NCT01780896

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

January 29, 2013

Last Update Submit

January 30, 2013

Conditions

Normal Elderly Population

Keywords

Topographical MemoryNon-Topographical MemoryVestibular FunctionAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Determine relationship between topographic memory and vestibular function

    14 days

Study Arms (1)

Study Group

Eligibility Criteria

Age70 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • \<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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ears of Texas, PA

San Antonio, Texas, 78215, United States

Location

Michael Roman, PhD, LSSP

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Fred Previc, PhD

    Biomedical Development Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fred Previc, PhD

CONTACT

210-308-0636fprevic@sbcglobal.net

Karl McCloskey

CONTACT

(361) 442-7491mccloskey@biodevcorp.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 31, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(2)