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

NCT05438147 | Completed

• 1 other identifier: CT-100-D-001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Mild Cognitive Impairment; Cancer

Keywords

Digital therapeutics; Phone app; Virtual study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21

• Global Rating of Change (GRC-Cognition and GRC-Mood)

  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)

  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).

  Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21

Study Arms (6)

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

ACTIVE COMPARATOR

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

Other: CT-100 DiNaMo

Care-as-Usual control in Patients with Multiple Sclerosis

SHAM COMPARATOR

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

Other: Care-as-Usual

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

ACTIVE COMPARATOR

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

Other: CT-100 DiNaMo

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

SHAM COMPARATOR

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

Other: Care-as-Usual

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

ACTIVE COMPARATOR

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

Other: CT-100 DiNaMo

Care-as-Usual in Patients with Mild Cognitive Impairment

SHAM COMPARATOR

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

Other: Care-as-Usual

Interventions

CT-100 DiNaMo OTHER

Active Treatment (Study App)

CT-100 DiNaMo (Study App) in Patients with Breast or Lung Cancer; CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment; CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis

Care-as-Usual OTHER

Care-As-Usual control

Care-as-Usual control in Patients with Breast or Lung Cancer; Care-as-Usual control in Patients with Multiple Sclerosis; Care-as-Usual in Patients with Mild Cognitive Impairment

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction; Neoplasms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Shaheen Lakhan, MDPhD, FAAN

  Click Therapeutics

  STUDY DIRECTOR

• Jacqueline Lutz, PhD

  Click Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active Intervention Device vs. Care-as-Usual Control

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 29, 2022
• Study Start: May 13, 2022
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)