NCT01220674

Brief Summary

A computer-based neuropsychological assessment tool is being developed to help primary care physicians detect neurological and psychiatric disorders. The first version will be tested against current tests to confirm the tool's effectiveness. Data will be collected on how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. Adjustments can then be made to the assessment tool, if needed. The initial participants will be age fifty-five to seventy-five with early dementias or mild cognitive impairment to reduce variability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

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

October 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2012

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

October 12, 2010

Last Update Submit

September 12, 2023

Conditions

Keywords

neuropsychological assessmentcognitive impairmentcomputer-aided diagnostic tool

Study Arms (2)

community dwelling older adults, normal controls

men and women 55 years of age or older who are cognitively intact.

Other: cognitive testing

community dwelling older adults, mild cognitive impairment

men and women 55 years of age or older who have minimal cognitive decline (MMSE 20-24).

Other: cognitive testing

Interventions

computer-based cognitive assessment

community dwelling older adults, mild cognitive impairmentcommunity dwelling older adults, normal controls

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-dwelling adults without significant cognitive impairment

You may qualify if:

  • Any subject with mild impairment from who has already undergone or will soon undergo a full neuropsychological evaluation.
  • Subjects with Clinical Dementia Rating Scale CDR of 0.5-1.0 and Mini-Mental Score 20-26 (or MOCA equivalent, borderline/mild dementia) will be eligible for this group.

You may not qualify if:

  • Subjects whose impairment is severe enough to limit their ability to perform the computer-based tasks and/or to provide consent.
  • Subjects with history of learning disabilities or mental illness including major depression, bipolar disorder, anxiety disorders, and addiction are excluded because these problems can affect cognitive performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Stephen J Bonasera, MD, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 14, 2010

Study Start

December 15, 2010

Primary Completion

October 31, 2012

Study Completion

October 31, 2012

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations