Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.
Randomized crossover trial consisting of two test visits separated by a washout period of 3 to 5 weeks. Subjects are randomized into two equal groups. Group 1 receives the digital pen (DCTclock-pen) version of the test at the first visit, with the tablet version (DCTclock-tablet) given at the second visit; Group 2 receives DCTclock-tablet at the first visit, followed by DCTclock-pen at the second visit. At Visit 1 (day 0), eligibility is assessed and a version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests and reference standard tests are also administered. At visit 2 (day 21-35), eligibility is assessed and the alternate version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests is also administered, together with reference standard tests. Equivalence of DCTclock-pen and DCTclock-tablet will be tested. Linus Platform test data will also be collected to develop novel measures of cognitive and motor function and assess their accuracy in detecting impairment, construct validity, and test-retest reliability.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCTclock-pen first | Experimental | DCTclock-pen followed by DCTclock-tablet |
|
| DCTclock-tablet first | Experimental | DCTclock-tablet followed by DCTclock-pen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCTclock | Device | Cognitive Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment | Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE. | 5 weeks |
| Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device-Related and Non-Device Related Adverse Events | Number of serious device-related adverse events. See adverse events section for full reporting of adverse events, including both device-related and non-device related. | 5 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pascual-Leone, MD | Linus Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clincloud Research | Maitland | Florida | 32751 | United States | ||
| Clinilabs |
Not provided
Not provided
Not provided
Not provided
Not provided
Screening for inclusion criteria was conducted at the first study session after enrollment and prior to randomization. Of 200 enrolled participants, 195 met inclusion criteria and were randomized to groups.
Participants were recruited by referral from neurology clinics at 2 study sites. The first participant was enrolled in December 2020, and the last participant was enrolled in May 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DCTclock-pen First | DCTclock-pen followed by DCTclock-tablet DCTclock: Cognitive Test |
| FG001 | DCTclock-tablet First | DCTclock-tablet followed by DCTclock-pen DCTclock: Cognitive Test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Assessment |
| |||||||||||||
| Second Assessment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DCTclock-pen First | DCTclock-pen followed by DCTclock-tablet DCTclock: Cognitive Test |
| BG001 | DCTclock-tablet First | DCTclock-tablet followed by DCTclock-pen DCTclock: Cognitive Test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment | Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE. | Analysis includes only assessments from participants who: (1) completed both assessment sessions; and (2) produced clocks from both assessments which could be analyzed to give a valid score. Of participants who completed both sessions, 170 of 187 produced two analyzable clocks and were included in analysis (84 of 92 in the pen-first group, and 86 of 95 in the tablet-first group). | Posted | Number | 90% Confidence Interval | Cohen's Kappa Coefficient | 5 weeks | Assessments | Assessments |
|
Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DCTclock-pen First, DCTclock-pen Visit | The DCTclock-pen visit for participants who were assessed with the DCTclock-pen in the first visit, and DCTclock-tablet in the second visit (i.e., Visit 1). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye infection | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean Tobyne | Linus Health | (617) 433-1777 | stobyne@linus.health |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2023 | Dec 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2023 | Dec 12, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Eatontown |
| New Jersey |
| 07724 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Handedness | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Dementia Medication Usage | Count of Participants | Participants |
|
| Mini-Mental State Exam (MMSE) Score | The Mini-Mental State Examination (MMSE) Score is an assessment of cognitive impairment, consisting of a standardized set of tasks. MMSE scores range 0-30, with lower scores indicating greater impairment. The total score is the sum of subscales (ranges in parentheses): Orientation to Time (0-5), Orientation to Place (0-5), Registration (0-3), Attention and Calculation (0-5), Recall (0-3), Naming (0-2), Repetition (0-1), Comprehension (0-3), Reading (0-1), Writing (0-1), Drawing (0-1). | Mean | Standard Deviation | units on a scale |
|
| Hamilton-Veale Contrast Sensitivity Score | The Hamilton-Veale Contrast Sensitivity Score is an assessment of visual sensitivity to contrast. It is measured with a standardized chart presenting a grid of letters with varying contrast relative to a white background. It is assessed separately for the left and right eyes, and for both eyes together (binocular). Scores range 0-16, with a higher score indicating greater sensitivity and an ability to detect lower contrast. | Mean | Standard Deviation | units on a scale |
|
| Purdue Pegboard Score | The Purdue Pegboard Test is an assessment of manual dexterity and motor coordination. The score (ranging 0-25) is the number of pegs a subject is able to place in a grooved board within a time limit. A higher score (more pegs) indicates greater dexterity. The assessment is performed separately for each hand, and for both hands together. | Mean | Standard Deviation | units on a scale |
|
| Medical History | # of participants reporting history of relevant conditions | Count of Participants | Participants |
|
| OG001 | DCTClock-tablet | Assessments with the DCTClock-tablet format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet. Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded. |
|
|
|
| Secondary | Number of Participants With Device-Related and Non-Device Related Adverse Events | Number of serious device-related adverse events. See adverse events section for full reporting of adverse events, including both device-related and non-device related. | All participants who passed screening and were enrolled in the study. | Posted | Count of Participants | Participants | 5 weeks |
|
|
|
| Primary | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE. | Analysis includes only assessments from participants who: (1) completed both assessment sessions; and (2) produced clocks from both assessments which could be analyzed to give a valid score. Of participants who completed both sessions, 170 of 187 produced two analyzable clocks and were included in analysis (84 of 92 in the pen-first group, and 86 of 95 in the tablet-first group). | Posted | Number | 90% Confidence Interval | correlation coefficient | 5 weeks | Assessments | Assessments |
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | DCTclock-tablet First, DCTclock-tablet Visit | The DCTclock-tablet visit for participants who were assessed with the DCTclock-tablet in the first visit, and DCTclock-pen in the second visit (i.e., Visit 1). | 0 | 98 | 0 | 98 | 0 | 98 |
| EG002 | DCTclock-pen First, DCTclock-tablet Visit | The DCTclock-tablet visit for participants who were assessed with the DCTclock-pen at the first visit, and the DCTclock-tablet second visit (i.e., Visit 2). | 0 | 97 | 0 | 97 | 0 | 97 |
| EG003 | DCTclock-tablet First, DCTclock-pen Visit | The DCTclock-pen visit for participants who were assessed with the DCTclock-tablet at the first visit, and the DCTclock-pen at the second visit (i.e., Visit 2). | 0 | 98 | 0 | 98 | 1 | 98 |
| EG004 | DCTclock-pen First, Between Visits | Captures any reported events that occurred between the two study visits, for participants who were assessed with the DCTclock-pen at the first visit, and the DCTclock-tablet at the second visit. | 1 | 97 | 3 | 97 | 4 | 97 |
| EG005 | DCTclock-tablet First, Between Visits | Captures any reported events that occurred between the two study visits, for participants who were assessed with the DCTclock-tablet at the first visit, and the DCTclock-pen at the second visit. | 0 | 98 | 0 | 98 | 1 | 98 |
| Death | General disorders | Systematic Assessment | Unknown cause; details not provided by next of kin; incident occurred between visits and was unrelated to study procedures |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Reported as "shortness of breath" |
|
| Syncope | Cardiac disorders | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Systematic Assessment | worsening of existing condition |
|
| Covid Vaccine Side Effects | Injury, poisoning and procedural complications | Systematic Assessment | self-reported, detail not specified |
|
| Vertigo | General disorders | Systematic Assessment | Reported as "dizziness" |
|
| Fracture of Bone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| Never |
|
| No Adverse Event |
|
| Between Visits |
|
| During Visit 2 |
|
| Overall |
|