- Conditions
- Normal Elderly Population
- Keywords
- Topographical Memory, Non-Topographical Memory, Vestibular Function, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Michael Roman, PhD, LSSD, Ears of Texas, PA
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- 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 purpose of this study is to evaluate visual and nonvisual topographic memory impairment and its relationship to vestibular function in humans. Topographic memory refers to the ability to remember current and past locations in topographic (navigational) space and to make and/or adjust to spatial transformations using such memories. Performance on each of these topographic memory tasks will be compared to performance on a set of comparable nontopographic memory tasks. Topographic impairments represent some of the earliest cognitive deficits observed in Alzheimer's Disease, and the brain areas involved in topographic memory are the first to show degenerative changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | – |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Nominally healthy adults between the ages of 70 and 85 yrs who meet inclusion/exclusion criteria. All study participants will be recruited from the San Antonio community.
Key inclusion criteria (7 listed)
- Males or females of all racial and ethnic groups between the ages of 70 and 85 years of age;
- Montreal Cognitive Assessment (MOCA) (http://www.mocatest.org) score of >24;
- No known history or current evidence of stroke, trauma, psychiatric illness, or other insult to the brain;
- No current use of psychoactive medicine other than caffeine (100 mg/day) or alcohol (1-2 drinks per night);
- Normal sleep (at least an average of 7 hours for four days prior to participation);
Key exclusion criteria (10 listed)
- <70 or >85 yrs of age;
- MOCA score of <25;
- History, or current evidence, of stroke, trauma, psychiatric illness, or other insult to the brain;
- Prior history of inner-ear balance problems;
- Current use of psychoactive medicine other than moderate caffeine or alcohol use;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine relationship between topographic memory and vestibular function
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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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.
Fred Previc, PhD principal investigator
Biomedical Development Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Elderly Population, run by Biomedical Development Corporation at 2 sites 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fred Previc, PhD (210-308-0636, fprevic@sbcglobal.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine relationship between topographic memory and vestibular function (time frame: 14 days). 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 1 Feb 2013.