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

Completed

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02419183

Run by

Janssen Research & Development, LLC

People needed

153

Starts

2015-05-01

Expected to finish

2016-03-01

Last updated by the study team

2016-07-01

Who can join

Age: 55 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

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

You may not qualify if…

• 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

Where it is running

• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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