A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
NCT05994391, Not applicable, Completed, Lindenwood University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults | ClinicalTrials.gov |
| NCT number | NCT05994391 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Lindenwood University | ClinicalTrials.gov |
| Conditions | Cognitive Impairment, Cognitive Decline, Cognition Disorders in Old Age, Well-Being, Psychological, Inflammation, Cognitive Fun | ClinicalTrials.gov |
| Interventions | LasoperinTM, Placeo | ClinicalTrials.gov |
| First posted | 2023-08-16 | ClinicalTrials.gov |
| Last updated | 2023-08-16 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | NIH Toolbox Cognitive Testing - Flanker Inhibitory Control | 30 days | The first test is the Flanker inhibitory control and attention test which tests the participant's attention and executive function. This test requires the participant to maintain attention on a central stimulus while inhibiting the attention to distracting stimuli. The participant will be asked to match the direction of the central arrow while disregarding the surrounding distraction arrows. This test will measure both the reaction time and the accuracy of the participant's decisions. | ClinicalTrials.gov |
| Primary | NIH Toolbox Cognitive Testing - dimensional change card sort test | 30 days | The second test is the dimensional change card sort test which measures a component of executive function known as set-shifting. Set-shifting is the ability to change responses based on a set of rules. In this test the participant will match images based either on color or shape. This test will measure both the reaction time and the accuracy of the participant's decisions. The third test is the pattern comparison processing speed test which measures processing speed. The participants will be shown two images and will be asked to evaluate if they are the same image. This test will measure the number of items that are answered correctly in 85 seconds. | ClinicalTrials.gov |
| Primary | NIH Toolbox Cognitive Testing - Pattern Comparison Processing Speed Test | 30 days | The third test is the pattern comparison processing speed test which measures processing speed. The participants will be shown two images and will be asked to evaluate if they are the same image. This test will measure the number of items that are answered correctly in 85 seconds. | ClinicalTrials.gov |
| Primary | NIH Toolbox General Life Satisfaction Questionnaire | 30 days | The NIH Toolbox was created to standardize the measure of positive and negative aspects of emotions.6 The effect of the study product on the participants' life will be measured using the general life satisfaction questionnaire from the NIH Toolbox. This will measure the participant's satisfaction with themselves and other areas of their life.6 This questionnaire will be completed on Visits 2, 3, and 4. | ClinicalTrials.gov |
| Primary | RAND SF-36 Questionnaire | 30 days | The RAND SF-36 is a short questionnaire that measures health-related quality of life.7 The questionnaire measures eight concepts of health using 36 questions.7 The eight concepts measured are: physical functioning, pain, role limitations due to physical health, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general health. This questionnaire will be completed on Visits 2, 3, and 4. | ClinicalTrials.gov |
| Primary | Stroop Color Test | 30 days | The Stroop color test measures the ability to stop cognitive interference of processing an initial stimulus from interfering with the simultaneous processing of a second stimulus.8 The participant will be tested using an app (Brain Test - Stroop Effect, Attila Hegedus, v1.5.0) on a tablet (iPad, Apple, Inc.). In a seated positions with no other distractions, the participant will be shown two color words, red or green. The words could be written in congruent conditions (e.g., the word red written in red ink) or incongruent conditions (e.g., the word red written in green ink). The participant must select the correct matching ink color for the presented word. The participant will have 60 seconds to match as many conditions correctly as possible. Correct responses add one point and incorrect responses will subtract one point from the total score. The test will be repeated three times and the best score will be recorded. This test will be completed on Visits 2, 3, and 4. | ClinicalTrials.gov |
| Primary | Trail Making Test Parts A & B | 30 days | The trail making test provides information of cognitive processes such as attention, flexibility, and visual search and scanning.9 The participant will be tested using an app (INPL Trail Making Test, Motus Design Group) on a tablet (iPad, Apple, Inc.) in a comfortable seated position. When conducting the test there are two parts, part A and B. Part A requires the participant to tap circled numbers in sequence as quickly as possible (i.e., 1-2-3, etc.). Part B requires the participant to tap both circled numbers and letters in alternating numeric and alphabetical order as quickly as possible (i.e., 1-A-2-B, etc.). The time that it takes to complete each part of the test will be measured. This test will be completed on Visits 2, 3, and 4. | ClinicalTrials.gov |
| Primary | Finger Tapping Test | 30 days | The finger tapping test is commonly used to evaluate the motor function and muscle control of the upper extremities.10 The participant will be tested using an app (Finger Tapping Test, SYBU Data, v3.5) on a tablet (iPad, Apple, Inc.). They will be instructed to sit comfortably in a chair with their palm flat on a desk or table. In this position, the participant will begin the test by tapping on the screen with the index finger of their dominant hand as quickly and consistently as they can in 10 second intervals. The participant will get one practice trial before completing three consecutive trials. Approximately 30 seconds of rest will be given in between each practice and testing trial. After the dominant hand is tested, the participant will repeat the test using the non-dominant hand. Upon completion of the third trial, the average number of taps for both the dominant and non-dominant hand will be calculated and recorded. This test will be completed on Visits 2, 3, and 4 | ClinicalTrials.gov |
| Secondary | Blood Collection - C-Reactive Protein (CRP) | 30 days | CRP is a non-specific indicator for inflammation. Studies have shown that there is an association between elevated levels of CRP and an increased risk of dementia and cerebrovascular disease in clinically compromised populations. | ClinicalTrials.gov |
| Secondary | Blood Collection - Cortisol | 30 days | Both dementia and mild cognitive impairment have been associated with elevated levels of cortisol. Chronic elevated levels of cortisol cause functional atrophy to areas of the brain that are associated with cognitive function. | ClinicalTrials.gov |
| Secondary | Blood Collection - Brain Derived Neurotrophic Factor (BDNF) | 30 days | BDNF is essential in the function of neural processes, and changing levels may contribute neurodegenerative diseases. In conditions of low BDNF there is growing evidence to show that the brain is more susceptible to oxidative stress. | ClinicalTrials.gov |
| Secondary | Blood Collection - Uric Acid | 30 days | Uric acid is a natural antioxidant and contributes greatly to the antioxidant capabilities of blood plasma. Increased oxidative stress has been associated with increased risk of cognitive impairment and dementia. | ClinicalTrials.gov |
| Secondary | Resting Heart Rate | 30 days | 5 minute resting heart rate taken | ClinicalTrials.gov |
| Secondary | Resting Blood Pressure | 30 days | 5 minute resting blood pressure taken | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 6
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 |
|---|---|---|
| Dimensional Change Card Sort | Primary outcome | ConductCognition |
| Finger Tapping Task | Primary outcome | ConductCognition |
| Pattern and Letter Comparison | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary 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)