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CT-100 is a platform that provides an interactive, software based therapeutic component that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc.
CT-100 is a platform that provides an interactive, software based therapeutic component (CT-100-001) that may be used as part of a multimodal treatment in future prescription or non-prescription software-based digital therapeutics (PDT/DTx). CT-100-001 contains a class of Digital Neuro-activation and Modulation (DiNaMo) component. This DiNaMo component targets key neural systems (including, but not limited to, systems related to cognitive control, sensory-, perceptual-, affective-, pain-, attention-, social-, and self-processing) to optimally improve patients' cognitive and mental health. The CT-100-001 DiNaMo component is designed to improve cognitive impairments and mood challenges.
The purpose of the proposed basket study is to evaluate the initial effects of the CT-100-001, a DiNaMo component (the Study App) on cognitive functioning and related outcomes compared to Care-As-Usual across several non-DSM-5 indications. These indications have known high prevalence of cognitive impairments due to the illness and/or treatments. such as in Multiple Sclerosis, Breast or Lung Cancer, and Mild Cognitive Impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis | Active Comparator | Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis |
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| Care-as-Usual control in Patients with Multiple Sclerosis | Sham Comparator | Randomized controlled Study to Evaluate Care-as-Usual control in Patients with Multiple Sclerosis |
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| CT-100 DiNaMo (Study App) in Patients with Breast or Lung Cancer | Active Comparator | Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with with Breast or Lung Cancer |
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| Care-as-Usual control in Patients with Breast or Lung Cancer | Sham Comparator | Randomized Controlled Study to Evaluate Care-as-Usual control in Patients with with Breast or Lung Cancer |
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| CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment | Active Comparator | Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-100 DiNaMo | Other | Active Treatment (Study App) |
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| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF) | Change in cognitive functioning as measured by PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF) in the Study App intervention group compared to a Care-As-Usual control group; 8 items, from minimum of 8 (worst) to maximum of 40 (best) | Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Quality-of-Life (QoL) as measured by the PROMIS-29 in the Study App intervention group compared to a Care-As-Usual control group | To explore changes in patient-reported Quality-of-Life (QoL) as measured by the PROMIS-29 in the Study App intervention group compared to a Care-As-Usual control group; 29 items across mood (2 domains), physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities and cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). |
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Inclusion Criteria:
A participant will be eligible for entry into the study if all the following criteria are met:
Exclusion Criteria:
A participant is excluded from the study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Lakhan, MDPhD, FAAN | Click Therapeutics | Study Director |
| Jacqueline Lutz, PhD | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Active Intervention Device vs. Care-as-Usual Control
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| Care-as-Usual in Patients with Mild Cognitive Impairment | Sham Comparator | Randomized Controlled Study to Evaluate Care-as-Usual in Patients with Mild Cognitive Impairment |
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| Care-as-Usual | Other | Care-As-Usual control |
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| Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21 |
| Global Rating of Change (GRC-Cognition and GRC-Mood) | Treatment impact reported at week 3 as measured by Global Rating of Change (GRC-Cognition and GRC-Mood) in the Study App intervention group compared to a Care-As-Usual control group; -5 (worst), 0 unchanged, 5 (best - recovered) | Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21 |
| Changes in indication-specific measures of Symbol Digit Modalities Test (SDMT) in Multiple Sclerosis (only) | To explore changes in indication-specific measures of Symbol Digit Modalities Test (SDMT) in the Study App intervention group compared to a Care-As-Usual control group in in Multiple Sclerosis. For SDMT, scoring involves summing the number of correct substitutions within the 90 second interval, minimum: 0 (worst), max: 110 (best). | Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21 |
| Changes in indication-specific measures of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) in Cancer (Breast/Lung; only). | To explore changes in indication-specific measures of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) in the Study App intervention group compared to a Care-As-Usual control group in Cancer (Breast/Lung). For FACT-Cog, scoring involves 37-item Likert-scaled questionnaire with responses ranging from 0 to 4 and consisting of four subscales (Perceived Cognitive Impairments, Perceived Cognitive Abilities, Impact on Quality Of Life, Comments From Others). Higher scores are better (better functioning or quality of life): minimum 0 (worst), maximum 4 (best). | Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |