Mild Cognitive ImpairmentNCT02419183
A Study of a Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR) in Participants With Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 84 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- SAMSTAR and RAVLT
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Chapel Hill, North Carolina
Study site
Durham, North Carolina
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- SAMSTAR, RAVLT
- Keywords
- Mild Cognitive Impairment, Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR), Rey Auditory Verbal Learning Test (RAVLT), Word List Recall (WLR)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMSTAROther
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.
RAVLTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: SAMSTAR; Other: RAVLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 weeks
Secondary outcomes (1)
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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419183
- Sponsor's protocol ID
- CR106702
- Other IDs
- NOPRODALZ0001
- Status last verified
- Jun 2016
- First submitted
- 14 Apr 2015
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02419183
- Acronym / sponsor ID
- CR106702
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | – | Other: SAMSTAR, Other: RAVLTParticipants 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. |
| Sequence B | – | Other: SAMSTAR, Other: RAVLTParticipants will receive an examiner-administered WLR [RAVLT] on Test Day 1 and a computer adminstered WLR [SAMSTAR] on Test Day 2 of the study. |
Who may qualify
- Ages
- 55 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Participant must have normal visual and hearing acuity (corrected or uncorrected) as assessed in the Screening cognitive test (MoCA)
- Screening Criteria:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAMSTARThis 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 | Sequence A, Sequence B |
| RAVLTThis 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 | Sequence A, Sequence B |
Primary outcome
Cognitive Evaluation by Self-administered memory screening test with automated reporting (SAMSTAR)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Assess the feasibility of SAMSTAR
Time frame: Up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Janssen Research & Development, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Evaluation by Self-administered memory screening test with automated reporting (SAMSTAR) (time frame: Up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016; AzTrials last refreshed its copy on 27 Oct 2026.