Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Exploratory Basket Study to Evaluate the Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms in Adult Participants With a Primary Non-DSM-5 Diagnosis

Conditions
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Multiple Sclerosis, Mild Cognitive Impairment, Cancer

Intervention / Treatment
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* Other: CT-100 DiNaMo
* Other: Care-as-Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A participant will be eligible for entry into the study if all the following criteria are met: Age ranges in years: 22-52 for Multiple Sclerosis, 35-65 for Cancer (Breast or Lung), and 45-75 for Mild Cognitive Impairment. Diagnosis of indication under study (Multiple Sclerosis, Cancer - Breast or Lung, Mild Cognitive Impairment) Self-reported cognitive impairment and mood symptoms that began in the context of the primary indication under study. Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.) Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey. Lives in the United States. Has an active email address and is willing and able to receive email messages. Is the sole user of an iPhone or a smartphone with an Android operating system, and with cellular and/or internet access for the duration of the study period. Exclusion Criteria: A participant is excluded from the study if any of the following criteria apply: Physician-diagnosed insomnia in the Screening Survey. Cognitive impairment/mood symptoms or clinical diagnosis of depression attributed to a condition other than the underlying medical condition. Is currently pregnant or breastfeeding. Substance use disorder within the past 1 year. Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months. Participation in a clinical trial within the last 3 months. Anticipates a lifestyle change or change in current treatment during the study period that could affect cognitive functioning. Visual, dexterity or cognitive deficit so severe that precludes the use of an app. Severe neurological disorders impairing brain function. Psychiatric hospitalization in the past 6 months.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active Intervention Device vs. Care-as-Usual Control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis<br>Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis | Other: CT-100 DiNaMo<br>* Active Treatment (Study App)<br>|
| Sham Comparator: Care-as-Usual control in Patients with Multiple Sclerosis<br>Randomized controlled Study to Evaluate Care-as-Usual control in Patients with Multiple Sclerosis | Other: Care-as-Usual<br>* Care-As-Usual control<br>|
| Active Comparator: CT-100 DiNaMo (Study App) in Patients with Breast or Lung Cancer<br>Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with with Breast or Lung Cancer | Other: CT-100 DiNaMo<br>* Active Treatment (Study App)<br>|
| Sham Comparator: Care-as-Usual control in Patients with Breast or Lung Cancer<br>Randomized Controlled Study to Evaluate Care-as-Usual control in Patients with with Breast or Lung Cancer | Other: Care-as-Usual<br>* Care-As-Usual control<br>|
| Active Comparator: CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment<br>Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment | Other: CT-100 DiNaMo<br>* Active Treatment (Study App)<br>|
| Sham Comparator: Care-as-Usual in Patients with Mild Cognitive Impairment<br>Randomized Controlled Study to Evaluate Care-as-Usual in Patients with Mild Cognitive Impairment | Other: Care-as-Usual<br>* Care-As-Usual control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital therapeutics, Phone app, Virtual study