Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment

NCT ID: NCT01220674

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-15
• Study Completion Date: 2012-10-31

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.

Detailed Description

The investigators are developing a computer-based neuropsychological assessment tool to help primary care physicians detect neurological and psychiatric disorders. To confirm the tool's efficacy, the investigators will first test the prototype against established tests. The investigators propose to collect preliminary data on a limited group of subjects and age-matched controls. Collecting data on a limited group of subjects provides early insight into 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. With this information, the investigators can make adjustments to the tool if needed and collect additional data on revised versions of the tool. The data will be used to establish the validity, reliability and sensitivity of the tool to generate consistent and accurate scores. The investigators will initially focus on a limited age range (age fifty-five to seventy-five) and limited set of diseases (early dementias or mild cognitive impairment) to reduce variability within the patient and control groups and to gain more statistical power with a smaller group of subjects.

Conditions

Cognitive Impairment

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: OTHER

Study Groups

community dwelling older adults, normal controls

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

cognitive testing

Intervention Type: OTHER

computer-based cognitive assessment

community dwelling older adults, mild cognitive impairment

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

cognitive testing

Intervention Type: OTHER

computer-based cognitive assessment

Interventions

cognitive testing

computer-based cognitive assessment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

San Mateo Medical Center

OTHER

Sponsor Role: collaborator

VA Northern California Health Care System

FED

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Bonasera, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0491-10-FB

Identifier Type: -

Identifier Source: org_study_id