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

Primary Purpose

Multiple Sclerosis, Mild Cognitive Impairment, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT-100 DiNaMo
Care-as-Usual
Sponsored by
Click Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring Digital therapeutics, Phone app, Virtual study

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Click Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis

Care-as-Usual control in Patients with Multiple Sclerosis

CT-100 DiNaMo (Study App) in Patients with Breast or Lung Cancer

Care-as-Usual control in Patients with Breast or Lung Cancer

CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment

Care-as-Usual in Patients with Mild Cognitive Impairment

Arm Description

Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis

Randomized controlled Study to Evaluate Care-as-Usual control in Patients with Multiple Sclerosis

Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with with Breast or Lung Cancer

Randomized Controlled Study to Evaluate Care-as-Usual control in Patients with with Breast or Lung Cancer

Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment

Randomized Controlled Study to Evaluate Care-as-Usual in Patients with Mild Cognitive Impairment

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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)
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).
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).

Full Information

First Posted
June 6, 2022
Last Updated
April 25, 2023
Sponsor
Click Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05438147
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
September 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Mild Cognitive Impairment, Cancer
Keywords
Digital therapeutics, Phone app, Virtual study

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active Intervention Device vs. Care-as-Usual Control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis
Arm Type
Active Comparator
Arm Description
Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis
Arm Title
Care-as-Usual control in Patients with Multiple Sclerosis
Arm Type
Sham Comparator
Arm Description
Randomized controlled Study to Evaluate Care-as-Usual control in Patients with Multiple Sclerosis
Arm Title
CT-100 DiNaMo (Study App) in Patients with Breast or Lung Cancer
Arm Type
Active Comparator
Arm Description
Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with with Breast or Lung Cancer
Arm Title
Care-as-Usual control in Patients with Breast or Lung Cancer
Arm Type
Sham Comparator
Arm Description
Randomized Controlled Study to Evaluate Care-as-Usual control in Patients with with Breast or Lung Cancer
Arm Title
CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment
Arm Type
Active Comparator
Arm Description
Randomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment
Arm Title
Care-as-Usual in Patients with Mild Cognitive Impairment
Arm Type
Sham Comparator
Arm Description
Randomized Controlled Study to Evaluate Care-as-Usual in Patients with Mild Cognitive Impairment
Intervention Type
Other
Intervention Name(s)
CT-100 DiNaMo
Intervention Description
Active Treatment (Study App)
Intervention Type
Other
Intervention Name(s)
Care-as-Usual
Intervention Description
Care-As-Usual control
Primary Outcome Measure Information:
Title
PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF)
Description
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)
Time Frame
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Title
Global Rating of Change (GRC-Cognition and GRC-Mood)
Description
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)
Time Frame
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Title
Changes in indication-specific measures of Symbol Digit Modalities Test (SDMT) in Multiple Sclerosis (only)
Description
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).
Time Frame
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Title
Changes in indication-specific measures of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) in Cancer (Breast/Lung; only).
Description
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).
Time Frame
Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Lakhan, MDPhD, FAAN
Organizational Affiliation
Click Therapeutics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacqueline Lutz, PhD
Organizational Affiliation
Click Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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