Clinical trial NCT05438147: Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Mild Cognitive Impairment
Cancer
Keywords: Digital therapeutics
Phone app
Virtual study
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 114
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active Intervention Device vs. Care-as-Usual Control
Primary purpose: BASIC_SCIENCE

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 nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc.

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 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.

Eligibility criteria: Inclusion Criteria:

A participant will be eligible for entry into the study if all the following criteria are met:

1. Age ranges in years: 22-52 for Multiple Sclerosis, 35-65 for Cancer (Breast or Lung), and 45-75 for Mild Cognitive Impairment.
2. Diagnosis of indication under study (Multiple Sclerosis, Cancer - Breast or Lung, Mild Cognitive Impairment)
3. Self-reported cognitive impairment and mood symptoms that began in the context of the primary indication under study.
4. Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.)
5. Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey.
6. Lives in the United States.
7. Has an active email address and is willing and able to receive email messages.
8. 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:

1. Physician-diagnosed insomnia in the Screening Survey.
2. Cognitive impairment/mood symptoms or clinical diagnosis of depression attributed to a condition other than the underlying medical condition.
3. Is currently pregnant or breastfeeding.
4. Substance use disorder within the past 1 year.
5. Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months.
6. Participation in a clinical trial within the last 3 months.
7. Anticipates a lifestyle change or change in current treatment during the study period that could affect cognitive functioning.
8. Visual, dexterity or cognitive deficit so severe that precludes the use of an app.
9. Severe neurological disorders impairing brain function.
10. Psychiatric hospitalization in the past 6 months.

Primary outcomes:
measure: PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF)
timeFrame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Secondary outcomes:
measure: 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
timeFrame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
measure: Global Rating of Change (GRC-Cognition and GRC-Mood)
timeFrame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
measure: Changes in indication-specific measures of Symbol Digit Modalities Test (SDMT) in Multiple Sclerosis (only)
timeFrame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
measure: Changes in indication-specific measures of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) in Cancer (Breast/Lung; only).
timeFrame: Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MDPhD, FAAN
role: STUDY_DIRECTOR
affiliation: Click Therapeutics
name: Jacqueline Lutz, PhD
role: STUDY_DIRECTOR
References: