Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
NCT06598163, Not applicable, Recruiting, SharpTx
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT06598163 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 170 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | SharpTx | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Five Lives MED | ClinicalTrials.gov |
| First posted | 2024-09-19 | ClinicalTrials.gov |
| Last updated | 2025-04-29 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Montreal Cognitive Assessment (MoCA) | Baseline and Study Exit (12 weeks) | The pen and paper, full version of the Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to detect mild cognitive impairment (MCI) and early signs of dementia. It evaluates several cognitive domains, including short-term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The MoCA is scored out of 30 points, with a score of 26 or above considered normal. Lower scores indicate potential cognitive impairment, with specific ranges often used to gauge the severity: 18-25 for mild cognitive impairment, 10-17 for moderate cognitive impairment, and below 10 for severe cognitive impairment. | ClinicalTrials.gov |
| Secondary | Mild Behavioural Impairment Checklist (MBI-C) | Baseline and Study Exit (12 weeks) | The Mild Behavioral Impairment Checklist (MBI-C) is a 34-item tool designed to detect the onset of neuropsychiatric symptoms that are significant and persistent, particularly in individuals who are at risk for developing dementia. The MBI-C assesses symptoms across five core domains: decreased motivation, affective dysregulation, impulse control, social inappropriateness, and abnormal perception or thought content. Each item in the checklist is rated based on whether the symptom has been present for at least six months, with severity ratings ranging from mild to severe. | ClinicalTrials.gov |
| Secondary | Amsterdam IADL Questionnaire (A-IADL-Q-SV) | Baseline and Study Exit (12 weeks) | The Amsterdam Instrumental Activities of Daily Living Questionnaire - Short Version (A-IADL-Q-SV) is a concise, informant-based tool designed to assess impairments in instrumental activities of daily living (IADL) in individuals with cognitive decline, including those with dementia. The short version consists of 30 items, covering various daily activities such as household tasks, managing finances, using technology, and leisure activities. The total score, or T-score, is normally distributed with a mean of 50 and a standard deviation of 10. The T-score range is approximately 20-80, with higher scores indicating better daily functioning | ClinicalTrials.gov |
| Secondary | D-KEFS Trail Making Test | Baseline and Study Exit (12 weeks) | The Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test is a neuropsychological assessment used to evaluate various aspects of executive functioning, particularly cognitive flexibility, processing speed, and attention. It consists of five conditions that assess visual scanning, number sequencing, letter sequencing, number-letter switching, and motor speed. Each condition has raw and scaled scores, with higher scaled scores indicating better performance. | ClinicalTrials.gov |
| Secondary | 30-second Chair Stand test (30CST) | Baseline and Study Exit (12 weeks) | The 30-Second Chair Stand Test (30CST) is a functional fitness test designed to assess lower body strength and endurance, particularly in older adults. The test involves counting how many times an individual can fully stand up from a seated position and sit back down in a chair without using their arms, all within a 30-second period. A higher score indicates better performance. This test is commonly used to evaluate the risk of falls and overall functional mobility in seniors. | ClinicalTrials.gov |
| Secondary | Five Lives cognitive tests | Baseline and Study Exit (12 weeks) | Five Lives offers five digital cognitive tests via iPad or smartphone, each targeting different cognitive functions. * the Snap test assesses verbal fluency, * the Breeze test measures short-term memory and numerical abilities through word recall tasks, * the Cast test evaluates spatial and numerical memory with increasingly complex grid tasks, * the Swift test, based on the Stroop Task, measures inhibition by requiring participants to identify the meaning or color of words, and * the Twist test assesses processing speed and cognitive control using a digitized version of the Trail Making Test. Higher scores indicate better performance. | ClinicalTrials.gov |
| Secondary | QoL in Alzheimer's disease (QOL-AD) | Baseline and Study Exit (12 weeks) | The Quality of Life in Alzheimer's Disease (QOL-AD) scale is a 13-item questionnaire designed to assess the quality of life of individuals diagnosed with Alzheimer's disease from both the patients and informants perspectives. It measures areas such as physical health, mood, relationships, and the ability to perform daily activities. Each item is rated on a 4-point scale from 1 (poor) to 4 (excellent), with total scores ranging from 13 to 52, where higher scores indicate a better perceived quality of life. | ClinicalTrials.gov |
| Secondary | Alzheimer's Disease Knowledge Scale (ADKS) | Baseline and Study Exit (12 weeks) | The Alzheimer's Disease Knowledge Scale (ADKS) is a 30-item true/false questionnaire designed to assess knowledge about Alzheimers disease across several domains, including risk factors, symptoms, diagnosis, treatment, caregiving, and disease progression. Higher scores indicate better knowledge. | ClinicalTrials.gov |
| Secondary | International Physical Activity Questionnaire (IPAQ) | Baseline and Study Exit (12 weeks) | The International Physical Activity Questionnaire (IPAQ) is a widely used self-report tool designed to measure physical activity levels. The IPAQ has been adapted for use with older adults, including those aged 65 and above. The IPAQ can be particularly useful in assessing physical activity levels in this demographic, helping to understand the frequency, intensity, and duration of various types of physical activity, such as walking, moderate, and vigorous activities. Scores will be expressed in metabolic equivalent (MET)-min per week, which higher MET-min indicating more physical activity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 56
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8618663 | BACKGROUND | PubMed |
| 10190820 | BACKGROUND | PubMed |
| 12021425 | BACKGROUND | PubMed |
| 16631882 | BACKGROUND | PubMed |
| 18345348 | BACKGROUND | PubMed |
| 19363018 | BACKGROUND | PubMed |
| 20837662 | BACKGROUND | PubMed |
| 23303884 | BACKGROUND | PubMed |
| 23985135 | BACKGROUND | PubMed |
| 24672478 | BACKGROUND | PubMed |
| 25405755 | BACKGROUND | PubMed |
| 25444575 | BACKGROUND | PubMed |
| 25771249 | BACKGROUND | PubMed |
| 26338465 | BACKGROUND | PubMed |
| 26539987 | BACKGROUND | PubMed |
| 27042901 | BACKGROUND | PubMed |
| 27423932 | BACKGROUND | PubMed |
| 27431673 | BACKGROUND | PubMed |
| 27608620 | BACKGROUND | PubMed |
| 27716336 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)