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

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.

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