A Study of a Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR) in Participants With Mild Cognitive Impairment

NCT02419183 | Completed

• 2 other identifiers: CR106702NOPRODALZ0001
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the psychometric properties of a Self-administered Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory Verbal Learning Test (RAVLT) in normal control (NC) participants and participants with Mild Cognitive Impairment (MCI) against a standard version of the RAVLT test, administered by an examiner under the same conditions.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR); Rey Auditory Verbal Learning Test (RAVLT); Word List Recall (WLR)

Outcome Measures

Primary Outcomes (2)

• Cognitive Evaluation by Self-administered memory screening test with automated reporting (SAMSTAR)

  The memory test will include a list of 15 words presented one at a time through the iPad (on screen and aloud). After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible.

  Up to 3 weeks

• Cognitive Evaluation by Rey Auditory Verbal Learning Test (RAVLT)

  The memory test will include a list of 15 words presented one at a time verbally by the examiner. After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible.

  Up to 3 weeks

Secondary Outcomes (1)

• Assess the feasibility of SAMSTAR

  Up to 3 weeks

Study Arms (2)

Sequence A

Participants will receive a computer administered Word List Recall (WLR) \[SAMSTAR\] on Test Day 1 and an examiner addminstered WLR \[RAVLT\] on Test Day 2 of the study.

Other: SAMSTAR; Other: RAVLT

Sequence B

Participants will receive an examiner-administered WLR \[RAVLT\] on Test Day 1 and a computer adminstered WLR \[SAMSTAR\] on Test Day 2 of the study.

Other: SAMSTAR; Other: RAVLT

Interventions

SAMSTAR OTHER

This is a non-interventional study based on computer-administered WLR (SAMSTAR) test and examiner-administered WLR (RAVLT) test to investigate whether the performance of participants is equivalent.

Sequence A; Sequence B

RAVLT OTHER

This is a non-interventional study based on computer-administered WLR (SAMSTAR) test and examiner-administered WLR (RAVLT) test to investigate whether the performance of participants is equivalent.

Sequence A; Sequence B

Eligibility Criteria

• Age: 55 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female adult normal control (NC) participants and participants with Mild Cognitive Impairment (MCI), aged 55 to 84 years receiving healthcare in primary care and/or neurology practice settings.

You may qualify if:

• Participant must have normal visual and hearing acuity (corrected or uncorrected) as assessed in the Screening cognitive test (MoCA)
• Screening Criteria:

You may not qualify if:

• Participant must be English-speaking and able to understand and follow the examiner/trial instructions
• Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
• Participant has an acute or chronic medical condition (eg, Alzheimer's disease \[AD\] or depression) that would interfere with the participant's ability to complete either memory test assessment or comply with other study requirements
• Participant has an acute or chronic psychiatric condition that would interfere with the participant's ability to complete either memory test assessment or comply with other study requirements
• Participant has any acute or chronic neurological conditions (eg, stroke, epilepsy, Parkinson's disease)
• Participant has any sensory, motor or speech impairment that would interfere with the participants' ability to complete memory testing that relies on speech recognition
• Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (2)