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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cancer; Mild Cognitive Impairment
• Intervention / Treatment: Other: CT-100 DiNaMo; Other: Care-as-Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Investigators: Study Director: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Digital therapeutics; Phone app; Virtual study
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurocognitive Disorders; Cognition Disorders; Multiple Sclerosis; Cognitive Dysfunction
• Other Study ID Numbers: CT-100-D-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No