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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438147
• Other study ID #: CT-100-D-001
• Status: Completed
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: September 6, 2022

Study information

• Verified date: April 2023
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Multiple Sclerosis

Intervention

Other:
• CT-100 DiNaMo
Active Treatment (Study App)
• Care-as-Usual
Care-As-Usual control

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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