Cognitive Function
Conditions
Brief summary
Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.
Detailed description
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.
Interventions
DEVICEDCTclock
Cognitive Test
Sponsors
Linus Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* 55-95 years old
Exclusion criteria
* Ineligible for written informed consent * Impairment of the writing hand that precludes ability to perform the study tasks * Impaired manual dexterity in the writing hand * Impaired vision in both eyes * Under the influence of recreational drugs or alcohol at the time of the visit. * Current or recent participation in a clinical trial that includes the use of a drug or intervention to alter cognitive function. * Recent (within the last 6 months) cognitive testing with a Clock Drawing Test. * Visit 2 Only- Self-reported change (addition or discontinuation) of the following medications between visit 1 and visit 2; Timolol (eye drop), Benadryl, beta blockers, steroids or over the counter medications for sleep (PM varieties).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment | 5 weeks | Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE. |
| Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | 5 weeks | Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-Related and Non-Device Related Adverse Events | 5 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| DCTclock-pen First DCTclock-pen followed by DCTclock-tablet
DCTclock: Cognitive Test | 97 |
| DCTclock-tablet First DCTclock-tablet followed by DCTclock-pen
DCTclock: Cognitive Test | 98 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Assessment | Adverse Event | 2 | 0 |
| Second Assessment | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | DCTclock-pen First | DCTclock-tablet First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 40 Participants | 85 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 58 Participants | 110 Participants |
| Dementia Medication Usage Aricept (Donepezil) Currently | 4 Participants | 4 Participants | 8 Participants |
| Dementia Medication Usage Aricept (Donepezil) Never | 91 Participants | 93 Participants | 184 Participants |
| Dementia Medication Usage Aricept (Donepezil) Previously | 2 Participants | 1 Participants | 3 Participants |
| Dementia Medication Usage Axona Currently | 0 Participants | 0 Participants | 0 Participants |
| Dementia Medication Usage Axona Never | 97 Participants | 98 Participants | 195 Participants |
| Dementia Medication Usage Axona Previously | 0 Participants | 0 Participants | 0 Participants |
| Dementia Medication Usage Exelon (Rivastigmine) Currently | 2 Participants | 0 Participants | 2 Participants |
| Dementia Medication Usage Exelon (Rivastigmine) Never | 95 Participants | 98 Participants | 193 Participants |
| Dementia Medication Usage Exelon (Rivastigmine) Previously | 0 Participants | 0 Participants | 0 Participants |
| Dementia Medication Usage Namenda (Mematine) Currently | 5 Participants | 2 Participants | 7 Participants |
| Dementia Medication Usage Namenda (Mematine) Never | 92 Participants | 95 Participants | 187 Participants |
| Dementia Medication Usage Namenda (Mematine) Previously | 0 Participants | 1 Participants | 1 Participants |
| Dementia Medication Usage Razadyne (Galantamine) Currently | 0 Participants | 0 Participants | 0 Participants |
| Dementia Medication Usage Razadyne (Galantamine) Never | 97 Participants | 98 Participants | 195 Participants |
| Dementia Medication Usage Razadyne (Galantamine) Previously | 0 Participants | 0 Participants | 0 Participants |
| Education College Degree or Higher | 40 Participants | 38 Participants | 78 Participants |
| Education High School Degree | 16 Participants | 24 Participants | 40 Participants |
| Education Less than High School | 6 Participants | 6 Participants | 12 Participants |
| Education Some College | 35 Participants | 30 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 19 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 79 Participants | 157 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton-Veale Contrast Sensitivity Score Binocular | 11.4 units on a scale STANDARD_DEVIATION 1.1 | 11.6 units on a scale STANDARD_DEVIATION 1.1 | 11.5 units on a scale STANDARD_DEVIATION 1.1 |
| Hamilton-Veale Contrast Sensitivity Score Left | 10.6 units on a scale STANDARD_DEVIATION 1.8 | 10.7 units on a scale STANDARD_DEVIATION 2.4 | 10.7 units on a scale STANDARD_DEVIATION 2.1 |
| Hamilton-Veale Contrast Sensitivity Score Right | 10.6 units on a scale STANDARD_DEVIATION 1.7 | 10.6 units on a scale STANDARD_DEVIATION 2.5 | 10.6 units on a scale STANDARD_DEVIATION 2.1 |
| Handedness Ambidextrous | 0 Participants | 1 Participants | 1 Participants |
| Handedness Left | 9 Participants | 10 Participants | 19 Participants |
| Handedness Right | 88 Participants | 87 Participants | 175 Participants |
| Medical History Brain Tumor Currently | 0 Participants | 1 Participants | 1 Participants |
| Medical History Brain Tumor Never | 96 Participants | 97 Participants | 193 Participants |
