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

A Randomized Cross-over, Controlled Feasibility, and Validation Study of a Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR) in Subjects With Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: SAMSTAR; Other: RAVLT

Detailed Description

This is a single-center (when only one hospital or medical school team work on a medical research study), randomized (participants are assigned to treatment by a chance), crossover (participants may receive different treatments sequentially during the trial) study. The study consists of a Screening Phase (Day -3 up to and including Day 1), Test Phase (Test Day 1 and Test Day 2 [within 7 to 14 days following Test Day 1]) and an optional follow-up visit within 7 days after the last study-related activity for participants who experienced an adverse event that had not resolved by the end of the last test visit.The NC and MCI participants will initially either undergo a standard version of the RAVLT test or the SAMSTAR version of the RAVLT test on Test Day 1 or on the same day as screening, with follow-up testing using the other test using a crossover design to be conducted within 1 to 2 weeks at the same venue (Test Day 2). There will be a 7-to 14-day memory washout period between the test periods. No investigational medicinal product will be administered. The maximum study duration for a participant will not exceed 3 weeks.

• Study Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
    • Durham, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

• Screening Criteria:

  1. NC participants: meet inclusion/exclusion criteria, Dementia Screening Interview (8- item) (AD8) score 0-1, MoCA score 28 or higher (education-adjusted)
  2. MCI participants: meet inclusion/exclusion criteria, AD8 score 2 or higher, MoCA score 24 to 27 (education-adjusted)
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other: RAVLT; 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 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; 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.; Other: RAVLT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the feasibility of SAMSTAR	The feasibility of using a SAMSTAR approach to cognitive screening will be evaluated by meeting target enrollment criteria and by survey data from participants and clinical staff about their experience and attitudes regarding cognitive screening as executed in this study.	Up to 3 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR); Rey Auditory Verbal Learning Test (RAVLT); Word List Recall (WLR)
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CR106702; NOPRODALZ0001 (Other Identifier: Janssen Research & Development, LLC)