Multiple SclerosisNCT05438147
Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms
A study testing CT-100 DiNaMo and Care-as-Usual in people with Multiple Sclerosis and Mild Cognitive Impairment, run by Click Therapeutics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Mild Cognitive Impairment, Cancer
- What is being tested?
- CT-100 DiNaMo and Care-as-Usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 6 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Mild Cognitive Impairment, Cancer
- Being tested
- CT-100 DiNaMo, Care-as-Usual
- Keywords
- Digital therapeutics, Phone app, Virtual study
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-100 DiNaMoOther
Active Treatment (Study App)
Care-as-UsualOther
Care-As-Usual control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Care-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start13 May 2022
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active Intervention Device vs. Care-as-Usual Control
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, MDPhD, FAAN, Study director, Click TherapeuticsJacqueline Lutz, PhD, Study director, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438147
- Sponsor's protocol ID
- CT-100-D-001
- Status last verified
- Apr 2023
- First submitted
- 6 Jun 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05438147
- Acronym / sponsor ID
- CT-100-D-001
- Conditions
- Multiple Sclerosis, Mild Cognitive Impairment, Cancer
- Keywords
- Digital therapeutics, Phone app, Virtual study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Active Intervention Device vs. Care-as-Usual Control
| Arm | Type | Receives |
|---|---|---|
| CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis | Active comparator | Other: CT-100 DiNaMoRandomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Multiple Sclerosis |
| Care-as-Usual control in Patients with Multiple Sclerosis | Sham comparator | Other: Care-as-UsualRandomized controlled Study to Evaluate Care-as-Usual control in Patients with Multiple Sclerosis |
| CT-100 DiNaMo (Study App) in Patients with Breast or Lung Cancer | Active comparator | Other: CT-100 DiNaMoRandomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with with Breast or Lung Cancer |
| Care-as-Usual control in Patients with Breast or Lung Cancer | Sham comparator | Other: Care-as-UsualRandomized Controlled Study to Evaluate Care-as-Usual control in Patients with with Breast or Lung Cancer |
| CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment | Active comparator | Other: CT-100 DiNaMoRandomized Controlled Study to Evaluate CT-100 DiNaMo (Study App) in Patients with Mild Cognitive Impairment |
| Care-as-Usual in Patients with Mild Cognitive Impairment | Sham comparator | Other: Care-as-UsualRandomized Controlled Study to Evaluate Care-as-Usual in Patients with Mild Cognitive Impairment |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-100 DiNaMoActive Treatment (Study App) | Other | 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-UsualCare-As-Usual control | Other | 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 |
Primary outcome
PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF)
Time frame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
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)
4 secondary outcomes
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
Time frame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Global Rating of Change (GRC-Cognition and GRC-Mood)
Time frame: 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)
Time frame: 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).
Time frame: Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Lakhan, MDPhD, FAAN study director
Click Therapeutics
Jacqueline Lutz, PhD study director
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-100 DiNaMo and Care-as-Usual in people with Multiple Sclerosis and Mild Cognitive Impairment, run by Click Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF) (time frame: Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.