| Medical History Brain Tumor Previously | 1 Participants | 0 Participants | 1 Participants |
| Medical History Dementia (any type) Currently | 3 Participants | 1 Participants | 4 Participants |
| Medical History Dementia (any type) Never | 94 Participants | 96 Participants | 190 Participants |
| Medical History Dementia (any type) Previously | 0 Participants | 1 Participants | 1 Participants |
| Medical History Diabetes Currently | 32 Participants | 28 Participants | 60 Participants |
| Medical History Diabetes Never | 64 Participants | 70 Participants | 134 Participants |
| Medical History Diabetes Previously | 1 Participants | 0 Participants | 1 Participants |
| Medical History Liver or Kidney Disease Currently | 5 Participants | 2 Participants | 7 Participants |
| Medical History Liver or Kidney Disease Never | 92 Participants | 95 Participants | 187 Participants |
| Medical History Liver or Kidney Disease Previously | 0 Participants | 1 Participants | 1 Participants |
| Medical History Mild Cognitive Impairment (MCI) Currently | 0 Participants | 2 Participants | 2 Participants |
| Medical History Mild Cognitive Impairment (MCI) Never | 97 Participants | 96 Participants | 193 Participants |
| Medical History Mild Cognitive Impairment (MCI) Previously | 0 Participants | 0 Participants | 0 Participants |
| Medical History Parkinson's Disease and Related Conditions Currently | 1 Participants | 0 Participants | 1 Participants |
| Medical History Parkinson's Disease and Related Conditions Never | 96 Participants | 98 Participants | 194 Participants |
| Medical History Parkinson's Disease and Related Conditions Previously | 0 Participants | 0 Participants | 0 Participants |
| Medical History Psychiatric Disorder (including Anxiety/Depression) Currently | 14 Participants | 20 Participants | 34 Participants |
| Medical History Psychiatric Disorder (including Anxiety/Depression) Never | 79 Participants | 75 Participants | 154 Participants |
| Medical History Psychiatric Disorder (including Anxiety/Depression) Previously | 4 Participants | 3 Participants | 7 Participants |
| Medical History Sleep Apnea Currently | 9 Participants | 16 Participants | 25 Participants |
| Medical History Sleep Apnea Never | 87 Participants | 80 Participants | 167 Participants |
| Medical History Sleep Apnea Previously | 1 Participants | 2 Participants | 3 Participants |
| Medical History Stroke or TIA Currently | 1 Participants | 0 Participants | 1 Participants |
| Medical History Stroke or TIA Never | 91 Participants | 93 Participants | 184 Participants |
| Medical History Stroke or TIA Previously | 5 Participants | 5 Participants | 10 Participants |
| Medical History Traumatic brain injury (with loss of consciousness) Currently | 0 Participants | 1 Participants | 1 Participants |
| Medical History Traumatic brain injury (with loss of consciousness) Never | 92 Participants | 93 Participants | 185 Participants |
| Medical History Traumatic brain injury (with loss of consciousness) Previously | 5 Participants | 4 Participants | 9 Participants |
| Medical History Tremor Currently | 1 Participants | 1 Participants | 2 Participants |
| Medical History Tremor Never | 95 Participants | 96 Participants | 191 Participants |
| Medical History Tremor Previously | 1 Participants | 1 Participants | 2 Participants |
| Mini-Mental State Exam (MMSE) Score Attention and Calculation (WORLD) | 4.6 units on a scale STANDARD_DEVIATION 0.9 | 4.7 units on a scale STANDARD_DEVIATION 0.7 | 4.7 units on a scale STANDARD_DEVIATION 0.8 |
| Mini-Mental State Exam (MMSE) Score Comprehension | 3.0 units on a scale STANDARD_DEVIATION 0.1 | 2.9 units on a scale STANDARD_DEVIATION 0.3 | 3.0 units on a scale STANDARD_DEVIATION 0.2 |
| Mini-Mental State Exam (MMSE) Score Drawing | 0.8 units on a scale STANDARD_DEVIATION 0.4 | 0.8 units on a scale STANDARD_DEVIATION 0.4 | 0.8 units on a scale STANDARD_DEVIATION 0.4 |
| Mini-Mental State Exam (MMSE) Score Naming | 2.0 units on a scale STANDARD_DEVIATION 0.1 | 2.0 units on a scale STANDARD_DEVIATION 0 | 2.0 units on a scale STANDARD_DEVIATION 0.1 |
| Mini-Mental State Exam (MMSE) Score Orientation to Place | 4.4 units on a scale STANDARD_DEVIATION 0.7 | 4.3 units on a scale STANDARD_DEVIATION 0.8 | 4.4 units on a scale STANDARD_DEVIATION 0.7 |
| Mini-Mental State Exam (MMSE) Score Orientation to Time | 4.8 units on a scale STANDARD_DEVIATION 0.5 | 4.7 units on a scale STANDARD_DEVIATION 0.8 | 4.7 units on a scale STANDARD_DEVIATION 0.7 |
| Mini-Mental State Exam (MMSE) Score Reading | 1.0 units on a scale STANDARD_DEVIATION 0.1 | 1.0 units on a scale STANDARD_DEVIATION 0 | 1.0 units on a scale STANDARD_DEVIATION 0.1 |
| Mini-Mental State Exam (MMSE) Score Recall | 2.6 units on a scale STANDARD_DEVIATION 0.7 | 2.7 units on a scale STANDARD_DEVIATION 0.7 | 2.6 units on a scale STANDARD_DEVIATION 0.7 |
| Mini-Mental State Exam (MMSE) Score Registration | 3.0 units on a scale STANDARD_DEVIATION 0 | 3.0 units on a scale STANDARD_DEVIATION 0.1 | 3.0 units on a scale STANDARD_DEVIATION 0.1 |
