Status:
COMPLETED
Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms
Lead Sponsor:
Click Therapeutics, Inc.
Conditions:
Multiple Sclerosis
Mild Cognitive Impairment
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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 nonprescriptio...
Detailed 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 softw...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2022
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05438147
Start Date
May 13 2022
End Date
September 6 2022
Last Update
April 26 2023
Active Locations (1)
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1
Click Therapeutics
New York, New York, United States, 10013