Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
114 participants in 6 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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