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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: CT-100 DiNaMo (Other)
Care-as-Usual control in Patients with Multiple Sclerosis
Randomized controlled Study to Evaluate Care-as-Usual control in Patients with Multiple Sclerosis
干预措施: Care-as-Usual (Other)
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
干预措施: CT-100 DiNaMo (Other)
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
干预措施: Care-as-Usual (Other)
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
干预措施: CT-100 DiNaMo (Other)
Care-as-Usual in Patients with Mild Cognitive Impairment
Randomized Controlled Study to Evaluate Care-as-Usual in Patients with Mild Cognitive Impairment
干预措施: Care-as-Usual (Other)
结局指标
主要结局
PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF)
时间窗: 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)
次要结局
- 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)
- 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)