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

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.

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.