Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR), Rey Auditory Verbal Learning Test (RAVLT), Word List Recall (WLR)
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.
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.
Interventions
OTHERSAMSTAR
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.
OTHERRAVLT
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.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 84 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Evaluation by Self-administered memory screening test with automated reporting (SAMSTAR) | Up to 3 weeks | 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. |
| Cognitive Evaluation by Rey Auditory Verbal Learning Test (RAVLT) | Up to 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the feasibility of SAMSTAR | Up to 3 weeks | 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. |
Countries
United States
Outcome results
None listed