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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01780896
Other study ID # 121101-R43TR000645-01
Secondary ID R43TR000645
Status Not yet recruiting
Phase N/A
First received January 29, 2013
Last updated January 30, 2013
Start date February 2013
Est. completion date June 2013

Study information

Verified date January 2013
Source Biomedical Development Corporation
Contact Fred Previc, PhD
Phone 210-308-0636
Email fprevic@sbcglobal.net
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 70 Years to 85 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- <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).

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Ears of Texas, PA San Antonio Texas
United States Michael Roman, PhD, LSSP San Antonio Texas

Sponsors (4)

Lead Sponsor Collaborator
Biomedical Development Corporation Ears of Texas, PA, Michael Roman, PhD, LSSD, National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine relationship between topographic memory and vestibular function 14 days No