| Mini-Mental State Exam (MMSE) Score Repetition | 0.8 units on a scale STANDARD_DEVIATION 0.4 | 0.8 units on a scale STANDARD_DEVIATION 0.4 | 0.8 units on a scale STANDARD_DEVIATION 0.4 |
| Mini-Mental State Exam (MMSE) Score Total | 27.9 units on a scale STANDARD_DEVIATION 2.2 | 27.9 units on a scale STANDARD_DEVIATION 2.4 | 27.9 units on a scale STANDARD_DEVIATION 2.3 |
| Mini-Mental State Exam (MMSE) Score Writing | 1.0 units on a scale STANDARD_DEVIATION 0.1 | 1.0 units on a scale STANDARD_DEVIATION 0.1 | 1.0 units on a scale STANDARD_DEVIATION 0.1 |
| Purdue Pegboard Score Both Hands | 10.7 units on a scale STANDARD_DEVIATION 5 | 11.7 units on a scale STANDARD_DEVIATION 5.2 | 11.2 units on a scale STANDARD_DEVIATION 5.1 |
| Purdue Pegboard Score Left | 10.3 units on a scale STANDARD_DEVIATION 2.1 | 10.4 units on a scale STANDARD_DEVIATION 2.2 | 10.4 units on a scale STANDARD_DEVIATION 2.1 |
| Purdue Pegboard Score Right | 11.0 units on a scale STANDARD_DEVIATION 2.4 | 11.3 units on a scale STANDARD_DEVIATION 2.5 | 11.1 units on a scale STANDARD_DEVIATION 2.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 24 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 69 Participants | 71 Participants | 140 Participants |
| Sex: Female, Male Female | 56 Participants | 62 Participants | 118 Participants |
| Sex: Female, Male Male | 41 Participants | 36 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 98 | 0 / 97 | 0 / 98 | 1 / 97 | 0 / 98 |
| other Total, other adverse events | 0 / 97 | 0 / 98 | 0 / 97 | 1 / 98 | 4 / 97 | 1 / 98 |
| serious Total, serious adverse events | 0 / 97 | 0 / 98 | 0 / 97 | 0 / 98 | 3 / 97 | 0 / 98 |
Outcome results
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.
Time frame: 5 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DCTClock-pen | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment | 0.16 Cohen's Kappa Coefficient |
| DCTClock-tablet | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment | 0.23 Cohen's Kappa Coefficient |
90% CI: [-0.05, 0.19]
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.
Time frame: 5 weeks
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DCTClock-pen | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | Pearson Correlation | 0.31 correlation coefficient |
| DCTClock-pen | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | Spearman Correlation | 0.29 correlation coefficient |
| DCTClock-tablet | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | Pearson Correlation | 0.37 correlation coefficient |
| DCTClock-tablet | Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) | Spearman Correlation | 0.36 correlation coefficient |
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.
Time frame: 5 weeks
Population: All participants who passed screening and were enrolled in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 1 | Device-Related Adverse Event | 0 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 1 | Other Adverse Event | 0 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 1 | No Adverse Event | 97 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | Between Visits | Device-Related Adverse Event | 0 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | Between Visits | Other Adverse Event | 7 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | Between Visits | No Adverse Event | 90 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 2 | Device-Related Adverse Event | 0 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 2 | Other Adverse Event | 0 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 2 | No Adverse Event | 97 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | Overall | Device-Related Adverse Event | 0 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | Overall | Other Adverse Event | 7 Participants |
| DCTClock-pen | Number of Participants With Device-Related and Non-Device Related Adverse Events | Overall | No Adverse Event | 90 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | Overall | Other Adverse Event | 2 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 1 | Device-Related Adverse Event | 0 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 2 | Device-Related Adverse Event | 0 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 1 | Other Adverse Event | 0 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | Overall | Device-Related Adverse Event | 0 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 1 | No Adverse Event | 98 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 2 | Other Adverse Event | 1 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | Between Visits | Device-Related Adverse Event | 0 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | Overall | No Adverse Event | 96 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | Between Visits | Other Adverse Event | 1 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | During Visit 2 | No Adverse Event | 97 Participants |
| DCTClock-tablet | Number of Participants With Device-Related and Non-Device Related Adverse Events | Between Visits | No Adverse Event | 97 Participants |